Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

August 11, 2023 updated by: SWOG Cancer Research Network

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone.

SECONDARY OBJECTIVES:

I. To compare overall survival in metastatic prostate cancer patients who received SST plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.

II. To compare the rate of symptomatic local progression between the treatment arms.

III. To compare progression-free survival (PFS) between the two treatment arms. IV. To compare rates of progression-free survival between arms for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites.

QUALITY OF LIFE OBJECTIVES:

I. To compare between arms patient-reported urinary function and urinary bother over time (after initiation of SST at 6 months, 1, 2, and 3 years) using the Expanded Prostate Cancer Index Composite (EPIC) and patient-reported pain and physical functioning using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) between patients receiving standard systemic therapy and those receiving systemic therapy and definitive management of the primary prostate cancer.

OTHER OBJECTIVES:

I. To bank tissue and whole blood specimens for future use.

OUTLINE:

INDUCTION: Participants receive 1 of 6 acceptable forms of SST for 22-28 weeks. I. Participants undergo a bilateral orchiectomy. II. Participants receive goserelin acetate subcutaneously (SC) every 28 days or 12 weeks, histrelin acetate SC every 12 months, leuprolide acetate SC or intramuscularly (IM) every 1, 3, 4, or 6 months, and triptorelin every 1, 3, or 6 months.

III. Participants receive goserelin acetate SC every 28 days or 12 weeks, histrelin acetate SC every 12 months, leuprolide acetate SC or IM every 1, 3, 4, or 6 months, and triptorelin every 1, 3, or 6 months. Participants also receive nilutamide orally (PO) daily, flutamide PO every 8 hours, and bicalutamide PO daily.

IV. Participants receive degarelix via injection for 2 doses and then every 28 days.

V. Participants receive nilutamide PO daily, flutamide PO every 8 hours, and bicalutamide PO daily. Participants also receive docetaxel over 1 hour every 3 weeks with or without prednisone PO every 12 hours.

VI. Participants receive nilutamide PO daily, flutamide PO every 8 hours, and bicalutamide PO daily. Participants also receive abiraterone PO daily or prednisone PO every 12 hours.

After completion of 22-28 weeks of SST, participants are then randomized to 1 of 2 arms.

ARM I: Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.

ARM II: Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization.

After completion of study treatment, participants are followed up for 8 years.

Study Type

Interventional

Enrollment (Estimated)

