Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

April 18, 2024 updated by: ECOG-ACRIN Cancer Research Group

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen [PSA] after surgical removal of the prostate cancer).

A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested.

Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. For patients without PET-evidence of extrapelvic metastases, to evaluate whether the addition of enhanced systemic therapy to standard of care (SOC) salvage radiation therapy (RT) could prolong progression-free survival (PFS).

II. For patients with PET-evidence of extrapelvic metastases, to evaluate whether the addition of metastasis-directed RT to enhanced systemic therapy and SOC salvage RT could prolong PFS.

III. To compare overall quality of life, measured by Functional Assessment of Cancer Therapy - Prostate (FACT-P) total score, at 6 months between the two sets of treatment arms (A with B and C with D). (QUALITY OF LIFE [QOL] OBJECTIVE)

SECONDARY OBJECTIVES:

I. To evaluate overall survival in each arm. II. To evaluate event-free survival in each arm. III. To evaluate time to prostate-specific antigen (PSA) progression in each arm.

IV. To assess the incidence of adverse events with the addition of enhanced systemic therapy in patients without PET-evidence of extrapelvic metastases.

V. To assess the incidence of adverse events with local ablative metastasis-directed RT for PET-positive metastatic disease in patients with PET-evidence of extrapelvic metastases.

VI. To estimate the detection rate of PET at the patient and regional level, and to evaluate its concordance with the follow-up Food and Drug Administration (FDA)-approved conventional imaging modalities (CIM) (as available) considered standard-of-care per institution, including computed tomography (CT), bone scintigraphy, magnetic resonance imaging (MRI) and PET imaging.

VII. To determine the distribution of PET-positive lesions among anatomic sites (prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases) in patients with post-radical prostatectomy (RP) biochemical recurrence (BCR), correlated with PSA (level, doubling time, velocity) and other relevant clinical parameters.

VIII. To compare the change in overall QOL, measured by FACT-P total score, from baseline to 6 months between the two sets of treatment arms (A with B and C with D). (QOL OBJECTIVE) IX. To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scores) at 6 months between the two sets of treatment arms (A with B and C with D). (QOL OBJECTIVE) X. To compare patient-reported overall QOL (FACT-P scores), fatigue (FACIT-Fatigue scores) and pain interference (patient reported outcomes measurement information system [PROMIS] Pain Interference Short Form 4a) between the two sets of treatment arms (A with B and C with D) at the time of disease progression. (QOL OBJECTIVE)

EXPLORATORY OBJECTIVES:

I.To determine the value of repeat PET (PET2) at time of second PSA progression, clinical concern for progression, or 12 months after completion of enhanced systemic therapy, whichever comes first to assess response to therapy (enhanced systemic therapy +/- focal RT and/or androgen deprivation therapy [ADT]) compared to available standard response assessments (PSA and conventional imaging modalities [CIM]).

II. To compare cognitive function, measured by FACT - cognitive function (Cog) peritoneal cancer index (PCI) and total scores, between the three treatment arms receiving enhanced systemic treatment with ADT and apalutamide (Arms B, C, and D) and antiandrogen therapy (ADT) alone (Arm A) at 6 and 12 month. (QOL OBJECTIVE) III. To compare the change in cognitive function, measured by change in FACT-Cog PCI and total scores, from baseline to 6 and baseline to 12 months, between the three treatment arms receiving enhanced systemic treatment with ADT and apalutamide (Arms B, C, and D) and ADT alone (Arm A) at 6 and 12 months. (QOL OBJECTIVE) IV. To characterize longitudinal change in cognitive function between baseline and 24 months in patients with prostate cancer receiving treatment for biochemical recurrence (BCR) and define clinical and disease related characteristics associated with greater cognitive change by the FACT-Cog PCI and total scores. (QOL OBJECTIVE)

OUTLINE:

STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 intravenously (IV) undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.

STEP 1: Patients are randomized to 1 of 4 arms based on results of fluciclovine F18 PET/CT or PET/MR in Step 0.

ARM A (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC external beam radiation therapy (EBRT) for 6 months. Patients also receive goserelin acetate subcutaneously (SC), leuprolide acetate intramuscularly (IM), triptorelin IM, relugolix orally (PO), or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.

ARM B (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO once daily (QD) for 6 months in the absence of disease progression or unacceptable toxicity.

ARM C: (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B.

ARM D (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo stereotactic body radiation therapy (SBRT) or 3-dimensional (3D) conformal radiation therapy (CRT), intensity-modulated radiation therapy (IMRT) (including volume modulated arc therapy [VMAT]), and intensity-modulated proton therapy (IMPT) over 3-10 fractions in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for the first 2 years, every 6 months for years 3-5, and then annually for years 6-10.

