Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial

February 5, 2024 updated by: NRG Oncology

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether men with National Comprehensive Cancer Network (NCCN) high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk (=< 0.85) can be treated with 12 months androgen deprivation therapy (ADT) plus radiation therapy (RT) instead of 24 months ADT+RT and experience non-inferior metastasis-free survival. (De-intensification study) II. To determine whether men with NCCN high risk prostate cancer who are in the upper 1/3 of Decipher genomic risk (> 0.85) or have node-positive disease by conventional imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) will have a superior metastasis-free survival (MFS) through treatment intensification with apalutamide added to the standard of RT plus 24 month ADT. (Intensification study)

SECONDARY OBJECTIVES:

I. To compare overall survival (OS) between the standard of care (RT plus 24 months of ADT) and either the de-intensification (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) II. To compare time to prostate specific antigen (PSA) failure or start of salvage treatment between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) III. To compare PSA failure-free survival with non-castrate testosterone and no additional therapies between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) IV. To compare MFS judged based on either standard or molecular imaging between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) V. To compare prostate cancer-specific mortality between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) VI. To compare testosterone levels at the time of PSA failure and metastases between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) VII. To compare time to testosterone recovery (defined as a T > 200) between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) VIII. To compare adverse events, both clinician-reported using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 and patient-reported using Patient Reported Outcome (PRO)-CTCAE items, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies)

EXPLORATORY OBJECTIVES:

I. To compare changes in cardio-metabolic markers, including body mass index, and waist circumference, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide). (De-intensification and intensification studies) II. To determine a machine learning/artificial intelligence algorithm for radiotherapy quality assurance. (De-intensification and Intensification studies) III. To perform future translational correlative studies using biological and imaging data. (De-intensification and intensification studies) IV. Impact of PET use in high-risk prostate cancer

PATIENT-REPORTED OUTCOMES OBJECTIVES:

PRIMARY OBJECTIVES:

I. To compare sexual and hormonal function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) II. To compare fatigue, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue instrument, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

SECONDARY OBJECTIVES:

I. To compare depression, as measured by the PROMIS-depression, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) II. To compare depression, as measured by the PROMIS-depression, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

EXPLORATORY OBJECTIVES:

I. To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) II. To compare bowel and urinary function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) III. To compare fatigue, as measured by the PROMIS-Fatigue instrument, between the standard of care (RT plus 24 months of ADT) and the de-intensification arm (RT plus 12 months of ADT). (De-Intensification Study) IV. To compare sexual and hormonal function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study) V. To compare bowel and urinary function related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study) VI. To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 24 months of ADT) and the intensification arm (RT plus 24 months of ADT plus apalutamide). (Intensification Study)

OUTLINE: Patients are randomized to 1 of 4 arms.

DE-INTENSIFICATION STUDY (DECIPHER SCORE =< 0.85):

ARM I: Patients undergo radiation therapy (RT) over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 12 months in the absence of disease progression or unacceptable toxicity.

INTENSIFICATION STUDY (DECIPHER SCORE > 0.85 OR NODE POSITIVE):

ARM III: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.

ARM IV: Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin) for 24 months in the absence of disease progression or unacceptable toxicity. Patients also receive apalutamide orally (PO) once daily (QD). Treatment repeats every 90 days for up to 8 cycles (24 months) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up annually.

Study Type

Interventional

Enrollment (Estimated)