1273

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 Contact

Study Locations

  • Chile
      • Independence, Chile, 8380455
        • Recruiting
        • Instituto Nacional del Cancer
        • Contact:
        • Principal Investigator:
          • Annerleim Walton-diaz
  • Colombia
      • Bogota, Colombia, 99999
        • Recruiting
        • Instituto Nacional de Cancerología
        • Contact:
          • Site Public Contact
          • Phone Number: 57 1 3341111
        • Principal Investigator:
          • Marino Cabrera
  • Mexico
    • Tlalpan
      • Mexico City, Tlalpan, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cancerología de México
        • Contact:
          • Site Public Contact
          • Phone Number: (52) 5628-0400
        • Principal Investigator:
          • Miguel A. Jimenez-Rios
  • Switzerland
      • Aarau, Switzerland, 5001
        • Recruiting
        • Kantonsspital Aarau
        • Contact:
          • Site Public Contact
          • Phone Number: 41 62 838 60 50
        • Principal Investigator:
          • Oliver Riesterer
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
        • Principal Investigator:
          • Chinedu Mmeje
        • Contact:
          • Site Public Contact
          • Phone Number: 602-747-9738
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • Cancer Center at Saint Joseph's
        • Contact:
        • Principal Investigator:
          • Shahzad Siddique
      • Phoenix, Arizona, United States, 85054
        • Suspended
        • Mayo Clinic Hospital in Arizona
      • Scottsdale, Arizona, United States, 85259
        • Suspended
        • Mayo Clinic in Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-North Campus
        • Principal Investigator:
          • Juan Chipollini
        • Contact:
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • University of Arizona Cancer Center-Orange Grove Campus
        • Principal Investigator:
          • Juan Chipollini
        • Contact:
          • Site Public Contact
          • Phone Number: 520-694-8900
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Principal Investigator:
          • Shi-Ming Tu
        • Contact:
          • Site Public Contact
          • Phone Number: 501-686-8274
    • California
      • Antioch, California, United States, 94531
        • Recruiting
        • Kaiser Permanente-Deer Valley Medical Center
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Clovis, California, United States, 93611
        • Recruiting
        • Community Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 559-387-1827
        • Principal Investigator:
          • Uzair B. Chaudhary
      • Clovis, California, United States, 93611
        • Suspended
        • University Oncology Associates
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Tanya B. Dorff
      • Dublin, California, United States, 94568
        • Recruiting
        • Kaiser Permanente Dublin
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
      • Fremont, California, United States, 94538
        • Recruiting
        • Kaiser Permanente-Fremont
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Fresno, California, United States, 93720
        • Recruiting
        • Kaiser Permanente-Fresno
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Fresno, California, United States, 93720
        • Recruiting
        • Fresno Cancer Center
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Aditya Bagrodia
        • Contact:
      • Long Beach, California, United States, 90822
        • Recruiting
        • Tibor Rubin VA Medical Center
        • Principal Investigator:
          • Greg Gin
        • Contact:
          • Site Public Contact
          • Phone Number: 562-826-8000
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Principal Investigator:
          • Siamak Daneshmand
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles County-USC Medical Center
        • Principal Investigator:
          • Siamak Daneshmand
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
      • Marysville, California, United States, 95901
        • Recruiting
        • Fremont - Rideout Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 530-749-4400
        • Principal Investigator:
          • Richard K. Valicenti
      • Modesto, California, United States, 95356
        • Recruiting
        • Kaiser Permanente-Modesto
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente-Oakland
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente Oakland-Broadway
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Palm Springs, California, United States, 92262
        • Recruiting
        • Desert Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 760-416-4730
        • Principal Investigator:
          • Amir Lavaf
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute Palo Alto
        • Principal Investigator:
          • Geoffrey A. Sonn
        • Contact:
      • Rancho Cordova, California, United States, 95670
        • Recruiting
        • Kaiser Permanente-Rancho Cordova Cancer Center
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Redwood City, California, United States, 94063
        • Recruiting
        • Kaiser Permanente-Redwood City
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Richmond, California, United States, 94801
        • Recruiting
        • Kaiser Permanente-Richmond
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Rohnert Park, California, United States, 94928
        • Recruiting
        • Rohnert Park Cancer Center
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Roseville, California, United States, 95661
        • Recruiting
        • Kaiser Permanente-Roseville
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Roseville, California, United States, 95678
        • Recruiting
        • The Permanente Medical Group-Roseville Radiation Oncology
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Richard K. Valicenti
      • Sacramento, California, United States, 95814
        • Recruiting
        • Kaiser Permanente Downtown Commons
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Sacramento, California, United States, 95823
        • Recruiting
        • Kaiser Permanente-South Sacramento
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Sacramento, California, United States, 95816
        • Recruiting
        • Mercy Cancer Center - Sacramento
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Sacramento, California, United States, 95823
        • Recruiting
        • South Sacramento Cancer Center
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente-San Francisco
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • San Jose, California, United States, 95119
        • Recruiting
        • Kaiser Permanente-Santa Teresa-San Jose
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • San Leandro, California, United States, 94577
        • Recruiting
        • Kaiser Permanente San Leandro
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • San Luis Obispo, California, United States, 93401
      • San Rafael, California, United States, 94903
        • Recruiting
        • Kaiser San Rafael-Gallinas