Study Type

Interventional

Enrollment (Estimated)

804

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

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 98508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Phoenix, Arizona, United States, 85004
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
    • California
      • Arroyo Grande, California, United States, 93420
      • Burbank, California, United States, 91505
        • Recruiting
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Carmichael, California, United States, 95608
        • Recruiting
        • Mercy Cancer Center �� Carmichael
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Carmichael, California, United States, 95608
        • Recruiting
        • Mercy San Juan Medical Center
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Corona, California, United States, 92879
        • Recruiting
        • City of Hope Corona
        • Contact:
        • Principal Investigator:
          • Scott M. Glaser
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Principal Investigator:
          • Scott M. Glaser
        • Contact:
      • Elk Grove, California, United States, 95758
        • Recruiting
        • Mercy Cancer Center - Elk Grove
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • James M. Randall
        • Contact:
      • Lancaster, California, United States, 93534
        • Recruiting
        • City of Hope Antelope Valley
        • Contact:
        • Principal Investigator:
          • Scott M. Glaser
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA / Jonsson Comprehensive Cancer Center
        • Principal Investigator:
          • Amar Kishan
        • Contact:
          • Site Public Contact
          • Phone Number: 888-798-0719
      • 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
      • Merced, California, United States, 95340
      • Rocklin, California, United States, 95765
        • Recruiting
        • Mercy Cancer Center - Rocklin
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Sacramento, California, United States, 95816
        • Recruiting
        • Mercy Cancer Center - Sacramento
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • San Luis Obispo, California, United States, 93401
      • Santa Maria, California, United States, 93444
      • South Pasadena, California, United States, 91030
        • Recruiting
        • City of Hope South Pasadena
        • Contact:
        • Principal Investigator:
          • Scott M. Glaser
      • Woodland, California, United States, 95695
        • Recruiting
        • Woodland Memorial Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Penrose-Saint Francis Healthcare
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Rocky Mountain Cancer Centers-Penrose
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Colorado Springs, Colorado, United States, 80923
        • Recruiting
        • Saint Francis Cancer Center
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Denver, Colorado, United States, 80210
        • Suspended
        • Porter Adventist Hospital
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Saint Anthony Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Littleton, Colorado, United States, 80122
        • Suspended
        • Littleton Adventist Hospital
      • Longmont, Colorado, United States, 80501
        • Recruiting
        • Longmont United Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Parker, Colorado, United States, 80138
        • Suspended
        • Parker Adventist Hospital
      • Pueblo, Colorado, United States, 81004
        • Recruiting
        • Saint Mary Corwin Medical Center
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Recruiting
        • Sibley Memorial Hospital
        • Principal Investigator:
          • Curtiland Deville
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Idaho Urologic Institute-Meridian
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, United States, 83686
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Recruiting
        • Saint Luke's Cancer Institute - Twin Falls
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • 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
      • Carbondale, Illinois, United States, 62902
        • Recruiting
        • Memorial Hospital of Carbondale
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carterville, Illinois, United States, 62918
        • Recruiting
        • SIH Cancer Institute
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Saint Mary's Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Sean Sachdev
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Principal Investigator:
          • Daniel Moreira
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • William F. Hartsell
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • 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
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Western Illinois Cancer Treatment Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 309-344-2831
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • William F. Hartsell
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • 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
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Maywood, Illinois, United States, 60153
        • Active, not recruiting
        • Loyola University Medical Center
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • Good Samaritan Regional Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-242-4600
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • HSHS Saint Elizabeth's Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • 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
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Valley Radiation Oncology
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-664-4141
      • 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
        • Contact:
        • Principal Investigator:
          • Fahrettin Covut
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Memorial Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • The Carle Foundation Hospital
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • William F. Hartsell
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Great Bend, Kansas, United States, 67530
        • Recruiting
        • Central Care Cancer Center - Great Bend
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40509
      • Lexington, Kentucky, United States, 40504
      • Lexington, Kentucky, United States, 40504
        • Recruiting
        • Saint Joseph Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Louisville, Kentucky, United States, 40202
        • Suspended
        • Jewish Hospital
    • Maine
      • Bath, Maine, United States, 04530
        • Active, not recruiting
        • MaineHealth Coastal Cancer Treatment Center
      • Biddeford, Maine, United States, 04005
        • Active, not recruiting
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
      • Portland, Maine, United States, 04102
        • Active, not recruiting
        • Maine Medical Center-Bramhall Campus
      • Sanford, Maine, United States, 04073
        • Active, not recruiting
        • MaineHealth Cancer Care Center of York County
      • Sanford, Maine, United States, 04073
        • Active, not recruiting
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
      • Scarborough, Maine, United States, 04074
        • Active, not recruiting
        • Maine Medical Center- Scarborough Campus
      • South Portland, Maine, United States, 04106
        • Active, not recruiting
        • Maine Medical Partners - South Portland
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Principal Investigator:
          • Curtiland Deville
        • Contact:
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland/Greenebaum Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-888-8823
        • Principal Investigator:
          • Mark V. Mishra
      • Bethesda, Maryland, United States, 20814
        • Recruiting
        • Suburban Hospital
        • Contact:
        • Principal Investigator:
          • Curtiland Deville