2478

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 403-521-3433
        • Principal Investigator:
          • Alexander G. Balogh
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital and Cancer Center-General Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 613-761-4395
        • Principal Investigator:
          • Scott C. Morgan
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network-Princess Margaret Hospital
        • Principal Investigator:
          • Srinivas Raman
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3H 2R9
        • Recruiting
        • The Research Institute of the McGill University Health Centre (MUHC)
        • Contact:
        • Principal Investigator:
          • Marie Duclos
      • Quebec City, Quebec, Canada, G1R 2J6
        • Recruiting
        • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
        • Contact:
        • Principal Investigator:
          • Eric Vigneault
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
        • Contact:
        • Principal Investigator:
          • Audrey Tetreault-Laflamme
  • United States
    • Alaska
      • Fairbanks, Alaska, United States, 99701
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Arizona Breast Cancer Specialists-Gilbert
        • Contact:
          • Site Public Contact
          • Phone Number: 480-922-4600
        • Principal Investigator:
          • Christopher A. Biggs
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Arizona Center for Cancer Care-Peoria
        • Principal Investigator:
          • Christopher A. Biggs
        • Contact:
          • Site Public Contact
          • Phone Number: 623-773-2873
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Arizona Breast Cancer Specialists-Scottsdale
        • Contact:
          • Site Public Contact
          • Phone Number: 480-922-4600
        • Principal Investigator:
          • Christopher A. Biggs
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-North Campus
        • Contact:
        • Principal Investigator:
          • Shona T. Dougherty
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 501-686-8274
        • Principal Investigator:
          • Sanjay Maraboyina
    • California
      • Auburn, California, United States, 95603
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
        • Principal Investigator:
          • Christopher U. Jones
        • Contact:
      • Bakersfield, California, United States, 93301
        • Recruiting
        • AIS Cancer Center at San Joaquin Community Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 661-323-4673
        • Principal Investigator:
          • Ricardo Salas
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Tanya B. Dorff
      • Dublin, California, United States, 94568
        • Recruiting
        • Kaiser Permanente Dublin
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
        • Principal Investigator:
          • Samantha A. Seaward
      • Fremont, California, United States, 94538
        • Recruiting
        • Kaiser Permanente-Fremont
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Fremont, California, United States, 94538
        • Recruiting
        • Washington Hospital
        • Principal Investigator:
          • Jes Alexander
        • Contact:
          • Site Public Contact
          • Phone Number: 510-745-6433
      • Fresno, California, United States, 93720
        • Recruiting
        • Kaiser Permanente-Fresno
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Greenbrae, California, United States, 94904
        • Recruiting
        • Marin General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 415-925-7325
        • Principal Investigator:
          • Lloyd T. Miyawaki
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope at Irvine Lennar
        • Contact:
          • Site Public Contact
          • Phone Number: 877-467-3411
        • Principal Investigator:
          • Tanya B. Dorff
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Tyler M. Seibert
        • Contact:
      • Lancaster, California, United States, 93534
        • Recruiting
        • City of Hope Antelope Valley
        • Contact:
        • Principal Investigator:
          • Tanya B. Dorff
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 310-423-8965
        • Principal Investigator:
          • Zachary S. Zumsteg
      • Los Angeles, California, United States, 90033
        • Active, not recruiting
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Active, not recruiting
        • Los Angeles General Medical Center
      • Marysville, California, United States, 95901
        • Recruiting
        • Fremont - Rideout Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 530-749-4400
        • Principal Investigator:
          • Richard K. Valicenti
      • Modesto, California, United States, 95355
      • Modesto, California, United States, 95356
        • Recruiting
        • Kaiser Permanente-Modesto
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Napa, California, United States, 94558
        • Recruiting
        • Providence Queen of The Valley
        • Principal Investigator:
          • Nitya Alluri
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente-Oakland
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Orange, California, United States, 92868
        • Recruiting
        • Saint Joseph Hospital - Orange
        • Contact:
          • Site Public Contact
          • Phone Number: 714-734-6220
        • Principal Investigator:
          • John Wong
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Principal Investigator:
          • Steven N. Seyedin
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute Palo Alto
        • Principal Investigator:
          • Hilary Bagshaw
        • Contact:
      • Roseville, California, United States, 95661
        • Recruiting
        • Kaiser Permanente-Roseville
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Roseville, California, United States, 95661
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
        • Principal Investigator:
          • Christopher U. Jones
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Richard K. Valicenti
      • Sacramento, California, United States, 95814
        • Recruiting
        • Kaiser Permanente Downtown Commons
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Sacramento, California, United States, 95816
      • Sacramento, California, United States, 95823
        • Recruiting
        • Kaiser Permanente-South Sacramento
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Medical Center-Mission Bay
        • Principal Investigator:
          • Bradley C. Ekstrand
        • Contact:
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente-San Francisco
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • San Jose, California, United States, 95119
        • Recruiting
        • Kaiser Permanente-Santa Teresa-San Jose
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • San Jose, California, United States, 95124
        • Recruiting
        • Stanford Cancer Center South Bay
        • Principal Investigator:
          • Hilary Bagshaw
        • Contact:
      • San Leandro, California, United States, 94577
        • Recruiting
        • Kaiser Permanente San Leandro
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • San Mateo, California, United States, 94402
        • Recruiting
        • UCSF Cancer Center - San Mateo
        • Principal Investigator:
          • Bradley C. Ekstrand
        • Contact:
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • Ridley-Tree Cancer Center
        • Contact:
        • Principal Investigator:
          • Justin C. Voog
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente Medical Center - Santa Clara
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Kaiser Permanente-Santa Rosa
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • South Pasadena, California, United States, 91030
        • Recruiting
        • City of Hope South Pasadena
        • Contact:
        • Principal Investigator:
          • Tanya B. Dorff
      • South San Francisco, California, United States, 94080
        • Recruiting
        • Kaiser Permanente-South San Francisco
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Tarzana, California, United States, 91356
        • Recruiting
        • Cedars-Sinai Cancer - Tarzana
        • Contact:
          • Site Public Contact
          • Phone Number: 818-981-3818
        • Principal Investigator:
          • Zachary S. Zumsteg
      • Torrance, California, United States, 90505
        • Recruiting
        • Torrance Memorial Physician Network - Cancer Care
        • Contact:
        • Principal Investigator:
          • Zachary S. Zumsteg
      • Torrance, California, United States, 90509
        • Recruiting
        • Torrance Memorial Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 310-517-4665
        • Principal Investigator:
          • Zachary S. Zumsteg
      • Torrance, California, United States, 90503
        • Suspended
        • City of Hope South Bay
      • Truckee, California, United States, 96161
        • Recruiting
        • Gene Upshaw Memorial Tahoe Forest Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 530-582-6450
        • Principal Investigator:
          • Richard K. Valicenti
      • Upland, California, United States, 91786
        • Recruiting
        • City of Hope Upland
        • Contact:
        • Principal Investigator:
          • Tanya B. Dorff
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente-Vallejo
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Kaiser Permanente-Walnut Creek
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • John Muir Medical Center-Walnut Creek
        • Contact:
          • Site Public Contact
          • Phone Number: 925-941-4246
        • Principal Investigator:
          • James L. Rembert
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth University of Colorado Hospital
        • Principal Investigator:
          • Tyler Robin
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
      • Boulder, Colorado, United States, 80304
        • Recruiting
        • Rocky Mountain Cancer Centers-Boulder
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • UCHealth Memorial Hospital Central
        • Principal Investigator:
          • Tyler Robin
        • Contact:
          • Site Public Contact
          • Phone Number: 719-365-2406
      • Colorado Springs, Colorado, United States, 80920
        • Recruiting
        • Memorial Hospital North
        • Principal Investigator:
          • Tyler Robin
        • Contact:
          • Site Public Contact
          • Phone Number: 719-364-6700
      • Edwards, Colorado, United States, 81632
        • Recruiting
        • Shaw Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 970-569-7429
        • Principal Investigator:
          • Erin Schwab
      • Fort Collins, Colorado, United States, 80524
        • Recruiting
        • Poudre Valley Hospital
        • Principal Investigator:
          • Tyler Robin
        • Contact:
          • Site Public Contact
          • Phone Number: 970-297-6150
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Cancer Care and Hematology-Fort Collins
        • Principal Investigator:
          • Tyler Robin
        • Contact:
      • Greeley, Colorado, United States, 80631
      • Greeley, Colorado, United States, 80631
        • Recruiting
        • UCHealth Greeley Hospital
        • Principal Investigator:
          • Tyler Robin
        • Contact:
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • UCHealth Highlands Ranch Hospital
        • Principal Investigator:
          • Tyler Robin
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
      • Loveland, Colorado, United States, 80539
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • Medical Center of the Rockies
        • Principal Investigator:
          • Tyler Robin
        • Contact:
          • Site Public Contact
          • Phone Number: 970-203-7083
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Recruiting
        • Hartford HealthCare - Saint Vincent's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 860-972-4700
        • Principal Investigator:
          • Christopher M. Iannuzzi
      • Derby, Connecticut, United States, 06418
        • Recruiting
        • Smilow Cancer Hospital-Derby Care Center
        • Principal Investigator:
          • Yi An
        • Contact:
      • Fairfield, Connecticut, United States, 06824
        • Recruiting
        • Smilow Cancer Hospital Care Center-Fairfield
        • Principal Investigator:
          • Yi An
        • Contact:
      • Greenwich, Connecticut, United States, 06830
        • Recruiting
        • Smilow Cancer Hospital Care Center at Greenwich
        • Principal Investigator:
          • Yi An
        • Contact:
      • Guilford, Connecticut, United States, 06437
        • Recruiting
        • Smilow Cancer Hospital Care Center - Guilford
        • Principal Investigator:
          • Yi An
        • Contact:
      • Hartford, Connecticut, United States, 06105
        • Recruiting
        • Smilow Cancer Hospital Care Center at Saint Francis
        • Principal Investigator:
          • Yi An
        • Contact:
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Principal Investigator:
          • Christopher M. Iannuzzi
        • Contact:
          • Site Public Contact
          • Phone Number: 860-545-5363
      • Meriden, Connecticut, United States, 06451
        • Recruiting
        • Midstate Medical Center
        • Principal Investigator:
          • Christopher M. Iannuzzi
        • Contact:
          • Site Public Contact
          • Phone Number: 866-662-5678
      • New Britain, Connecticut, United States, 06050
        • Recruiting
        • The Hospital of Central Connecticut
        • Principal Investigator:
          • Christopher M. Iannuzzi
        • Contact:
          • Site Public Contact
          • Phone Number: 860-224-5660
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Yi An
        • Contact:
      • North Haven, Connecticut, United States, 06473
        • Recruiting
        • Yale-New Haven Hospital North Haven Medical Center
        • Principal Investigator:
          • Yi An
        • Contact:
      • Orange, Connecticut, United States, 06477
        • Recruiting