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente Medical Center - Santa Clara
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Kaiser Permanente-Santa Rosa
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • South San Francisco, California, United States, 94080
        • Recruiting
        • Kaiser Permanente-South San Francisco
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • South San Francisco, California, United States, 94080
        • Recruiting
        • Kaiser Permanente Cancer Treatment Center
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Stockton, California, United States, 95210
        • Recruiting
        • Kaiser Permanente-Stockton
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Truckee, California, United States, 96161
        • Recruiting
        • Gene Upshaw Memorial Tahoe Forest Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 530-582-6450
        • Principal Investigator:
          • Richard K. Valicenti
      • Vacaville, California, United States, 95688
        • Recruiting
        • Kaiser Permanente Medical Center-Vacaville
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente-Vallejo
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Kaiser Permanente-Walnut Creek
        • Principal Investigator:
          • Andrea L. Harzstark
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital
        • Principal Investigator:
          • Paul D. Maroni
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
      • Boulder, Colorado, United States, 80304
        • Recruiting
        • Rocky Mountain Cancer Centers-Boulder
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • UCHealth Memorial Hospital Central
        • Principal Investigator:
          • Paul D. Maroni
        • Contact:
          • Site Public Contact
          • Phone Number: 719-365-2406
      • Colorado Springs, Colorado, United States, 80920
        • Recruiting
        • Memorial Hospital North
        • Principal Investigator:
          • Paul D. Maroni
        • Contact:
          • Site Public Contact
          • Phone Number: 719-364-6700
      • Denver, Colorado, United States, 80210
        • Recruiting
        • Porter Adventist Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Edwards, Colorado, United States, 81632
        • Recruiting
        • Shaw Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 970-569-7429
        • Principal Investigator:
          • Patricia H. Hardenbergh
      • Fort Collins, Colorado, United States, 80524
        • Recruiting
        • Poudre Valley Hospital
        • Principal Investigator:
          • Paul D. Maroni
        • Contact:
          • Site Public Contact
          • Phone Number: 970-297-6150
      • Greeley, Colorado, United States, 80631
      • Littleton, Colorado, United States, 80122
        • Recruiting
        • Littleton Adventist Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Loveland, Colorado, United States, 80539
      • Parker, Colorado, United States, 80138
        • Recruiting
        • Parker Adventist Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
    • Connecticut
      • Guilford, Connecticut, United States, 06437
        • Recruiting
        • Smilow Cancer Hospital Care Center - Guilford
        • Principal Investigator:
          • Preston C. Sprenkle
        • Contact:
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Preston C. Sprenkle
        • Contact:
      • Stamford, Connecticut, United States, 06904
        • Recruiting
        • Stamford Hospital/Bennett Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 203-323-8944
        • Principal Investigator:
          • Anthony P. Gulati
      • Trumbull, Connecticut, United States, 06611
        • Recruiting
        • Smilow Cancer Hospital Care Center-Trumbull
        • Principal Investigator:
          • Preston C. Sprenkle
        • Contact:
      • Waterford, Connecticut, United States, 06385
        • Recruiting
        • Smilow Cancer Hospital Care Center - Waterford
        • Principal Investigator:
          • Preston C. Sprenkle
        • Contact:
      • West Haven, Connecticut, United States, 06516
        • Recruiting
        • Veterans Affairs Connecticut Healthcare System-West Haven Campus
        • Principal Investigator:
          • Preston C. Sprenkle
        • Contact:
          • Site Public Contact
          • Phone Number: 2832 203-937-3421
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Health System-Christiana Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Active, not recruiting
        • MedStar Georgetown University Hospital
      • Washington, District of Columbia, United States, 20037
        • Recruiting
        • George Washington University Medical Center
        • Principal Investigator:
          • Michael J. Whalen
        • Contact:
          • Site Public Contact
          • Phone Number: 202-741-2981
      • Washington, District of Columbia, United States, 20010
        • Active, not recruiting
        • MedStar Washington Hospital Center
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center at Aventura
        • Contact:
        • Principal Investigator:
          • Michael A. Schwartz
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Principal Investigator:
          • Chad R. Ritch
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Principal Investigator:
          • Chad R. Ritch
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Principal Investigator:
          • Jonathan J. Melquist
        • Contact:
          • Site Public Contact
          • Phone Number: 904-202-7468
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Principal Investigator:
          • Chad R. Ritch
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Miami, Florida, United States, 33176
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Principal Investigator:
          • Chad R. Ritch
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Michael A. Schwartz
      • Orlando, Florida, United States, 32806
        • Active, not recruiting
        • Orlando Health Cancer Institute
      • Plantation, Florida, United States, 33324
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Principal Investigator:
          • Chad R. Ritch
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Principal Investigator:
          • Shreyas Joshi
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Principal Investigator:
          • Shreyas Joshi
        • Contact:
          • Site Public Contact
          • Phone Number: 404-489-9164
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Principal Investigator:
          • Shreyas Joshi
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Principal Investigator:
          • Shreyas Joshi
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Medical Center
        • Principal Investigator:
          • Sharad A. Ghamande
        • Contact:
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Atlanta VA Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 7632 404-321-6111
        • Principal Investigator:
          • Wayne B. Harris
    • Idaho
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • 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:
    • 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
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Srinivas Vourganti
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Principal Investigator:
          • Daniel Moreira
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States, 60611
        • Active, not recruiting
        • Northwestern University
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • 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
      • 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
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
        • Principal Investigator:
          • Ami Badami
      • 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
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Swansea, Illinois, United States, 62226
        • Suspended
        • Southwest Illinois Health Services LLP
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Active, not recruiting
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Richmond, Indiana, United States, 47374
        • Recruiting
        • Reid Health
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
        • Principal Investigator:
          • Yousef Zakharia
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • William Parker
      • Olathe, Kansas, United States, 66061
        • Recruiting
        • Olathe Health Cancer Center
        • Contact:
        • Principal Investigator:
          • William Parker
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • University of Kansas Cancer Center-Overland Park
        • Contact:
        • Principal Investigator:
          • William Parker
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Contact:
        • Principal Investigator:
          • William Parker
    • Kentucky
      • Lexington, Kentucky, United States, 40509
      • Lexington, Kentucky, United States, 40504
      • Lexington, Kentucky, United States, 40536
        • Not yet recruiting
        • University of Kentucky/Markey Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
        • Principal Investigator:
          • Patrick J. Hensley
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The James Graham Brown Cancer Center at University of Louisville
        • Principal Investigator:
          • Scott R. Silva
        • Contact:
          • Site Public Contact
          • Phone Number: 502-562-3429
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • East Jefferson General Hospital
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
        • Contact:
        • Principal Investigator:
          • Scott E. Delacroix
    • Maine
      • Bath, Maine, United States, 04530
        • Recruiting
        • MaineHealth Coastal Cancer Treatment Center
        • Principal Investigator:
          • Matthew H. Hayn
        • Contact:
      • Brewer, Maine, United States, 04412
        • Recruiting
        • Lafayette Family Cancer Center-EMMC
        • Principal Investigator:
          • Sarah J. Sinclair
        • Contact:
          • Site Public Contact
          • Phone Number: 800-987-3005
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Medical Center-Bramhall Campus
        • Principal Investigator:
          • Matthew H. Hayn
        • Contact:
          • Site Public Contact
          • Phone Number: 207-885-7565
      • Sanford, Maine, United States, 04073
        • Recruiting
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
        • Principal Investigator:
          • Matthew H. Hayn
        • Contact:
      • Sanford, Maine, United States, 04073
        • Recruiting
        • MaineHealth Cancer Care Center of York County
        • Principal Investigator:
          • Matthew H. Hayn
        • Contact:
          • Site Public Contact
          • Phone Number: 207-459-1600
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Maine Medical Center- Scarborough Campus
        • Principal Investigator:
          • Matthew H. Hayn
        • Contact:
          • Site Public Contact
          • Phone Number: 207-396-8090
          • Email: wrighd@mmc.org
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Active, not recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Active, not recruiting
        • Lahey Hospital and Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
        • Principal Investigator:
          • Samuel D. Kaffenberger
      • Brighton, Michigan, United States, 48114
      • Brownstown, Michigan, United States, 48183
        • Recruiting
        • Henry Ford Cancer Institute-Downriver
        • Contact:
        • Principal Investigator:
          • Haythem Y. Ali
      • Canton, Michigan, United States, 48188
      • Chelsea, Michigan, United States, 48118
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • GenesisCare USA - Clarkston
        • Contact:
        • Principal Investigator:
          • Frank A. Vicini
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Henry Ford Macomb Hospital-Clinton Township
        • Contact:
        • Principal Investigator:
          • Haythem Y. Ali
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University/Karmanos Cancer Institute
        • Principal Investigator:
          • Elisabeth I. Heath
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Haythem Y. Ali
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • GenesisCare USA - Farmington Hills
        • Contact:
        • Principal Investigator:
          • Frank A. Vicini
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Sparrow Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
          • Site Public Contact
          • Phone Number: 517-364-9400
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • GenesisCare USA - Macomb
        • Contact:
        • Principal Investigator:
          • Frank A. Vicini
      • Madison Heights, Michigan, United States, 48071
        • Recruiting
        • GenesisCare USA - Madison Heights
        • Contact:
        • Principal Investigator:
          • Frank A. Vicini
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • 21st Century Oncology-Pontiac
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Saginaw, Michigan, United States, 48601
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Troy, Michigan, United States, 48098
        • Recruiting
        • GenesisCare USA - Troy
        • Contact:
        • Principal Investigator:
          • Frank A. Vicini
      • West Bloomfield, Michigan, United States, 48322
        • Recruiting
        • Henry Ford West Bloomfield Hospital
        • Contact:
        • Principal Investigator:
          • Haythem Y. Ali
    • Minnesota
      • 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
        • Recruiting
        • Unity 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
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Rochester, Minnesota, United States, 55905
        • Suspended
        • Mayo Clinic in Rochester
      • 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
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Suspended
        • University of Mississippi Medical Center
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Southeast Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-651-5550