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • UM Baltimore Washington Medical Center/Tate Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 410-553-8100
        • Principal Investigator:
          • Mark V. Mishra
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Contact:
        • Principal Investigator:
          • David M. King
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Fridley, Minnesota, United States, 55432
        • Active, not recruiting
        • Unity Hospital
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • Health Partners Inc
        • Contact:
        • Principal Investigator:
          • David M. King
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contact:
        • Principal Investigator:
          • Donald J. Jurgens
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • David M. King
    • Mississippi
      • Grenada, Mississippi, United States, 38901
        • Recruiting
        • Baptist Cancer Center-Grenada
        • Contact:
        • Principal Investigator:
          • Andrew J. Benefield
      • Jackson, Mississippi, United States, 39216
        • Active, not recruiting
        • University of Mississippi Medical Center
      • New Albany, Mississippi, United States, 38652
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Union County
        • Contact:
        • Principal Investigator:
          • Andrew J. Benefield
      • Oxford, Mississippi, United States, 38655
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Oxford
        • Contact:
        • Principal Investigator:
          • Andrew J. Benefield
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Central Care Cancer Center - Bolivar
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • 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
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Southeast Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-651-5550
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Jeff M. Michalski
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Jefferson City, Missouri, United States, 65109
        • Recruiting
        • Capital Region Southwest Campus
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Delbert Day Cancer Institute at PCRMC
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • 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, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • 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 Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Jeff M. Michalski
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • BJC Outpatient Center at Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Great Falls Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Kalispell Regional Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Saint Patrick Hospital - Community Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Nebraska
      • Kearney, Nebraska, United States, 68847
      • Omaha, Nebraska, United States, 68122
      • Omaha, Nebraska, United States, 68124
      • Omaha, Nebraska, United States, 68130
      • Omaha, Nebraska, United States, 68131
    • 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
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 201-996-2879
        • Principal Investigator:
          • Robert S. Alter
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • Tina Mayer
      • Somerville, New Jersey, United States, 08876
        • Recruiting
        • Robert Wood Johnson University Hospital Somerset
        • Contact:
        • Principal Investigator:
          • Tina Mayer
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Community Medical Center
        • Contact:
        • Principal Investigator:
          • Tina Mayer
      • 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 York
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • Northwell Health Imbert Cancer Center
        • Principal Investigator:
          • Michael R. Folkert
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Einstein Campus
        • Contact:
        • Principal Investigator:
          • Benjamin A. Gartrell
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Contact:
        • Principal Investigator:
          • Benjamin A. Gartrell
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Weiler Hospital
        • Contact:
        • Principal Investigator:
          • Benjamin A. Gartrell
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/Center for Advanced Medicine
        • Principal Investigator:
          • Michael R. Folkert
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
      • New York, New York, United States, 10011
        • Recruiting
        • Mount Sinai Chelsea
        • Principal Investigator:
          • Bobby Liaw
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Principal Investigator:
          • Bobby Liaw
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
      • New York, New York, United States, 10021
        • Recruiting
        • Lenox Hill Hospital
        • Principal Investigator:
          • Michael R. Folkert
        • 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:
          • Michael R. Folkert
        • Contact:
          • Site Public Contact
          • Phone Number: 212-434-4460
      • New York, New York, United States, 10019
        • Recruiting
        • Mount Sinai West
        • Principal Investigator:
          • Bobby Liaw
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
      • New York, New York, United States, 10003
        • Recruiting
        • Mount Sinai Union Square
        • Principal Investigator:
          • Bobby Liaw
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
      • Sleepy Hollow, New York, United States, 10591
        • Recruiting
        • Phelps Memorial Hospital Center
        • Principal Investigator:
          • Michael R. Folkert
        • 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
    • North Carolina
      • Kenansville, North Carolina, United States, 28349
        • Recruiting
        • Vidant Oncology-Kenansville
        • Contact:
        • Principal Investigator:
          • Misbah U. Qadir
      • Kinston, North Carolina, United States, 28501
        • Recruiting
        • Vidant Oncology-Kinston
        • Contact:
        • Principal Investigator:
          • Misbah U. Qadir
      • Richlands, North Carolina, United States, 28574
        • Recruiting
        • Vidant Oncology-Richlands
        • Contact:
        • Principal Investigator:
          • Misbah U. Qadir
    • Ohio
      • Cincinnati, Ohio, United States, 45220
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45219
        • Active, not recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Shang-Jui Wang
      • West Chester, Ohio, United States, 45069
        • Active, not recruiting
        • University of Cincinnati Cancer Center-West Chester
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Tyler Gunter
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Saint Charles Health System
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Providence Cancer Institute Clackamas Clinic
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Coos Bay, Oregon, United States, 97420
        • Recruiting
        • Bay Area Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Gresham, Oregon, United States, 97030
        • Active, not recruiting
        • Legacy Mount Hood Medical Center
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Arthur Y. Hung
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97210
        • Active, not recruiting
        • Legacy Good Samaritan Hospital and Medical Center
      • Tualatin, Oregon, United States, 97062
        • Active, not recruiting
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
      • Beaver, Pennsylvania, United States, 15009
        • Recruiting
        • UPMC-Heritage Valley Health System Beaver
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • 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
      • Drexel Hill, Pennsylvania, United States, 19026
        • Recruiting
        • Delaware County Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Rachelle M. Lanciano