        • Smilow Cancer Hospital-Orange Care Center
        • Principal Investigator:
          • Yi An
        • Contact:
      • Stamford, Connecticut, United States, 06904
        • Recruiting
        • Stamford Hospital/Bennett Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 203-323-8944
        • Principal Investigator:
          • Anthony P. Gulati
      • Stamford, Connecticut, United States, 06902
        • Recruiting
        • Smilow Cancer Hospital Care Center at Long Ridge
        • Principal Investigator:
          • Yi An
        • Contact:
      • Trumbull, Connecticut, United States, 06611
        • Recruiting
        • Smilow Cancer Hospital Care Center-Trumbull
        • Principal Investigator:
          • Yi An
        • Contact:
      • Waterford, Connecticut, United States, 06385
        • Recruiting
        • Smilow Cancer Hospital Care Center - Waterford
        • Principal Investigator:
          • Yi An
        • Contact:
    • Delaware
      • Dover, Delaware, United States, 19901
        • Recruiting
        • Bayhealth Hospital Kent Campus
        • Contact:
        • Principal Investigator:
          • Iftekhar A. Khan
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Boca Raton Regional Hospital
        • Principal Investigator:
          • Spencer Bachow
        • Contact:
          • Site Public Contact
          • Phone Number: 561-955-4800
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Health Science Center - Gainesville
        • Contact:
        • Principal Investigator:
          • Jonathan A. Chatzkel
      • Lakewood Ranch, Florida, United States, 34202
        • Suspended
        • GenesisCare USA - Lakewood Ranch
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute
        • Principal Investigator:
          • Bruno R. Bastos
        • Contact:
          • Site Public Contact
          • Phone Number: 786-596-2000
      • Plantation, Florida, United States, 33324
        • Recruiting
        • GenesisCare USA - Plantation
        • Contact:
        • Principal Investigator:
          • Frank A. Vicini
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Principal Investigator:
          • John David
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Vishal R. Dhere
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Contact:
          • Site Public Contact
          • Phone Number: 404-489-9164
        • Principal Investigator:
          • Vishal R. Dhere
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Vishal R. Dhere
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
        • Principal Investigator:
          • Vishal R. Dhere
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory Proton Therapy Center
        • Contact:
        • Principal Investigator:
          • Vishal R. Dhere
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
        • Contact:
        • Principal Investigator:
          • John A. Pablo
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Principal Investigator:
          • Daniel H. Barnett
        • Contact:
      • Barrington, Illinois, United States, 60010
        • Recruiting
        • Advocate Good Shepherd Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-842-4847
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Dian Wang
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Stanley L. Liauw
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Sean Sachdev
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Matthew Koshy
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 773-296-5360
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Crystal Lake, Illinois, United States, 60014
        • Recruiting
        • AMG Crystal Lake - Oncology
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Principal Investigator:
          • Daniel H. Barnett
        • Contact:
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • Sean Sachdev
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Advocate Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Advocate Sherman Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-429-2907
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Elmhurst Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Brian C. Myre
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Principal Investigator:
          • Amit D. Bhate
        • Contact:
      • Hazel Crest, Illinois, United States, 60429
        • Recruiting
        • Advocate South Suburban Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 708-799-9995
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Lake Forest, Illinois, United States, 60045
        • Recruiting
        • Northwestern Medicine Lake Forest Hospital
        • Contact:
        • Principal Investigator:
          • Sean Sachdev
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • AMG Libertyville - Oncology
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • Condell Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Principal Investigator:
          • Daniel H. Barnett
        • Contact:
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
        • Principal Investigator:
          • Abhishek A. Solanki
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Edward Hospital/Cancer Center
        • Principal Investigator:
          • Brian C. Myre
        • Contact:
          • Site Public Contact
          • Phone Number: 630-646-6075
      • New Lenox, Illinois, United States, 60451
        • Recruiting
        • UC Comprehensive Cancer Center at Silver Cross
        • Contact:
        • Principal Investigator:
          • Stanley L. Liauw
      • Oak Lawn, Illinois, United States, 60453-2699
        • Recruiting
        • Advocate Christ Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-323-8622
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • University of Chicago Medicine-Orland Park
        • Contact:
        • Principal Investigator:
          • Stanley L. Liauw
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-384-3621
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61636
        • Recruiting
        • Methodist Medical Center of Illinois
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Rockford, Illinois, United States, 61114
        • Recruiting
        • SwedishAmerican Regional Cancer Center/ACT
        • Principal Investigator:
          • Harvey E. Einhorn
        • Contact:
      • Shiloh, Illinois, United States, 62269
        • Recruiting
        • Memorial Hospital East
        • Contact:
        • Principal Investigator:
          • Jeff M. Michalski
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Memorial Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Principal Investigator:
          • Daniel H. Barnett
        • Contact:
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Sean Sachdev
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Mercy Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 319-365-4673
        • Principal Investigator:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Oncology Associates at Mercy Medical Center
        • Principal Investigator:
          • Deborah W. Wilbur
        • Contact:
          • Site Public Contact
          • Phone Number: 319-363-2690
      • Cedar Rapids, Iowa, United States, 52402
        • Recruiting
        • Saint Luke's Hospital
        • Contact:
        • Principal Investigator:
          • Robert J. Isaak
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Medical Oncology and Hematology Associates-Des Moines
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Broadlawns Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2200
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • Xinglei Shen
      • Olathe, Kansas, United States, 66061
        • Recruiting
        • Olathe Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Xinglei Shen
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • University of Kansas Cancer Center-Overland Park
        • Contact:
        • Principal Investigator:
          • Xinglei Shen
      • Salina, Kansas, United States, 67401
        • Recruiting
        • Salina Regional Health Center
        • Contact:
        • Principal Investigator:
          • Xinglei Shen
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • University of Kansas Health System Saint Francis Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 785-295-8000
        • Principal Investigator:
          • Xinglei Shen
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Contact:
        • Principal Investigator:
          • Xinglei Shen
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Ascension Via Christi Hospitals Wichita
        • Contact:
        • Principal Investigator:
          • Dennis F. Moore
    • Kentucky
      • Lexington, Kentucky, United States, 40509
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
      • Metairie, Louisiana, United States, 70006
        • Suspended
        • East Jefferson General Hospital
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University School of Medicine
        • Principal Investigator:
          • Audrey Dang
        • Contact:
    • Maine
      • Bath, Maine, United States, 04530
        • Recruiting
        • MaineHealth Coastal Cancer Treatment Center
        • Contact:
        • Principal Investigator:
          • Matthew D. Cheney
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Medical Center-Bramhall Campus
        • Principal Investigator:
          • Matthew D. Cheney
        • Contact:
          • Site Public Contact
          • Phone Number: 207-885-7565
      • Rockport, Maine, United States, 04856
        • Recruiting
        • Penobscot Bay Medical Center
        • Contact:
        • Principal Investigator:
          • Matthew D. Cheney
      • Sanford, Maine, United States, 04073
        • Recruiting
        • MaineHealth Cancer Care Center of York County
        • Principal Investigator:
          • Matthew D. Cheney
        • Contact:
          • Site Public Contact
          • Phone Number: 207-459-1600
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Maine Medical Center- Scarborough Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 207-396-8090
          • Email: wrighd@mmc.org
        • Principal Investigator:
          • Matthew D. Cheney
      • South Portland, Maine, United States, 04106
        • Recruiting
        • Maine Medical Partners - South Portland
        • Contact:
        • Principal Investigator:
          • Matthew D. Cheney
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Anne Arundel Medical Center
        • Contact:
        • Principal Investigator:
          • Antony Koroulakis
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Contact:
        • Principal Investigator:
          • Daniel Y. Song
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland/Greenebaum Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-888-8823
        • Principal Investigator:
          • Zaker H. Rana
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Maryland Proton Treatment Center
        • Principal Investigator:
          • Zaker H. Rana
        • Contact:
      • Bel Air, Maryland, United States, 21014
        • Recruiting
        • UM Upper Chesapeake Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 443-643-3010
        • Principal Investigator:
          • Jack J. Hong
      • Bethesda, Maryland, United States, 20814
        • Recruiting
        • Suburban Hospital
        • Contact:
        • Principal Investigator:
          • Daniel Y. Song
      • Easton, Maryland, United States, 21601
        • Recruiting
        • University of Maryland Shore Medical Center at Easton
        • Principal Investigator:
          • John P. Mastandrea
        • Contact:
      • Glen Burnie, Maryland, United States, 21061
        • Suspended
        • UM Baltimore Washington Medical Center/Tate Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-726-5130
        • Principal Investigator:
          • Jason A. Efstathiou
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Paul L. Nguyen
        • Contact:
          • Site Public Contact
          • Phone Number: 877-442-3324
      • Boston, Massachusetts, United States, 02115
        • Suspended
        • Brigham and Women's Hospital
      • Milford, Massachusetts, United States, 01757
        • Recruiting
        • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
        • Principal Investigator:
          • Peter F. Orio
        • Contact:
          • Site Public Contact
          • Phone Number: 877-332-4294
      • South Weymouth, Massachusetts, United States, 02190
        • Recruiting
        • Dana-Farber/Brigham and Women's Cancer Center at South Shore
        • Principal Investigator:
          • Peter F. Orio
        • Contact:
          • Site Public Contact
          • Phone Number: 781-624-5000
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Principal Investigator:
          • Robert Dess
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • McLaren Cancer Institute-Bay City
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Brighton, Michigan, United States, 48114
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Brighton, Michigan, United States, 48116
        • Recruiting
        • University of Michigan - Brighton Center for Specialty Care
        • Principal Investigator:
          • Robert Dess
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
      • Brownstown, Michigan, United States, 48183
        • Suspended
        • Henry Ford Cancer Institute-Downriver
      • Canton, Michigan, United States, 48188
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Chelsea, Michigan, United States, 48118
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • McLaren Cancer Institute-Clarkston
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • Michigan Healthcare Professionals Clarkston
        • Principal Investigator:
          • Frank A. Vicini
        • Contact:
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Henry Ford Macomb Hospital-Clinton Township
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
      • Dearborn, Michigan, United States, 48124
        • Recruiting
        • Beaumont Hospital - Dearborn
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
        • Principal Investigator:
          • Daniel J. Krauss
      • Dearborn, Michigan, United States, 48126
        • Suspended
        • Henry Ford Medical Center-Fairlane