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri - Ellis Fischel
        • Contact:
          • Site Public Contact
          • Phone Number: 573-882-7440
        • Principal Investigator:
          • Kushal Naha
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Jeff M. Michalski
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • University of Kansas Cancer Center - North
        • Contact:
        • Principal Investigator:
          • William Parker
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Delbert Day Cancer Institute at PCRMC
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Jeff M. Michalski
      • Saint Louis, Missouri, United States, 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 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
    • 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:
      • Butte, Montana, United States, 59701
        • Recruiting
        • Saint James Community Hospital and Cancer Treatment Center
        • Contact:
          • Site Public Contact
          • Phone Number: 406-723-2621
        • Principal Investigator:
          • Troy A. Fiddler
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Kalispell Regional Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Nebraska Medicine-Bellevue
        • Contact:
        • Principal Investigator:
          • Benjamin A. Teply
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University Of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Benjamin A. Teply
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 402-354-5144
        • Principal Investigator:
          • Ralph J. Hauke
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Medicine-Village Pointe
        • Contact:
          • Site Public Contact
          • Phone Number: 402-559-5600
        • Principal Investigator:
          • Benjamin A. Teply
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Radiation Oncology Centers of Nevada Central
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Northwest
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Summerlin
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Central Valley
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • Recruiting
        • New Hampshire Oncology Hematology PA-Concord
        • Contact:
          • Site Public Contact
          • Phone Number: 603-224-2556
        • Principal Investigator:
          • Douglas J. Weckstein
      • Dover, New Hampshire, United States, 03820
        • Active, not recruiting
        • Wentworth-Douglass Hospital
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Rodwell Mabaera
      • Manchester, New Hampshire, United States, 03103
        • Recruiting
        • Solinsky Center for Cancer Care
        • Principal Investigator:
          • Douglas J. Weckstein
        • Contact:
          • Site Public Contact
          • Phone Number: 800-339-6484
      • Manchester, New Hampshire, United States, 03103
        • Active, not recruiting
        • Elliot Hospital
    • New Jersey
      • 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
      • Teaneck, New Jersey, United States, 07666
        • Active, not recruiting
        • Holy Name Hospital
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Principal Investigator:
          • Badar M. Mian
        • Contact:
          • Site Public Contact
          • Phone Number: 518-262-5513
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Einstein Campus
        • Principal Investigator:
          • Ahmed A. Aboumohamed
        • Contact:
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Principal Investigator:
          • Ahmed A. Aboumohamed
        • Contact:
      • Bronx, New York, United States, 10468
        • Active, not recruiting
        • James J Peters VA Medical Center
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Gurkamal S. Chatta
      • Dansville, New York, United States, 14437
      • Glens Falls, New York, United States, 12801
        • Recruiting
        • Glens Falls Hospital
        • Principal Investigator:
          • Nataniel H. Lester-Coll
        • Contact:
          • Site Public Contact
          • Phone Number: 518-926-6700
      • Lake Success, New York, United States, 11042
        • Active, not recruiting
        • Northwell Health/Center for Advanced Medicine
      • New York, New York, United States, 10065
        • Recruiting
        • NYP/Weill Cornell Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-746-1848
        • Principal Investigator:
          • Douglas Scherr
      • Oneida, New York, United States, 13421
        • Recruiting
        • Upstate Cancer Center Radiation Oncology at Oneida
        • Principal Investigator:
          • Gennady Bratslavsky
        • Contact:
      • Oswego, New York, United States, 13126
        • Recruiting
        • Upstate Cancer Center Radiation Oncology at Oswego
        • Principal Investigator:
          • Gennady Bratslavsky
        • Contact:
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Paul M. Barr
      • Rochester, New York, United States, 14620
        • Recruiting
        • Highland Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 585-341-8113
        • Principal Investigator:
          • Paul M. Barr
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Principal Investigator:
          • Massimiliano Spaliviero
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Principal Investigator:
          • Gennady Bratslavsky
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
    • North Carolina
      • Albemarle, North Carolina, United States, 28002
        • Recruiting
        • Atrium Health Stanly/LCI-Albemarle
        • Principal Investigator:
          • Earle F. Burgess
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Asheville, North Carolina, United States, 28801
        • Active, not recruiting
        • Mission Hospital
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Principal Investigator:
          • Earle F. Burgess
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • Atrium Health Pineville/LCI-Pineville
        • Principal Investigator:
          • Earle F. Burgess
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
      • Charlotte, North Carolina, United States, 28262
        • Recruiting
        • Atrium Health University City/LCI-University
        • Principal Investigator:
          • Earle F. Burgess
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Levine Cancer Institute-Ballantyne
        • Principal Investigator:
          • Earle F. Burgess
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Concord, North Carolina, United States, 28025
        • Recruiting
        • Atrium Health Cabarrus/LCI-Concord
        • Principal Investigator:
          • Earle F. Burgess
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Levine Cancer Institute-Gaston
        • Principal Investigator:
          • Earle F. Burgess
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Hendersonville, North Carolina, United States, 28791
        • Recruiting
        • Margaret R Pardee Memorial Hospital
        • Principal Investigator:
          • Praveen Vashist
        • Contact:
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Atrium Health Union/LCI-Union
        • Principal Investigator:
          • Earle F. Burgess
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
      • New Bern, North Carolina, United States, 28561
        • Recruiting
        • CarolinaEast Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah B. Carroll
    • Ohio
      • Canton, Ohio, United States, 44708
        • Recruiting
        • Cleveland Clinic Mercy Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 888-293-4673
        • Principal Investigator:
          • Mitchell Haut
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Contact:
        • Principal Investigator:
          • Abhinav Sidana
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth Medical Center
        • Contact:
        • Principal Investigator:
          • William Tse
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Steven K. Clinton
        • Contact:
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Kettering, Ohio, United States, 45409
        • Recruiting
        • Greater Dayton Cancer Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Medical Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Sylvania, Ohio, United States, 43560
        • Recruiting
        • ProMedica Flower Hospital
        • Principal Investigator:
          • Jeffrey A. Forquer
        • Contact:
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
        • Principal Investigator:
          • Jeffrey A. Forquer
        • Contact:
      • Toledo, Ohio, United States, 43614
        • Suspended
        • University of Toledo
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Contact:
        • Principal Investigator:
          • Abhinav Sidana
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Kelly L. Stratton
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Active, not recruiting
        • Legacy Mount Hood Medical Center
      • Portland, Oregon, United States, 97210
        • Active, not recruiting
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, United States, 97239
        • Active, not recruiting
        • Oregon Health and Science University
    • Pennsylvania
      • Chambersburg, Pennsylvania, United States, 17201
        • Recruiting
        • Chambersburg Hospital
        • Contact:
        • Principal Investigator:
          • Sherif F. Yacoub
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Ahmad Hanif
      • Ephrata, Pennsylvania, United States, 17522
        • Recruiting
        • Ephrata Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 717-721-4840
        • Principal Investigator:
          • Sherif F. Yacoub
      • Gettysburg, Pennsylvania, United States, 17325
        • Recruiting
        • Adams Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
        • Principal Investigator:
          • Sherif F. Yacoub
      • Lebanon, Pennsylvania, United States, 17042
        • Recruiting
        • Sechler Family Cancer Center
        • Contact:
        • Principal Investigator:
          • Sherif F. Yacoub
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Ahmad Hanif
      • Philadelphia, Pennsylvania, United States, 19140
        • Withdrawn
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
        • Principal Investigator:
          • Benjamin J. Davies
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC-Shadyside Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-621-2334
        • Principal Investigator:
          • Benjamin J. Davies
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Ahmad Hanif
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health-York Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
        • Principal Investigator:
          • Sherif F. Yacoub
    • South Carolina
      • Boiling Springs, South Carolina, United States, 29316
        • Recruiting
        • Prisma Health Cancer Institute - Spartanburg
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • David T. Marshall
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Faris
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Saint Francis Cancer Center
        • Contact:
        • Principal Investigator:
          • Jennifer Vogel
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute - Eastside
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Greer, South Carolina, United States, 29650
        • Recruiting
        • Prisma Health Cancer Institute - Greer
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Myrtle Beach, South Carolina, United States, 29577
        • Recruiting
        • Carolina Regional Cancer Center
        • Principal Investigator:
          • Frank A. Vicini
        • Contact:
          • Site Public Contact
          • Phone Number: 877-460-2657
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Levine Cancer Institute-Rock Hill
        • Principal Investigator:
          • Earle F. Burgess
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Rock Hill, South Carolina, United States, 29730
        • Recruiting
        • Rock Hill Radiation Therapy Center
        • Principal Investigator:
          • Earle F. Burgess
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Seneca, South Carolina, United States, 29672
        • Recruiting
        • Prisma Health Cancer Institute - Seneca
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Principal Investigator:
          • Kerry R. Schaffer
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
    • Texas
      • Conroe, Texas, United States, 77384
        • Recruiting
        • MD Anderson in The Woodlands
        • Principal Investigator:
          • Brian F. Chapin
        • Contact:
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Suzanne M. Cole
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Parkland Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Suzanne M. Cole
      • Dallas, Texas, United States, 75237
        • Recruiting
        • UT Southwestern Simmons Cancer Center - RedBird
        • Contact:
        • Principal Investigator:
          • Suzanne M. Cole
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Contact:
        • Principal Investigator:
          • Suzanne M. Cole
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Brian F. Chapin
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Principal Investigator:
          • Martha P. Mims
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
      • Houston, Texas, United States, 77030
        • Recruiting
        • Ben Taub General Hospital
        • Principal Investigator:
          • Martha P. Mims
        • Contact:
          • Site Public Contact
          • Phone Number: 713-873-2000
      • Houston, Texas, United States, 77079
        • Recruiting
        • MD Anderson West Houston
        • Principal Investigator:
          • Brian F. Chapin
        • Contact:
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77026-1967
        • Recruiting
        • Lyndon Baines Johnson General Hospital
        • Principal Investigator:
          • Brian F. Chapin
        • Contact:
          • Site Public Contact
          • Phone Number: 713-566-5000
      • Houston, Texas, United States, 77030
        • Recruiting
        • Michael E DeBakey VA Medical Center