      • East Norriton, Pennsylvania, United States, 19401
        • Recruiting
        • Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
        • Contact:
        • Principal Investigator:
          • Mark A. Hallman
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • UPMC Hillman Cancer Center Erie
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Farrell, Pennsylvania, United States, 16121
        • Recruiting
        • UPMC Cancer Center at UPMC Horizon
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Furlong, Pennsylvania, United States, 18925
        • Recruiting
        • Fox Chase Cancer Center Buckingham
        • Contact:
          • Site Public Contact
          • Phone Number: 215-794-2700
        • Principal Investigator:
          • Mark A. Hallman
      • 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:
      • 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
      • 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
        • 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
      • Natrona Heights, Pennsylvania, United States, 15065
        • Recruiting
        • UPMC Cancer Center-Natrona Heights
        • Contact:
          • Site Public Contact
          • Phone Number: 724-230-3030
        • Principal Investigator:
          • Adam Olson
      • New Castle, Pennsylvania, United States, 16105
        • Recruiting
        • UPMC Hillman Cancer Center - New Castle
        • 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, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 215-728-4790
        • Principal Investigator:
          • Mark A. Hallman
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 215-728-2983
        • Principal Investigator:
          • Mark A. Hallman
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania /Abramson Cancer Center/ University of Pennsylvania
        • Principal Investigator:
          • Neha Vapiwala
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn Presbyterian Medical Center /Abramson Cancer Center/ University of Pennsylvania
        • Principal Investigator:
          • Neha Vapiwala
        • Contact:
      • 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, 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, 15232
        • Recruiting
        • UPMC-Shadyside Hospital
        • Principal Investigator:
          • Adam Olson
        • Contact:
          • Site Public Contact
          • Phone Number: 412-621-2334
      • 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
      • 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 Washington Hospital Radiation Oncology
        • Contact:
        • Principal Investigator:
          • Adam Olson
      • Williamsport, Pennsylvania, United States, 17701
        • Recruiting
        • UPMC Susquehanna
        • Contact:
          • Site Public Contact
          • Phone Number: 800-598-4282
        • Principal Investigator:
          • Adam Olson
      • York, Pennsylvania, United States, 17408
        • Recruiting
        • UPMC Memorial
        • Contact:
          • Site Public Contact
          • Phone Number: 717-724-6760
        • Principal Investigator:
          • Adam Olson
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Harriet B. Eldredge-Hindy
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Kevin D. Courtney
      • Dallas, Texas, United States, 75237
        • Recruiting
        • UT Southwestern Simmons Cancer Center - RedBird
        • Contact:
        • Principal Investigator:
          • Kevin D. Courtney
      • Fort Worth, Texas, United States, 76104
        • Not yet recruiting
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Contact:
        • Principal Investigator:
          • Kevin D. Courtney
      • Richardson, Texas, United States, 75080
        • Recruiting
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contact:
        • Principal Investigator:
          • Kevin D. Courtney
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Audie L Murphy VA Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 877-469-5300
        • Principal Investigator:
          • Michael A. Liss
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Contact:
        • Principal Investigator:
          • Alfredo I. Urdaneta
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Recruiting
        • Providence Regional Cancer System-Aberdeen
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • PeaceHealth Saint Joseph Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 360-788-8223
        • Principal Investigator:
          • Alison K. Conlin
      • Bremerton, Washington, United States, 98310
      • Centralia, Washington, United States, 98531
        • Recruiting
        • Providence Regional Cancer System-Centralia
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Everett, Washington, United States, 98201
        • Recruiting
        • Providence Regional Cancer Partnership
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Lacey, Washington, United States, 98503
        • Recruiting
        • Providence Regional Cancer System-Lacey
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Longview, Washington, United States, 98632
        • Recruiting
        • PeaceHealth Saint John Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98107
        • Recruiting
        • Swedish Medical Center-Ballard Campus
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98109
        • Recruiting
        • FHCC South Lake Union
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Jonathan J. Chen
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Jonathan J. Chen
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center - Montlake
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Jonathan J. Chen
      • Seattle, Washington, United States, 98133
        • Recruiting
        • FHCC at Northwest Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 206-606-5800
        • Principal Investigator:
          • Jonathan J. Chen
      • Sedro-Woolley, Washington, United States, 98284
        • Recruiting
        • PeaceHealth United General Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Vancouver, Washington, United States, 98686
        • Active, not recruiting
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, United States, 98684
        • Active, not recruiting
        • Legacy Cancer Institute Medical Oncology and Day Treatment
      • Walla Walla, Washington, United States, 99362
        • Recruiting
        • Providence Saint Mary Regional Cancer Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Langlade Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew J. Huang
      • Eau Claire, Wisconsin, United States, 54701
      • Johnson Creek, Wisconsin, United States, 53038
        • Recruiting
        • UW Cancer Center Johnson Creek
        • Principal Investigator:
          • John M. Floberg
        • Contact:
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Principal Investigator:
          • John M. Floberg
        • Contact:
          • Site Public Contact
          • Phone Number: 800-622-8922
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • William S Middleton VA Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 17007 608-256-1901
        • Principal Investigator:
          • Jessica M. Schuster
      • Marshfield, Wisconsin, United States, 54449
      • Minocqua, Wisconsin, United States, 54548
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • David M. King
      • Rhinelander, Wisconsin, United States, 54501
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Rice Lake, Wisconsin, United States, 54868
      • Stevens Point, Wisconsin, United States, 54482
      • Stevens Point, Wisconsin, United States, 54481
        • Recruiting
        • Ascension Saint Michael's Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
      • Weston, Wisconsin, United States, 54476
      • 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
    • Wyoming
      • Sheridan, Wyoming, United States, 82801
        • Recruiting
        • Welch Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:

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:

  • STEP 0: REGISTRATION ELIGIBILITY CRITERIA
  • Patient must be male and >= 18 years of age.
  • Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma

  • Patient must have biochemical recurrence (BCR) after RP, defined as follows:

    • If time to BCR, defined as time to first detectable PSA ( > lower limit of normal for assay used) after RP, is < 12 months, a minimum PSA level of >= 0.2 ng/mL and a confirmatory reading of >= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL are eligible)
    • If time to BCR, defined as time to first detectable PSA (> lower limit of normal for assay used) after RP, is >= 12 months, a minimum absolute PSA of 0.5 ng/mL is required
    • If the patient has a detectable PSA (> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement

  • Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET/CT or PET/MR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT/MRI for soft tissue lesions and/or a bone scan for osseous lesions

    • Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration
  • Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET/CT or PET/MR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration
  • Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET/CT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT.
  • Patient must not be enrolled in another therapeutic clinical trial
  • Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery
  • Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI
  • Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration
  • Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy
  • Hemoglobin (Hgb) >= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)
  • Leukocytes >= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration)
  • Absolute neutrophil count >= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration)
  • Platelets >= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration)
  • Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, must have a direct bilirubin of < 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)
  • Creatine < 1.5 x instituional ULN (or measured creatinine clearance > 30 mL/min)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • 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. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)
  • Patient must not have completed a course of prior pelvic radiation therapy for any reason
  • Patient must agree not to father children while on study

  • Patient must be English or Spanish speaking to be eligible for the QOL component of the study

    • NOTE: Sites cannot translate the associated QOL forms
  • STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA
  • Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration
  • For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)
  • For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields [prostate bed +/- typical whole pelvis]), the number of extra-pelvic lesions must be known (1 - 5 or > 5 extra-pelvic lesions)

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 A (EBRT, short-term androgen deprivation therapy [STAD])

STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.

STEP 1: Patients who are PET negative for extera pelvic metastases undergo SOC EBRT for 6 months. Patients also receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 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: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • EBRT
  • Definitive Radiation Therapy
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
  • Teleradiotherapy
  • Teletherapy
  • Teletherapy Radiation
  • External Beam Radiotherapy (conventional)
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
Drug: Goserelin Acetate
Given SC
Other Names:
  • ZDX
  • Zoladex
Drug: Relugolix
Given PO
Other Names:
  • TAK-385
  • Orgovyx
  • N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea
  • TAK 385
Drug: Leuprolide Acetate
Given IM
Other Names:
  • Enantone
  • LEUP
  • Lupron
  • Lupron Depot
  • Leuprorelin Acetate
  • A-43818
  • Abbott 43818
  • Abbott-43818
  • Carcinil
  • Depo-Eligard
  • Eligard
  • Enanton
  • Enantone-Gyn
  • Ginecrin
  • Leuplin
  • Lucrin
  • Lucrin Depot
  • Lupron Depot-3 Month
  • Lupron Depot-4 Month
  • Lupron Depot-Ped
  • Lutrate
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur
Drug: Degarelix
Given SC
Other Names:
  • Firmagon
  • FE200486
Other: Fluciclovine F18
Given IV
Other Names:
  • (18F)Fluciclovine
  • (18F)GE-148
  • 18F-Fluciclovine
  • [18F]FACBC
  • Anti-(18f)FABC
  • Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
  • Anti-[18F] FACBC
  • Axumin
  • Fluciclovine (18F)
  • FLUCICLOVINE F-18
  • GE-148 (18F)
  • GE-148 F-18
Procedure: Magnetic Resonance Imaging
Undergo PET/MR
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic resonance imaging (procedure)
Procedure: Positron Emission Tomography
Undergo PET/CT or PET/MR
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Drug: Triptorelin
Given IM
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Experimental: Arm B (EBRT, STAD, apalutamide)

STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.