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University/Karmanos Cancer Institute
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Weisberg Cancer Treatment Center
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Michigan Healthcare Professionals Farmington
        • Principal Investigator:
          • Frank A. Vicini
        • Contact:
      • Flint, Michigan, United States, 48532
        • Recruiting
        • McLaren Cancer Institute-Flint
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Sparrow Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 517-364-9400
        • Principal Investigator:
          • Samir Narayan
      • Lansing, Michigan, United States, 48910
        • Recruiting
        • Karmanos Cancer Institute at McLaren Greater Lansing
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Lapeer, Michigan, United States, 48446
        • Recruiting
        • McLaren Cancer Institute-Lapeer Region
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Michigan Healthcare Professionals Macomb
        • Principal Investigator:
          • Frank A. Vicini
        • Contact:
      • Madison Heights, Michigan, United States, 48071
        • Recruiting
        • Michigan Healthcare Professionals Madison Heights
        • Principal Investigator:
          • Frank A. Vicini
        • Contact:
      • Mount Clemens, Michigan, United States, 48043
        • Recruiting
        • McLaren Cancer Institute-Macomb
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Novi, Michigan, United States, 48377
        • Suspended
        • Henry Ford Medical Center-Columbus
      • Port Huron, Michigan, United States, 48060
        • Recruiting
        • McLaren-Port Huron
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • William Beaumont Hospital-Royal Oak
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
        • Principal Investigator:
          • Daniel J. Krauss
      • Saginaw, Michigan, United States, 48601
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Shelby, Michigan, United States, 48315
        • Suspended
        • Henry Ford Macomb Health Center - Shelby Township
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Troy, Michigan, United States, 48085
        • Recruiting
        • William Beaumont Hospital - Troy
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
        • Principal Investigator:
          • Daniel J. Krauss
      • Troy, Michigan, United States, 48098
      • West Bloomfield, Michigan, United States, 48322
        • Recruiting
        • Henry Ford West Bloomfield Hospital
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Samir Narayan
    • Minnesota
      • Albert Lea, Minnesota, United States, 56007
        • Suspended
        • Mayo Clinic Health System in Albert Lea
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Charles Shideman
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Miller-Dwan Hospital
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Fridley, Minnesota, United States, 55432
        • Active, not recruiting
        • Unity Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Charles Shideman
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • Charles Shideman
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • Charles Shideman
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Bradley J. Stish
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • Charles Shideman
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Charles Shideman
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 601-815-6700
        • Principal Investigator:
          • John C. Henegan
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • MU Health - University Hospital/Ellis Fischel Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 573-882-7440
        • Principal Investigator:
          • Gregory B. Biedermann
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Jeff M. Michalski
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • University of Kansas Cancer Center - North
        • Contact:
        • Principal Investigator:
          • Xinglei Shen
      • Lee's Summit, Missouri, United States, 64064
        • Recruiting
        • University of Kansas Cancer Center - Lee's Summit
        • Contact:
        • Principal Investigator:
          • Xinglei Shen
      • North Kansas City, Missouri, United States, 64116
        • Recruiting
        • University of Kansas Cancer Center at North Kansas City Hospital
        • Contact:
        • Principal Investigator:
          • Xinglei Shen
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Delbert Day Cancer Institute at PCRMC
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Jeff M. Michalski
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Saint Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Jeff M. Michalski
      • Saint Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Contact:
        • Principal Investigator:
          • Jeff M. Michalski
      • Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Jeff M. Michalski
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Nebraska Medicine-Bellevue
        • Contact:
        • Principal Investigator:
          • Michael J. Baine
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Michael J. Baine
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Medicine-Village Pointe
        • Contact:
          • Site Public Contact
          • Phone Number: 402-559-5600
        • Principal Investigator:
          • Michael J. Baine
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • Recruiting
        • New Hampshire Oncology Hematology PA-Concord
        • Contact:
          • Site Public Contact
          • Phone Number: 603-224-2556
        • Principal Investigator:
          • Douglas J. Weckstein
      • Exeter, New Hampshire, United States, 03833
        • Recruiting
        • Exeter Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 800-439-3837
        • Principal Investigator:
          • Virginia W. Osborn
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Nirav S. Kapadia
      • Manchester, New Hampshire, United States, 03103
        • Recruiting
        • Solinsky Center for Cancer Care
        • Principal Investigator:
          • Douglas J. Weckstein
        • Contact:
          • Site Public Contact
          • Phone Number: 800-339-6484
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper Hospital University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 856-325-6757
        • Principal Investigator:
          • Gary Eastwick
      • Egg Harbor Township, New Jersey, United States, 08234
        • Recruiting
        • AtlantiCare Surgery Center
        • Principal Investigator:
          • James C. Wurzer
        • Contact:
          • Site Public Contact
          • Phone Number: 609-748-7200
      • Hamilton, New Jersey, United States, 08690
        • Recruiting
        • The Cancer Institute of New Jersey Hamilton
        • Principal Investigator:
          • Malcolm D. Mattes
        • Contact:
          • Site Public Contact
          • Phone Number: 609-631-6946
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • Saint Barnabas Medical Center
        • Principal Investigator:
          • Malcolm D. Mattes
        • Contact:
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Principal Investigator:
          • Malcolm D. Mattes
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
      • Newark, New Jersey, United States, 07101
        • Recruiting
        • Rutgers New Jersey Medical School
        • Principal Investigator:
          • Malcolm D. Mattes
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
      • Paramus, New Jersey, United States, 07652
        • Recruiting
        • The Valley Hospital-Luckow Pavilion
        • Principal Investigator:
          • Thomas P. Kole
        • Contact:
          • Site Public Contact
          • Phone Number: 201-634-5792
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • Valley Hospital
        • Principal Investigator:
          • Thomas P. Kole
        • Contact:
      • Somerville, New Jersey, United States, 08876
        • Recruiting
        • Robert Wood Johnson University Hospital Somerset
        • Principal Investigator:
          • Malcolm D. Mattes
        • Contact:
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • Malcolm D. Mattes
        • Contact:
      • Voorhees, New Jersey, United States, 08043
        • Recruiting
        • MD Anderson Cancer Center at Cooper-Voorhees
        • Contact:
          • Site Public Contact
          • Phone Number: 856-325-6757
        • Principal Investigator:
          • Gary Eastwick
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Neda Hashemi Sadraei
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Lovelace Medical Center-Saint Joseph Square
        • Contact:
        • Principal Investigator:
          • Neda Hashemi Sadraei
      • Albuquerque, New Mexico, United States, 87110
        • Recruiting
        • Presbyterian Kaseman Hospital
        • Contact:
        • Principal Investigator:
          • Neda Hashemi Sadraei
      • Albuquerque, New Mexico, United States, 87109
        • Suspended
        • Lovelace Radiation Oncology
      • Rio Rancho, New Mexico, United States, 87124
        • Recruiting
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
        • Contact:
        • Principal Investigator:
          • Neda Hashemi Sadraei
    • New York
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • Northwell Health Imbert Cancer Center
        • Principal Investigator:
          • Louis Potters
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • New York-Presbyterian/Brooklyn Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Hani L. Ashamalla
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Principal Investigator:
          • Michael R. Kuettel
        • Contact:
      • Canandaigua, New York, United States, 14424
        • Suspended
        • Sands Cancer Center
      • Dansville, New York, United States, 14437
        • Suspended
        • Noyes Memorial Hospital/Myers Cancer Center
      • Flushing, New York, United States, 11355
        • Recruiting
        • The New York Hospital Medical Center of Queens
        • Principal Investigator:
          • Steven J. DiBiase
        • Contact:
      • Forest Hills, New York, United States, 11375
        • Recruiting
        • Northwell Health Physicians Partners Radiation Medicine at Queens
        • Principal Investigator:
          • Louis Potters
        • Contact:
          • Site Public Contact
          • Phone Number: 718-520-6620
      • Glens Falls, New York, United States, 12801
        • Recruiting
        • Glens Falls Hospital
        • Principal Investigator:
          • Timothy M. Zagar
        • Contact:
          • Site Public Contact
          • Phone Number: 518-926-6700
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/Center for Advanced Medicine
        • Principal Investigator:
          • Louis Potters
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
      • New York, New York, United States, 10032
        • Recruiting
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Israel Deutsch
      • New York, New York, United States, 10065
        • Recruiting
        • NYP/Weill Cornell Medical Center
        • Principal Investigator:
          • Himanshu Nagar
        • Contact:
          • Site Public Contact
          • Phone Number: 212-746-1848
      • New York, New York, United States, 10021
        • Recruiting
        • Lenox Hill Hospital
        • Principal Investigator:
          • Louis Potters
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
      • New York, New York, United States, 10065
        • Recruiting
        • Manhattan Eye Ear and Throat Hospital
        • Principal Investigator:
          • Louis Potters
        • Contact:
          • Site Public Contact
          • Phone Number: 212-434-4460
      • Rego Park, New York, United States, 11374
        • Recruiting
        • Queens Cancer Center
        • Principal Investigator:
          • Louis Potters
        • Contact:
          • Site Public Contact
          • Phone Number: 718-312-3446
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Principal Investigator:
          • Yuhchyau Chen
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
      • Rochester, New York, United States, 14620
        • Suspended
        • Highland Hospital
      • Sleepy Hollow, New York, United States, 10591
        • Recruiting
        • Phelps Memorial Hospital Center
        • Principal Investigator:
          • Louis Potters
        • Contact:
          • Site Public Contact
          • Phone Number: 914-366-1600
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Principal Investigator:
          • Alexander N. Slade
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Principal Investigator:
          • Alexander V. Banashkevich
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Westchester Medical Center
        • Contact:
        • Principal Investigator:
          • Mark D. Hurwitz
      • Webster, New York, United States, 14580
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Suspended
        • Duke Cancer Institute Cary
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Principal Investigator:
          • Matthew C. Ward
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Presbyterian Medical Center
        • Contact:
        • Principal Investigator:
          • Catherine E. Moore
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • Atrium Health Pineville/LCI-Pineville
        • Principal Investigator:
          • Matthew C. Ward
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
      • Charlotte, North Carolina, United States, 28262
        • Recruiting
        • Atrium Health University City/LCI-University
        • Principal Investigator:
          • Matthew C. Ward
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Levine Cancer Institute-Ballantyne
        • Principal Investigator:
          • Matthew C. Ward
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Concord, North Carolina, United States, 28025
        • Recruiting
        • Atrium Health Cabarrus/LCI-Concord
        • Principal Investigator:
          • Matthew C. Ward
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
        • Principal Investigator:
          • Ryan E. Fecteau