        • Principal Investigator:
          • Aihua E. Yen
        • Contact:
          • Site Public Contact
          • Phone Number: 800-553-2278
      • League City, Texas, United States, 77573
        • Recruiting
        • MD Anderson League City
        • Principal Investigator:
          • Brian F. Chapin
        • Contact:
      • Richardson, Texas, United States, 75080
        • Recruiting
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contact:
        • Principal Investigator:
          • Suzanne M. Cole
      • 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
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • MD Anderson in Sugar Land
        • Principal Investigator:
          • Brian F. Chapin
        • Contact:
      • Temple, Texas, United States, 76508
        • Active, not recruiting
        • Scott and White Memorial Hospital
    • Utah
      • American Fork, Utah, United States, 84003
        • Suspended
        • American Fork Hospital / Huntsman Intermountain Cancer Center
      • Cedar City, Utah, United States, 84720
        • Suspended
        • Sandra L Maxwell Cancer Center
      • Logan, Utah, United States, 84321
        • Suspended
        • Logan Regional Hospital
      • Murray, Utah, United States, 84107
        • Suspended
        • Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • Suspended
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Suspended
        • Utah Valley Regional Medical Center
      • Riverton, Utah, United States, 84065
        • Suspended
        • Riverton Hospital
      • Saint George, Utah, United States, 84770
        • Suspended
        • Saint George Regional Medical Center
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • University of Utah Sugarhouse Health Center
        • Principal Investigator:
          • Alejandro Sanchez
        • Contact:
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Principal Investigator:
          • Alejandro Sanchez
        • Contact:
      • Salt Lake City, Utah, United States, 84106
        • Suspended
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, United States, 84143
        • Suspended
        • LDS Hospital
      • Salt Lake City, Utah, United States, 84148
        • Recruiting
        • George E Wahlen Department of Veterans Affairs Medical Center
        • Principal Investigator:
          • Sumati V. Gupta
        • Contact:
          • Site Public Contact
          • Phone Number: 801-582-1565
    • Vermont
      • Berlin, Vermont, United States, 05602
        • Recruiting
        • Central Vermont Medical Center/National Life Cancer Treatment
        • Principal Investigator:
          • Nataniel H. Lester-Coll
        • Contact:
          • Site Public Contact
          • Phone Number: 802-225-5400
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Principal Investigator:
          • Nataniel H. Lester-Coll
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-4101
          • Email: rpo@uvm.edu
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • William J. Irvin
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Contact:
        • Principal Investigator:
          • Asit K. Paul
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Principal Investigator:
          • Asit K. Paul
      • Richmond, Virginia, United States, 23230
        • Recruiting
        • Bon Secours Cancer Institute at Reynolds Crossing
        • Contact:
        • Principal Investigator:
          • William J. Irvin
      • South Hill, Virginia, United States, 23970
        • Recruiting
        • VCU Community Memorial Health Center
        • Contact:
        • Principal Investigator:
          • Asit K. Paul
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • FHCC Overlake
        • Contact:
          • Site Public Contact
          • Phone Number: 425-454-2148
        • Principal Investigator:
          • Jason Comer
      • Kirkland, Washington, United States, 98034
        • Recruiting
        • Seattle Cancer Care Alliance at EvergreenHealth
        • Contact:
          • Site Public Contact
          • Phone Number: 425-899-6000
        • Principal Investigator:
          • Eric W. Dean
      • Seattle, Washington, United States, 98109
        • Recruiting
        • FHCC South Lake Union
        • Principal Investigator:
          • Daniel W. Lin
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center - Montlake
        • Principal Investigator:
          • Daniel W. Lin
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
      • Seattle, Washington, United States, 98133
        • Recruiting
        • FHCC at Northwest Hospital
        • Principal Investigator:
          • Nikhil V. Kamat
        • Contact:
          • Site Public Contact
          • Phone Number: 206-606-5800
      • Vancouver, Washington, United States, 98686
        • Active, not recruiting
        • Legacy Salmon Creek Hospital
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Principal Investigator:
          • Danh C. Pham
        • Contact:
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Langlade Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Christopher S. Platta
      • Eau Claire, Wisconsin, United States, 54701
      • La Crosse, Wisconsin, United States, 54601
        • Active, not recruiting
        • Mayo Clinic Health System-Franciscan Healthcare
      • Marshfield, Wisconsin, United States, 54449
      • Menomonee Falls, Wisconsin, United States, 53051
        • Recruiting
        • Froedtert Menomonee Falls Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 262-257-5100
        • Principal Investigator:
          • Scott Johnson
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • Scott Johnson
      • Milwaukee, Wisconsin, United States, 53295
        • Recruiting
        • Zablocki Veterans Administration Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-469-6614
        • Principal Investigator:
          • Elizabeth M. Gore
      • Minocqua, Wisconsin, United States, 54548
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • David M. King
      • Oak Creek, Wisconsin, United States, 53154
        • Recruiting
        • Drexel Town Square Health Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Scott Johnson
      • Rice Lake, Wisconsin, United States, 54868
      • Stevens Point, Wisconsin, United States, 54482
      • Stevens Point, Wisconsin, United States, 54481
        • Recruiting
        • Ascension Saint Michael's Hospital
        • Contact:
        • Principal Investigator:
          • Christopher S. Platta
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
        • Principal Investigator:
          • Christopher S. Platta
      • West Bend, Wisconsin, United States, 53095
        • Recruiting
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Scott Johnson
      • Weston, Wisconsin, United States, 54476
      • Weston, Wisconsin, United States, 54476
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Recruiting
        • Aspirus Cancer Care - Wisconsin Rapids
        • Contact:
          • Site Public Contact
          • Phone Number: 715-422-7718
        • Principal Investigator:
          • Christopher S. Platta