STEP 1: Patients who are PET negative for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD for 6 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: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • EBRT
  • Definitive Radiation Therapy
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
  • Teleradiotherapy
  • Teletherapy
  • Teletherapy Radiation
  • External Beam Radiotherapy (conventional)
Drug: Apalutamide
Given PO
Other Names:
  • ARN-509
  • JNJ-56021927
  • ARN 509
  • ARN509
  • Erleada
  • JNJ 56021927
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
Drug: Goserelin Acetate
Given SC
Other Names:
  • ZDX
  • Zoladex
Drug: Relugolix
Given PO
Other Names:
  • TAK-385
  • Orgovyx
  • N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea
  • TAK 385
Drug: Leuprolide Acetate
Given IM
Other Names:
  • Enantone
  • LEUP
  • Lupron
  • Lupron Depot
  • Leuprorelin Acetate
  • A-43818
  • Abbott 43818
  • Abbott-43818
  • Carcinil
  • Depo-Eligard
  • Eligard
  • Enanton
  • Enantone-Gyn
  • Ginecrin
  • Leuplin
  • Lucrin
  • Lucrin Depot
  • Lupron Depot-3 Month
  • Lupron Depot-4 Month
  • Lupron Depot-Ped
  • Lutrate
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur
Drug: Degarelix
Given SC
Other Names:
  • Firmagon
  • FE200486
Other: Fluciclovine F18
Given IV
Other Names:
  • (18F)Fluciclovine
  • (18F)GE-148
  • 18F-Fluciclovine
  • [18F]FACBC
  • Anti-(18f)FABC
  • Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
  • Anti-[18F] FACBC
  • Axumin
  • Fluciclovine (18F)
  • FLUCICLOVINE F-18
  • GE-148 (18F)
  • GE-148 F-18
Procedure: Magnetic Resonance Imaging
Undergo PET/MR
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic resonance imaging (procedure)
Procedure: Positron Emission Tomography
Undergo PET/CT or PET/MR
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Drug: Triptorelin
Given IM
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Experimental: Arm C (EBRT, STAD, apalutamide)

STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.

STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • EBRT
  • Definitive Radiation Therapy
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
  • Teleradiotherapy
  • Teletherapy
  • Teletherapy Radiation
  • External Beam Radiotherapy (conventional)
Drug: Apalutamide
Given PO
Other Names:
  • ARN-509
  • JNJ-56021927
  • ARN 509
  • ARN509
  • Erleada
  • JNJ 56021927
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
Drug: Goserelin Acetate
Given SC
Other Names:
  • ZDX
  • Zoladex
Drug: Relugolix
Given PO
Other Names:
  • TAK-385
  • Orgovyx
  • N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea
  • TAK 385
Drug: Leuprolide Acetate
Given IM
Other Names:
  • Enantone
  • LEUP
  • Lupron
  • Lupron Depot
  • Leuprorelin Acetate
  • A-43818
  • Abbott 43818
  • Abbott-43818
  • Carcinil
  • Depo-Eligard
  • Eligard
  • Enanton
  • Enantone-Gyn
  • Ginecrin
  • Leuplin
  • Lucrin
  • Lucrin Depot
  • Lupron Depot-3 Month
  • Lupron Depot-4 Month
  • Lupron Depot-Ped
  • Lutrate
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur
Drug: Degarelix
Given SC
Other Names:
  • Firmagon
  • FE200486
Other: Fluciclovine F18
Given IV
Other Names:
  • (18F)Fluciclovine
  • (18F)GE-148
  • 18F-Fluciclovine
  • [18F]FACBC
  • Anti-(18f)FABC
  • Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
  • Anti-[18F] FACBC
  • Axumin
  • Fluciclovine (18F)
  • FLUCICLOVINE F-18
  • GE-148 (18F)
  • GE-148 F-18
Procedure: Magnetic Resonance Imaging
Undergo PET/MR
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic resonance imaging (procedure)
Procedure: Positron Emission Tomography
Undergo PET/CT or PET/MR
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Drug: Triptorelin
Given IM
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Experimental: Arm D (EBRT, STAD, apalutamide, RT)

STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.

STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo SBRT or 3D CRT, IMRT (including VMAT), and IMPT over 3-10 fractions 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: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • EBRT
  • Definitive Radiation Therapy
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
  • Teleradiotherapy
  • Teletherapy
  • Teletherapy Radiation
  • External Beam Radiotherapy (conventional)
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Intensity modulated radiation therapy (procedure)
Drug: Apalutamide
Given PO
Other Names:
  • ARN-509
  • JNJ-56021927
  • ARN 509
  • ARN509
  • Erleada
  • JNJ 56021927
Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SBRT
  • SABR
  • Stereotactic Ablative Body Radiation Therapy
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3D CRT
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
  • 3D Conformal
  • Radiation, 3D Conformal
  • 3D radiotherapy
  • Three dimensional external beam radiation therapy (procedure)
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
Drug: Goserelin Acetate
Given SC
Other Names:
  • ZDX
  • Zoladex
Drug: Relugolix
Given PO
Other Names:
  • TAK-385
  • Orgovyx
  • N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea
  • TAK 385
Procedure: Intensity-Modulated Proton Therapy
Undergo IMPT
Other Names:
  • IMPT
Drug: Leuprolide Acetate
Given IM
Other Names:
  • Enantone
  • LEUP
  • Lupron
  • Lupron Depot
  • Leuprorelin Acetate
  • A-43818
  • Abbott 43818
  • Abbott-43818
  • Carcinil
  • Depo-Eligard
  • Eligard
  • Enanton
  • Enantone-Gyn
  • Ginecrin
  • Leuplin
  • Lucrin
  • Lucrin Depot
  • Lupron Depot-3 Month
  • Lupron Depot-4 Month
  • Lupron Depot-Ped
  • Lutrate
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur
Drug: Degarelix
Given SC
Other Names:
  • Firmagon
  • FE200486
Other: Fluciclovine F18
Given IV
Other Names:
  • (18F)Fluciclovine
  • (18F)GE-148
  • 18F-Fluciclovine
  • [18F]FACBC
  • Anti-(18f)FABC
  • Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
  • Anti-[18F] FACBC
  • Axumin
  • Fluciclovine (18F)
  • FLUCICLOVINE F-18
  • GE-148 (18F)
  • GE-148 F-18
Radiation: Volume Modulated Arc Therapy
Undergo VMAT
Other Names:
  • VMAT
  • Volumetric Modulated Arc Therapy (procedure)
Procedure: Magnetic Resonance Imaging
Undergo PET/MR
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic resonance imaging (procedure)
Procedure: Positron Emission Tomography
Undergo PET/CT or PET/MR
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Drug: Triptorelin
Given IM
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS prolongation in patients with PET-evidence of extrapelvic metastases
Time Frame: Up to 10 years
Will evaluate whether the addition of metastasis-directed radiation therapy to standard of care salvage therapy and enhanced systemic therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel without patients with PET-evidence of extrapelvic metastases.
Up to 10 years
Progression-free survival (PFS)
Time Frame: From randomization to radiographic progression by conventional imaging or positron emission tomography (PET), symptomatic disease or death, whichever occurs first, assessed up to 10 years
The power of the PFS analysis is 85% using one-sided 0.025 level stratified logrank test. The overall type I error will be controlled using an O'Brien-Fleming boundary function
From randomization to radiographic progression by conventional imaging or positron emission tomography (PET), symptomatic disease or death, whichever occurs first, assessed up to 10 years
PFS prolongation in patients without PET-evidence of extrapelvic metastases
Time Frame: Up to 10 years
Will evaluate whether the addition of enhanced systemic therapy to standard of care salvage therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel with patients with PET-evidence of extrapelvic metastases.
Up to 10 years
Quality of life (QOL)
Time Frame: Up to 24 months
Descriptive statistics will be used to characterize QOL over time in each arm.
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From randomization to death or date last known alive, assessed up to 10 years
Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare OS between the two arms in each cohort.
From randomization to death or date last known alive, assessed up to 10 years
Incidence of adverse events
Time Frame: Up to 10 years
Toxicity will be defined using the Common Terminology Criteria for Adverse Events.
Up to 10 years
Event-free survival
Time Frame: From randomization to radiographic progression by conventional imaging or PET, symptomatic disease, or initiation of new treatment for the disease or death, whichever occurs first, assessed up to 10 years
Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare EFS between the two arms in each cohort.
From randomization to radiographic progression by conventional imaging or PET, symptomatic disease, or initiation of new treatment for the disease or death, whichever occurs first, assessed up to 10 years
Time to prostate-specific antigen (PSA) progression
Time Frame: From randomization to documented PSA progression or radiographic progression, whichever occurs first, assessed up to 10 years
Patients without any progression will be censored at the date of last disease assessment that shows free of PSA progression. Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare time to PSA progression between the two arms in each cohort.
From randomization to documented PSA progression or radiographic progression, whichever occurs first, assessed up to 10 years
Detection rate of fluciclovine F18 (18F-fluciclovine) PET
Time Frame: At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