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Durham VA Medical Center
        • Principal Investigator:
          • Matthew J. Boyer
        • Contact:
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Novant Health Cancer Institute - Huntersville
        • Contact:
        • Principal Investigator:
          • Catherine E. Moore
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • Novant Health Cancer Institute - Matthews
        • Contact:
        • Principal Investigator:
          • Catherine E. Moore
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Atrium Health Union/LCI-Union
        • Principal Investigator:
          • Matthew C. Ward
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
      • Mooresville, North Carolina, United States, 28117
        • Recruiting
        • Novant Health Cancer Institute - Mooresville
        • Contact:
        • Principal Investigator:
          • Catherine E. Moore
      • Raleigh, North Carolina, United States, 27609
        • Recruiting
        • Duke Raleigh Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 919-862-5400
        • Principal Investigator:
          • Ryan E. Fecteau
      • Raleigh, North Carolina, United States, 27607
      • Raleigh, North Carolina, United States, 27614
      • Supply, North Carolina, United States, 28462
        • Recruiting
        • Novant Cancer Institute Radiation Oncology - Supply
        • Contact:
          • Site Public Contact
          • Phone Number: 910-754-4716
        • Principal Investigator:
          • Michael A. Papagikos
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Novant Health New Hanover Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 910-342-3000
        • Principal Investigator:
          • Michael A. Papagikos
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Novant Health Cancer Institute Radiation Oncology - Wilmington
        • Principal Investigator:
          • Michael A. Papagikos
        • Contact:
          • Site Public Contact
          • Phone Number: 910-251-1839
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • Michael McCormack
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Forsyth Medical Center
        • Contact:
        • Principal Investigator:
          • Timothy S. Collins
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Recruiting
        • Altru Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 701-780-6520
        • Principal Investigator:
          • Grant R. Seeger
    • Ohio
      • Akron, Ohio, United States, 44307
        • Recruiting
        • Cleveland Clinic Akron General
        • Principal Investigator:
          • Ashok Ramalingam
        • Contact:
      • Akron, Ohio, United States, 44304
        • Recruiting
        • Summa Health System - Akron Campus
        • Principal Investigator:
          • Desiree E. Doncals
        • Contact:
      • Barberton, Ohio, United States, 44203
        • Recruiting
        • Summa Health System - Barberton Campus
        • Principal Investigator:
          • Desiree E. Doncals
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Dayssy A. Diaz Pardo
      • Medina, Ohio, United States, 44256
        • Recruiting
        • Summa Health Medina Medical Center
        • Principal Investigator:
          • Desiree E. Doncals
        • Contact:
      • Sylvania, Ohio, United States, 43560
        • Recruiting
        • ProMedica Flower Hospital
        • Contact:
        • Principal Investigator:
          • Eric P. Kielhorn
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Tyler Gunter
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Recruiting
        • Legacy Mount Hood Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2150
        • Principal Investigator:
          • Andrew Y. Kee
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Good Samaritan Hospital and Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-220-4937
          • Email: cancer@lhs.org
        • Principal Investigator:
          • Andrew Y. Kee
      • Tualatin, Oregon, United States, 97062
        • Recruiting
        • Legacy Meridian Park Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-1742
        • Principal Investigator:
          • Andrew Y. Kee
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Recruiting
        • Saint Luke's Cancer Center - Allentown
        • Contact:
          • Site Public Contact
          • Phone Number: 610-776-4714
        • Principal Investigator:
          • William H. Smith
      • Altoona, Pennsylvania, United States, 16601
        • Recruiting
        • UPMC Altoona
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Beaver, Pennsylvania, United States, 15009
        • Recruiting
        • UPMC-Heritage Valley Health System Beaver
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • Saint Luke's University Hospital-Bethlehem Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 484-503-4151
        • Principal Investigator:
          • William H. Smith
      • Broomall, Pennsylvania, United States, 19008
        • Recruiting
        • Crozer-Keystone Regional Cancer Center at Broomall
        • Contact:
        • Principal Investigator:
          • Rachelle M. Lanciano
      • Carlisle, Pennsylvania, United States, 17015
        • Recruiting
        • Carlisle Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Chadds Ford, Pennsylvania, United States, 19317
        • Recruiting
        • Christiana Care Health System-Concord Health Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Chambersburg, Pennsylvania, United States, 17201
        • Recruiting
        • Chambersburg Hospital
        • Contact:
        • Principal Investigator:
          • Sherif F. Yacoub
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Drexel Hill, Pennsylvania, United States, 19026
        • Recruiting
        • Delaware County Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Rachelle M. Lanciano
      • Easton, Pennsylvania, United States, 18045
        • Recruiting
        • Saint Luke's Hospital-Anderson Campus
        • Contact:
        • Principal Investigator:
          • William H. Smith
      • Ephrata, Pennsylvania, United States, 17522
        • Recruiting
        • Ephrata Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 717-721-4840
        • Principal Investigator:
          • Sherif F. Yacoub
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • UPMC Hillman Cancer Center Erie
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Erie, Pennsylvania, United States, 16544
        • Recruiting
        • Saint Vincent Hospital
        • Principal Investigator:
          • James A. Betler
        • Contact:
          • Site Public Contact
          • Phone Number: 814-452-5000
      • Farrell, Pennsylvania, United States, 16121
        • Recruiting
        • UPMC Cancer Center at UPMC Horizon
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Gettysburg, Pennsylvania, United States, 17325
        • Recruiting
        • Adams Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
        • Principal Investigator:
          • Sherif F. Yacoub
      • Glen Mills, Pennsylvania, United States, 19342
        • Recruiting
        • Crozer Regional Cancer Center at Brinton Lake
        • Contact:
          • Site Public Contact
          • Phone Number: 610-284-8237
        • Principal Investigator:
          • Rachelle M. Lanciano
      • Greensburg, Pennsylvania, United States, 15601
        • Recruiting
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Contact:
          • Site Public Contact
          • Phone Number: 724-838-1900
        • Principal Investigator:
          • Adam Olson
      • Harrisburg, Pennsylvania, United States, 17109
        • Recruiting
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Hershey, Pennsylvania, United States, 17033-0850
        • Recruiting
        • Penn State Milton S Hershey Medical Center
        • Principal Investigator:
          • Joseph A. Miccio
        • Contact:
      • Indiana, Pennsylvania, United States, 15701
        • Recruiting
        • IRMC Cancer Center
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Recruiting
        • Jefferson Hospital
        • Principal Investigator:
          • James A. Betler
        • Contact:
      • Johnstown, Pennsylvania, United States, 15901
        • Recruiting
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 814-534-4724
        • Principal Investigator:
          • Adam Olson
      • Lebanon, Pennsylvania, United States, 17042
        • Recruiting
        • Sechler Family Cancer Center
        • Contact:
        • Principal Investigator:
          • Sherif F. Yacoub
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • McKeesport, Pennsylvania, United States, 15132
        • Suspended
        • UPMC Cancer Center at UPMC McKeesport
      • Meadville, Pennsylvania, United States, 16335
        • Recruiting
        • Yolanda G Barco Oncology Institute
        • Principal Investigator:
          • James A. Betler
        • Contact:
      • Mechanicsburg, Pennsylvania, United States, 17050
        • Recruiting
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • Forbes Hospital
        • Principal Investigator:
          • James A. Betler
        • Contact:
          • Site Public Contact
          • Phone Number: 412-858-7746
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • UPMC Cancer Center - Monroeville
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Moon, Pennsylvania, United States, 15108
        • Recruiting
        • UPMC Hillman Cancer Center in Coraopolis
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Principal Investigator:
          • Adam C. Mueller
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
        • Principal Investigator:
          • Alvaro Pereira-Rico
        • Contact:
          • Site Public Contact
          • Phone Number: 215-728-2983
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
        • Principal Investigator:
          • Adam Olson
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC-Magee Womens Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-2811
        • Principal Investigator:
          • Adam Olson
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Hospital
        • Principal Investigator:
          • James A. Betler
        • Contact:
          • Site Public Contact
          • Phone Number: 412-578-5000
      • Pittsburgh, Pennsylvania, United States, 15215
        • Recruiting
        • UPMC-Saint Margaret
        • Contact:
          • Site Public Contact
          • Phone Number: 412-784-4900
        • Principal Investigator:
          • Adam Olson
      • Pittsburgh, Pennsylvania, United States, 15237
        • Recruiting
        • UPMC-Passavant Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-367-6454
        • Principal Investigator:
          • Adam Olson
      • Pittsburgh, Pennsylvania, United States, 15243
        • Recruiting
        • UPMC-Saint Clair Hospital Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 412-502-3920
        • Principal Investigator:
          • Adam Olson
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Principal Investigator:
          • James A. Betler
        • Contact:
          • Site Public Contact
          • Phone Number: 877-284-2000
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC-Shadyside Hospital
        • Principal Investigator:
          • Adam Olson
        • Contact:
          • Site Public Contact
          • Phone Number: 412-621-2334
      • Pottsville, Pennsylvania, United States, 17901
        • Recruiting
        • Geisinger Cancer Services-Pottsville
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Quakertown, Pennsylvania, United States, 18951
        • Recruiting
        • Saint Luke's Hospital-Quakertown Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 610-776-4714
        • Principal Investigator:
          • William H. Smith
      • Quakertown, Pennsylvania, United States, 18951
        • Recruiting
        • Saint Luke's Hospital - Upper Bucks Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 610-776-4714
        • Principal Investigator:
          • William H. Smith
      • Seneca, Pennsylvania, United States, 16346
        • Recruiting
        • UPMC Cancer Center at UPMC Northwest
        • Contact:
          • Site Public Contact
          • Phone Number: 814-676-7900
        • Principal Investigator:
          • Adam Olson
      • Stroudsburg, Pennsylvania, United States, 18360
        • Recruiting
        • Saint Luke's Hospital - Monroe Campus
        • Contact:
        • Principal Investigator:
          • William H. Smith
      • Uniontown, Pennsylvania, United States, 15401
        • Recruiting
        • UPMC Cancer Center-Uniontown
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Uniontown, Pennsylvania, United States, 15401
        • Recruiting
        • UPMC Uniontown Hospital Radiation Oncology
        • Contact:
          • Site Public Contact
          • Phone Number: 724-437-2503
        • Principal Investigator:
          • Adam Olson
      • Washington, Pennsylvania, United States, 15301
        • Recruiting
        • UPMC Cancer Center-Washington
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Washington, Pennsylvania, United States, 15301
        • Recruiting
        • UPMC Washington Hospital Radiation Oncology
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • West Chester, Pennsylvania, United States, 19380
        • Recruiting
        • Chester County Hospital
        • Principal Investigator:
          • Andre A. Konski
        • Contact:
          • Site Public Contact
          • Phone Number: 610-431-5297
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 610-988-9323
        • Principal Investigator:
          • Michael L. Haas
      • Wexford, Pennsylvania, United States, 15090
        • Recruiting
        • Wexford Health and Wellness Pavilion
        • Principal Investigator:
          • James A. Betler
        • Contact:
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Heath B. Mackley
      • Williamsport, Pennsylvania, United States, 17754
        • Recruiting
        • Divine Providence Hospital
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Willow Grove, Pennsylvania, United States, 19090
        • Suspended
        • Asplundh Cancer Pavilion
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health-York Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