For the detection rate, the proportion of baseline standard of care 18F-fluciclovine PET (PET1) positive results at the patient and regional (prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases) level will be calculated and its 95% confidence interval will be estimated using the Exact method based on the binomial distribution.
At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
Concordance of detection rate with the follow-up conventional imaging modalities (CIM)
Time Frame: At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
Will use Cohen's Kappa coefficient to measure the agreement between dichotomized PET results and the dichotomized CIM results. Baseline CIM comparison will not be performed because as per our study eligibility criteria, baseline CIM will be negative for metastases.
At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
Distribution of 18F-fluciclovine PET-positive lesions among anatomic sites
Time Frame: Baseline
The rate of 18F-fluciclovine PET-positive lesions will be reported for each anatomic site, including prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases. Their confidence intervals will be estimated using the Exact method for the binomial distribution. To evaluate if PSA (level, doubling time, velocity) and other relevant clinical parameters affects the positivity distribution, will use the logistic regression to model with the binary outcome (positive vs. negative from PET) and covariates will include anatomic site, PSA, and other clinical parameters. Will test the interactions between anatomic site and PSA (plus other clinical parameters) to see if the positivity distribution across anatomic site may change according to the levels of the interacted terms. Will use the technique of generalized estimating equation to account for the outcome correlations within subjects.
Baseline
Value of repeat PET to assess response to therapy compared to standard response assessments
Time Frame: At time of second PSA recurrence or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
Analyses will be conducted to evaluate qualitative visual evidence of 18F-fluciclovine PET positive metastatic lesions and quantitative PET standardized-uptake value (SUV) changes on a lesion-to-lesion basis from 18F-fluciclovine PET1 (baseline) to PET2 on visually determined sites of recurrence and metastatic disease. This will be compared to reference standard-of-care conventional imaging (Prostate Cancer Working Group 2 criteria) and PSA response at PET2 time point to determine PET2 response to therapy. PET2 visual and quantitative assessment will also be compared to PFS in the time-to-event analysis using a log-rank test (PET2 visual assessment) and a Cox proportional hazards regression (PET2 quantitative assessment). PET SUV parameters to be obtained at PET1 and PET2 will include SUVmax, SUVpeak. PET SUV change from PET1 to PET2 will include absolute SUVmax and SUVpeak change (PET2-PET1) and percent change of SUVmax and SUVpeak (% change = 100*[(PET2-PET1)/PET1]).)
At time of second PSA recurrence or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
Comparison - Functional Assessment of Cancer Therapy (FACT)- prostate (P)
Time Frame: At baseline and 3, 6, 9, 12 months
For the PET-negative cohort, with 216 analyzable patients in each arm, the study will have about 84% power to detect a 6-point (0.29 standard deviation) difference between the two arms using a two-sample t test with two-sided type I error of 0.05. The power will be greater than 99% if the difference between the two arms is 10 points (0.48 standard deviation). For the PET-positive cohort, with 146 analyzable patients in each arm, the study will have 68% and 98% power to detect a 6-point (0.29 standard deviation) and a 10-point (0.48 standard deviation) differences between the two arms, respectively, using the same test.
At baseline and 3, 6, 9, 12 months
Change in FACT-P and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Time Frame: Baseline up to 6 months
A paired t test will be used to compare FACT-P scores at these two time points in each arm. A two-sample t test will be performed to compare the changes in FACT-P scores from baseline to 6 months between the two arms of each cohort. The FACIT-Fatigue scores at 6 months will be compared between the two arms of each cohort using a two-sample t test.
Baseline up to 6 months
QOL Assessments at Progression
Time Frame: Up to 10 years
A paired t test will be used to compare FACT-P total scores, FACIT-Fatigue scores and pain scores at these two time points in each arm. The changes in these scores from baseline to progression will be evaluated in each arm.
Up to 10 years
FACT- cognitive functioning (Cog)
Time Frame: Up to 12 months
Will be compared between two groups of patients on this study, patients receiving antiandrogen therapy (ADT) + apalutamide (Arms B, C and D) and patients receiving ADT alone (Arm A), at different time points. To ensure similarity of the three arms with systemic treatments (Arms B, C and D), a comparison in FACT-Cog total scores among these three arms will be performed using the Kruskal-Wallis test before combining them together to be compared with Arm A.
Up to 12 months

Collaborators and Investigators

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

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Neha Vapiwala, ECOG-ACRIN Cancer Research Group

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)

October 8, 2020

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Estimated)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA8191 (Other Identifier: CTEP)
  • U10CA180820 (U.S. NIH Grant/Contract)
  • NCI-2020-02686 (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

product manufactured in and exported from the U.S.

Yes

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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