        • Principal Investigator:
          • Sherif F. Yacoub
      • York, Pennsylvania, United States, 17408
        • Recruiting
        • UPMC Memorial
        • Contact:
          • Site Public Contact
          • Phone Number: 717-724-6760
        • Principal Investigator:
          • Adam Olson
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 401-444-1488
        • Principal Investigator:
          • Paul P. Koffer
      • Westerly, Rhode Island, United States, 02891
        • Recruiting
        • Smilow Cancer Hospital Care Center - Westerly
        • Principal Investigator:
          • Yi An
        • Contact:
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Recruiting
        • Saint Joseph's/Candler - Bluffton Campus
        • Contact:
        • Principal Investigator:
          • John A. Pablo
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • David T. Marshall
        • Contact:
      • Florence, South Carolina, United States, 29505
        • Suspended
        • MUSC Health Florence Medical Center
      • Greenville, South Carolina, United States, 29601
        • Recruiting
        • Saint Francis Hospital
        • Contact:
        • Principal Investigator:
          • Jennifer Vogel
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Saint Francis Cancer Center
        • Contact:
        • Principal Investigator:
          • Jennifer Vogel
      • Greenwood, South Carolina, United States, 29646
        • Recruiting
        • Self Regional Healthcare
        • Principal Investigator:
          • David T. Marshall
        • Contact:
      • Greer, South Carolina, United States, 29651
        • Recruiting
        • Gibbs Cancer Center-Pelham
        • Principal Investigator:
          • Drew C. Monitto
        • Contact:
      • Myrtle Beach, South Carolina, United States, 29577
        • Suspended
        • Carolina Regional Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Principal Investigator:
          • Drew C. Monitto
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Active, not recruiting
        • Thompson Cancer Survival Center
      • Maryville, Tennessee, United States, 37804
        • Active, not recruiting
        • Thompson Oncology Group-Maryville
      • Oak Ridge, Tennessee, United States, 37830
        • Active, not recruiting
        • Thompson Oncology Group-Oak Ridge
    • Texas
      • Baytown, Texas, United States, 77521
        • Recruiting
        • Houston Methodist San Jacinto Hospital
        • Principal Investigator:
          • Waqar Haque
        • Contact:
      • Conroe, Texas, United States, 77384
        • Suspended
        • MD Anderson in The Woodlands
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Principal Investigator:
          • Waqar Haque
        • Contact:
          • Site Public Contact
          • Phone Number: 713-790-2700
      • Houston, Texas, United States, 77070
        • Recruiting
        • Methodist Willowbrook Hospital
        • Principal Investigator:
          • Waqar Haque
        • Contact:
      • Houston, Texas, United States, 77030
        • Suspended
        • M D Anderson Cancer Center
      • Houston, Texas, United States, 77079
        • Suspended
        • MD Anderson West Houston
      • Houston, Texas, United States, 77094
        • Suspended
        • Houston Methodist West Hospital
      • Nassau Bay, Texas, United States, 77058
        • Recruiting
        • Houston Methodist Saint John Hospital
        • Principal Investigator:
          • Waqar Haque
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Christien Kluwe
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Houston Methodist Sugar Land Hospital
        • Principal Investigator:
          • Waqar Haque
        • Contact:
          • Site Public Contact
          • Phone Number: 281-242-2873
      • Sugar Land, Texas, United States, 77478
        • Suspended
        • MD Anderson in Sugar Land
      • The Woodlands, Texas, United States, 77385
        • Recruiting
        • Houston Methodist The Woodlands Hospital
        • Principal Investigator:
          • Waqar Haque
        • Contact:
    • Utah
      • American Fork, Utah, United States, 84003
        • Recruiting
        • American Fork Hospital / Huntsman Intermountain Cancer Center
        • Principal Investigator:
          • Brandon M. Barney
        • Contact:
      • Farmington, Utah, United States, 84025
        • Recruiting
        • Farmington Health Center
        • Principal Investigator:
          • Skyler B. Johnson
        • Contact:
      • Logan, Utah, United States, 84321
        • Recruiting
        • Logan Regional Hospital
        • Principal Investigator:
          • Brandon M. Barney
        • Contact:
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Principal Investigator:
          • Brandon M. Barney
        • Contact:
      • Ogden, Utah, United States, 84403
        • Recruiting
        • McKay-Dee Hospital Center
        • Principal Investigator:
          • Brandon M. Barney
        • Contact:
      • Provo, Utah, United States, 84604
        • Recruiting
        • Utah Valley Regional Medical Center
        • Principal Investigator:
          • Brandon M. Barney
        • Contact:
      • Riverton, Utah, United States, 84065
        • Recruiting
        • Riverton Hospital
        • Principal Investigator:
          • Brandon M. Barney
        • Contact:
      • Saint George, Utah, United States, 84770
        • Recruiting
        • Saint George Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Brandon M. Barney
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • University of Utah Sugarhouse Health Center
        • Principal Investigator:
          • Skyler B. Johnson
        • Contact:
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Principal Investigator:
          • Skyler B. Johnson
        • Contact:
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • Utah Cancer Specialists-Salt Lake City
        • Contact:
        • Principal Investigator:
          • Brandon M. Barney
      • Salt Lake City, Utah, United States, 84143
        • Recruiting
        • LDS Hospital
        • Principal Investigator:
          • Brandon M. Barney
        • Contact:
    • Vermont
      • Berlin, Vermont, United States, 05602
        • Recruiting
        • Central Vermont Medical Center/National Life Cancer Treatment
        • Principal Investigator:
          • Nataniel H. Lester-Coll
        • Contact:
          • Site Public Contact
          • Phone Number: 802-225-5400
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Principal Investigator:
          • Nataniel H. Lester-Coll
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-4101
          • Email: rpo@uvm.edu
      • Saint Johnsbury, Vermont, United States, 05819
        • Recruiting
        • Norris Cotton Cancer Center-North
        • Contact:
        • Principal Investigator:
          • Nirav S. Kapadia
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Recruiting
        • Inova Alexandria Hospital
        • Principal Investigator:
          • Eun-mi Yu
        • Contact:
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Principal Investigator:
          • Eun-mi Yu
        • Contact:
      • Fairfax, Virginia, United States, 22033
        • Recruiting
        • Inova Fair Oaks Hospital
        • Principal Investigator:
          • Eun-mi Yu
        • Contact:
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • William J. Irvin
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Contact:
        • Principal Investigator:
          • Alfredo I. Urdaneta
      • Richmond, Virginia, United States, 23230
        • Recruiting
        • Bon Secours Cancer Institute at Reynolds Crossing
        • Contact:
        • Principal Investigator:
          • William J. Irvin
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Oncology and Hematology Associates of Southwest Virginia
        • Contact:
        • Principal Investigator:
          • David A. Buck
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Medical Center
        • Principal Investigator:
          • Huong T. Pham
        • Contact:
      • Vancouver, Washington, United States, 98686
        • Recruiting
        • Legacy Salmon Creek Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2150
        • Principal Investigator:
          • Andrew Y. Kee
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Legacy Cancer Institute Medical Oncology and Day Treatment
        • Contact:
        • Principal Investigator:
          • Andrew Y. Kee
    • West Virginia
      • Wheeling, West Virginia, United States, 26003
        • Recruiting
        • Wheeling Hospital/Schiffler Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 304-243-6442
        • Principal Investigator:
          • Jondavid Pollock
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Langlade Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew J. Huang
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Principal Investigator:
          • Michael E. Ray
        • Contact:
      • Appleton, Wisconsin, United States, 54915
        • Recruiting
        • Ascension Saint Elizabeth Hospital
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Ashland, Wisconsin, United States, 54806
        • Recruiting
        • Northwest Wisconsin Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Brookfield, Wisconsin, United States, 53045
        • Recruiting
        • Ascension Southeast Wisconsin Hospital - Elmbrook Campus
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Burlington, Wisconsin, United States, 53105
        • Recruiting
        • Aurora Cancer Care-Southern Lakes VLCC
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Chilton, Wisconsin, United States, 53014
        • Recruiting
        • Ascension Calumet Hospital
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Eau Claire, Wisconsin, United States, 54701
        • Recruiting
        • HSHS Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Franklin, Wisconsin, United States, 53132
        • Recruiting
        • Ascension Saint Francis - Reiman Cancer Center
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Germantown, Wisconsin, United States, 53022
        • Recruiting
        • Aurora Health Care Germantown Health Center
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Grafton, Wisconsin, United States, 53024
        • Recruiting
        • Aurora Cancer Care-Grafton
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Green Bay, Wisconsin, United States, 54311
        • Recruiting
        • Aurora BayCare Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Kenosha, Wisconsin, United States, 53142
        • Recruiting
        • Aurora Cancer Care-Kenosha South
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Mayo Clinic Health System-Franciscan Healthcare
        • Principal Investigator:
          • Bradley J. Stish
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Marinette, Wisconsin, United States, 54143
        • Recruiting
        • Aurora Bay Area Medical Group-Marinette
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Menomonee Falls, Wisconsin, United States, 53051
        • Recruiting
        • Froedtert Menomonee Falls Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 262-257-5100
        • Principal Investigator:
          • Michael W. Straza
      • Mequon, Wisconsin, United States, 53097
        • Recruiting
        • Ascension Columbia Saint Mary's Hospital Ozaukee
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Milwaukee, Wisconsin, United States, 53209
        • Recruiting
        • Aurora Cancer Care-Milwaukee
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Saint Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • Michael W. Straza
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Aurora Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Milwaukee, Wisconsin, United States, 53211
        • Recruiting
        • Ascension Columbia Saint Mary's Hospital - Milwaukee
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Milwaukee, Wisconsin, United States, 53295
        • Recruiting
        • Zablocki Veterans Administration Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-469-6614
        • Principal Investigator:
          • Elizabeth M. Gore
      • Oak Creek, Wisconsin, United States, 53154
        • Recruiting
        • Drexel Town Square Health Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Michael W. Straza
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Vince Lombardi Cancer Clinic - Oshkosh
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Ascension Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Racine, Wisconsin, United States, 53406
        • Recruiting
        • Aurora Cancer Care-Racine
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Racine, Wisconsin, United States, 53405
        • Recruiting
        • Ascension All Saints Hospital
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • Rhinelander, Wisconsin, United States, 54501
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Stevens Point, Wisconsin, United States, 54481
        • Recruiting
        • Ascension Saint Michael's Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Summit, Wisconsin, United States, 53066
        • Recruiting
        • Aurora Medical Center in Summit
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Two Rivers, Wisconsin, United States, 54241
        • Recruiting
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Aurora Cancer Care-Milwaukee West
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Ascension Medical Group Southeast Wisconsin - Mayfair Road
        • Contact:
        • Principal Investigator:
          • Shannon Offerman
      • West Allis, Wisconsin, United States, 53227
        • Recruiting
        • Aurora West Allis Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • West Bend, Wisconsin, United States, 53095
        • Recruiting
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Michael W. Straza
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Recruiting
        • Aspirus Cancer Care - Wisconsin Rapids
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 715-422-7718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PRIOR TO STEP 1 REGISTRATION
  • Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration

  • High-risk disease defined as having at least one or more of the following:

    • PSA > 20 ng/mL prior to starting ADT Note: Patients receiving a 5-alpha reductase inhibitor (ex. finasteride) at the time of enrollment are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors and the medication should be discontinued prior to randomization but a washout period is not required.
    • cT3a-T4 by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.])
    • Gleason score of 8-10
    • Node positive by conventional imaging with a short axis of at least 1.0 cm

  • Appropriate stage for study entry based on the following diagnostic workup:

    • History/physical examination within 120 days prior to registration;

    • Bone imaging within 120 days prior to registration;

      • Note: To be eligible, patient must have no definitive evidence of bone metastases (M0) on bone scan or sodium fluoride (NaF) PET within 120 days prior to registration (negative NaF PET/CT or negative Axumin or choline PET or negative fluciclovine, choline or prostate-specific membrane antigen (PSMA) PET within 120 days prior to registration is an acceptable substitute if they have been performed). Patients who have bone metastases established only fluciclovine, choline, or PSMA PET but not definitive on bone scan or NaF PET will still be eligible
    • CT or MRI of the pelvis within 120 days prior to registration (negative fluciclovine, choline, or PSMA PET within 120 days prior to registration is an acceptable substitute). As with bone staging, nodal staging for trial purposes will be based off of conventional imaging findings only
    • Patients with confirmed N1 metastases on conventional imaging (CT/MRI) as defined by ≥10 mm on short axis are eligible but will be automatically assigned to the intensification study. Patients who are positive by fluciclovine, choline, or PSMA PET (i.e. N1), but whose nodes do not meet traditional size criteria for positivity (i.e. they measure ≥ 10 mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 for the trial and will not automatically be assigned to the intensification study
  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
  • Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
  • Platelet count ≥ -100 x 10^3/uL independent of transfusion and/or growth factors (within 120 days prior to registration)

  • Creatinine clearance (CrCl) ≥ 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)

    • For Black patients whose renal function is not considered adequate by Cockcroft-Gault formula, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) may be used for calculating creatinine clearance for trial eligibility
    • Either a CrCl ≥ 30 ml/min or calculated glomerular filtration rate (GFR) ≥ 30 will make a patient eligible

  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 120 days prior to registration)

    • Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject is eligible
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (within 120 days prior to registration)
  • Serum albumin ≥ 3.0 g/dL (within 120 days prior to registration)
  • The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count ≥ 200 cells/microliter within 60 days prior to registration. Note: HIV testing is not required for eligibility for this protocol. Of note, for patients with HIV in the intensification trial randomized to apalutamide, highly active antiretroviral therapy (HAART) may need to be adjusted to medications that do not interact with apalutamide
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable after or on suppressive therapy within 60 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the principal investigator
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • PRIOR TO STEP 2 RANDOMIZATION
  • Confirmation of Decipher score
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 60 days prior. Note: Apalutamide may interfere with HCV drugs. Patients on HCV medications should alert their infectious diseases physician if they get randomized to apalutamide due to the possibility that apalutamide can affect the bioavailability of some HCV medications. HCV viral testing is not required for eligibility for this protocol
  • For patients entering the Intensification Cohort ONLY: Patients must discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to Step 2 randomization

Exclusion Criteria:

  • PRIOR TO STEP 1 REGISTRATION:
  • Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI)
  • Prior systemic chemotherapy within ≤ 3 years prior to registration; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration
  • Prior radical prostatectomy
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Current use of 5-alpha reductase inhibitor. NOTE: If the alpha reductase inhibitor is stopped prior to randomization the patient is eligible

  • History of any of the following:

    • Seizure disorder
    • Current severe or unstable angina
    • New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
    • History of any condition that in the opinion of the investigator, would preclude participation in this study

  • Evidence of any of the following at registration:

    • Active uncontrolled infection requiring IV antibiotics
    • Baseline severe hepatic impairment (Child Pugh Class C)
    • Inability to swallow oral pills
    • Any current condition that in the opinion of the investigator, would preclude participation in this study
  • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone-releasing hormone [LHRH] agonist and oral anti-androgen) is ≤ 60 days prior to registration; Please note: baseline PSA must be obtained prior to the start of any ADT
  • PRIOR TO STEP 2 RANDOMIZATION:
  • Evidence of known gastrointestinal disorder affecting absorption of oral medications at registration
  • For patients entering the Intensification Cohort ONLY: Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] ≥ 160 mmHg or diastolic BP ≥ 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (de-intensification study)
Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
Drug: Bicalutamide
Antiandrogen
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334
Drug: Buserelin
Luteinizing hormone-releasing hormone (LHRH) agonist
Other Names:
  • 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig)
  • BSRL
  • Busereline
  • Etilamide
  • HOE 766
  • ICI 123215
  • S74-6766
Drug: Degarelix
Gonadotropin-releasing hormone (GnRH) antagonist
Other Names:
  • Firmagon
  • FE200486
Drug: Flutamide
Antiandrogen
Other Names:
  • Apimid
  • Cebatrol
  • Chimax
  • Cytomid
  • Drogenil
  • Euflex
  • Eulexine
  • Flucinom
  • Flucinome
  • Flugerel
  • Fluken
  • Flulem
  • FLUT
  • Fluta-Gry
  • Flutabene
  • Flutacan
  • Flutamex
  • Flutamin
  • Flutan
  • Flutaplex
  • Fugerel
  • Grisetin
  • Niftolide
  • Oncosal
  • Profamid
  • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
  • Prostacur
  • Prostadirex
  • Prostica
  • Prostogenat
  • Sch 13521
  • Tafenil
  • Tecnoflut
  • Testotard
  • 4'-Nitro-3'-trifluoromethylisobutyranilide
Drug: Goserelin
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • ICI-118630
Drug: Histrelin
Gonadotropin-releasing hormone (GnRH) agonist
Drug: Leuprolide
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • Leuprorelin
Drug: Triptorelin
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Experimental: Arm II (de-intensification study)
Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 12 months in the absence of disease progression or unacceptable toxicity.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
Drug: Bicalutamide
Antiandrogen
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334
Drug: Buserelin
Luteinizing hormone-releasing hormone (LHRH) agonist
Other Names:
  • 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig)
  • BSRL
  • Busereline
  • Etilamide
  • HOE 766
  • ICI 123215
  • S74-6766
Drug: Degarelix
Gonadotropin-releasing hormone (GnRH) antagonist
Other Names:
  • Firmagon
  • FE200486
Drug: Flutamide
Antiandrogen
Other Names:
  • Apimid
  • Cebatrol
  • Chimax
  • Cytomid
  • Drogenil
  • Euflex
  • Eulexine
  • Flucinom
  • Flucinome
  • Flugerel
  • Fluken
  • Flulem
  • FLUT
  • Fluta-Gry
  • Flutabene
  • Flutacan
  • Flutamex
  • Flutamin
  • Flutan
  • Flutaplex
  • Fugerel
  • Grisetin
  • Niftolide
  • Oncosal
  • Profamid
  • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
  • Prostacur
  • Prostadirex
  • Prostica
  • Prostogenat
  • Sch 13521
  • Tafenil
  • Tecnoflut
  • Testotard
  • 4'-Nitro-3'-trifluoromethylisobutyranilide
Drug: Goserelin
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • ICI-118630
Drug: Histrelin
Gonadotropin-releasing hormone (GnRH) agonist
Drug: Leuprolide
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • Leuprorelin
Drug: Triptorelin
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Active Comparator: Arm III (intensification study)
Patients undergo RT over 2-11 weeks and receive ADT as in Arm I.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
Drug: Bicalutamide
Antiandrogen
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334
Drug: Buserelin
Luteinizing hormone-releasing hormone (LHRH) agonist
Other Names:
  • 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig)
  • BSRL
  • Busereline
  • Etilamide
  • HOE 766
  • ICI 123215
  • S74-6766
Drug: Degarelix
Gonadotropin-releasing hormone (GnRH) antagonist
Other Names:
  • Firmagon
  • FE200486
Drug: Flutamide
Antiandrogen
Other Names:
  • Apimid
  • Cebatrol
  • Chimax
  • Cytomid
  • Drogenil
  • Euflex
  • Eulexine
  • Flucinom
  • Flucinome
  • Flugerel
  • Fluken
  • Flulem
  • FLUT
  • Fluta-Gry
  • Flutabene
  • Flutacan
  • Flutamex
  • Flutamin
  • Flutan
  • Flutaplex
  • Fugerel
  • Grisetin
  • Niftolide
  • Oncosal
  • Profamid
  • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
  • Prostacur
  • Prostadirex
  • Prostica
  • Prostogenat
  • Sch 13521
  • Tafenil
  • Tecnoflut
  • Testotard
  • 4'-Nitro-3'-trifluoromethylisobutyranilide
Drug: Goserelin
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • ICI-118630
Drug: Histrelin
Gonadotropin-releasing hormone (GnRH) agonist
Drug: Leuprolide
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • Leuprorelin
Drug: Triptorelin
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Experimental: Arm IV (intensification study)
Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin) for 24 months in the absence of disease progression or unacceptable toxicity. Patients also receive apalutamide PO QD. Treatment repeats every 90 days for up to 8 cycles (24 months) in the absence of disease progression or unacceptable toxicity.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
Drug: Buserelin
Luteinizing hormone-releasing hormone (LHRH) agonist
Other Names:
  • 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig)
  • BSRL
  • Busereline
  • Etilamide
  • HOE 766
  • ICI 123215
  • S74-6766
Drug: Degarelix
Gonadotropin-releasing hormone (GnRH) antagonist
Other Names:
  • Firmagon
  • FE200486
Drug: Goserelin
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • ICI-118630
Drug: Histrelin
Gonadotropin-releasing hormone (GnRH) agonist
Drug: Leuprolide
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • Leuprorelin
Drug: Triptorelin
Gonadotropin-releasing hormone (GnRH) agonist
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Drug: Apalutamide
Nonsteroidal Antiandrogen
Other Names:
  • ARN-509
  • JNJ-56021927
  • ARN 509
  • ARN509
  • Erleada
  • JNJ 56021927

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastasis-free survival (MFS)
Time Frame: From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years
Assessed based on conventional imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958).
From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MFS
Time Frame: From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years
Assessed based on standard or molecular, if available, imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958)
From randomization to the date of detection of distant metastasis on standard imaging or date of death from any cause, assessed up to 13 years
Overall survival
Time Frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 13 years
Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test (Kaplan 1958).
From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 13 years
Prostate cancer specific mortality (PCSM)
Time Frame: From the date of randomization to the date of prostate cancer death, assessed up to 13 years
From the date of randomization to the date of prostate cancer death, assessed up to 13 years
Prostate specific antigen (PSA) failure-free survival with non-castrate testosterone and no additional therapies
Time Frame: From the date of randomization to the date event, or death or censored at the last known follow-up date, assessed up to 13 years
PSA failure-free survival will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test (Kaplan 1958).
From the date of randomization to the date event, or death or censored at the last known follow-up date, assessed up to 13 years
Time to testosterone recovery
Time Frame: Up to 13 years
Defined as testosterone that is non-castrate.
Up to 13 years
Time to PSA failure or salvage therapy
Time Frame: Up to 13 years
Up to 13 years
Testosterone levels at the time of PSA failure and metastases
Time Frame: Up to 13 years
Up to 13 years
Incidence of adverse events
Time Frame: Up to 13 years
Measured by the Common Terminology Criteria for Adverse Events (CTCAE ) version (v) 5.0 and Patient Reported Outcomes (PRO)-CTCAE.
Up to 13 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardio-metabolic markers including body mass index and waist circumference
Time Frame: Up to 13 years
Up to 13 years
Machine learning/artificial intelligence algorithm
Time Frame: Up to 13 years
Up to 13 years
Bowel and urinary quality of life (De-intensification study)
Time Frame: Up to 13 years
Measured by EPIC-26 bowel and urinary domains.
Up to 13 years
Cognition (De-intensification study)
Time Frame: Up to 13 years
Measured by the Functional Assessment of Chronic Illness Therapy-Cognition (FACIT-Cog) perceived cognitive abilities subscale.
Up to 13 years
Sexual, hormonal, bowel, and urinary quality of life (Intensification study)
Time Frame: Up to 13 years
Measured by Expanded Prostate Cancer Index Composite-26.
Up to 13 years
Cognition (Intensification study)
Time Frame: Up to 13 years
Measured by the FACIT-Cog perceived cognitive abilities subscale.
Up to 13 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NRG Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Paul L Nguyen, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRG-GU009 (Other Identifier: CTEP)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NCI-2020-04705 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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