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 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).
  • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound [HIFU], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).
  • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride [NaF], prostate-specific membrane antigen [PSMA], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid [FACBC], carbon [C]11) but not conventional imaging (technetium [Tc]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.
  • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease.
  • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received no more than 28 weeks of standard systemic therapy (SST). SST is defined as current National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate cancer.
  • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have progressed while on SST.
  • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a complete physical examination and medical history within 28 days prior to registration.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA documented prior to initiation of SST and within 28 days prior to registration. Any additional PSAs measured while receiving SST should be recorded.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone lab documented within 28 days prior to randomization. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
  • STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies.
  • STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.
  • STEP 1 REGISTRATION: REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
  • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of disease progression during the 28 weeks of SST by PSA measure, bone scan and CT or MRI or symptomatic deterioration (as defined by physician discretion) within 28 days prior to randomization.
  • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received between 22 and 28 weeks of SST as measured from the date of first hormonal therapy or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not be planning to receive docetaxel after randomization.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Any toxicities from SST must have resolved to =< grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) prior to randomization.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients may have received elective metastasis directed therapy to oligometastatic sites (=< 4 sites). All treatment must be completed prior to randomization.
  • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA performed within 28 days prior to randomization.
  • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone < 50 ng/dL within 28 days prior to randomization.
  • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a Zubrod performance status of 0 ? 1 within 28 days prior to randomization.

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (SST)
Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Drug: Bicalutamide
Given PO
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334
Drug: Degarelix
Given via injection
Other Names:
  • Firmagon
  • FE200486
Drug: Flutamide
Given PO
Other Names:
  • Apimid
  • Cebatrol
  • Chimax
  • Cytomid
  • Drogenil
  • Euflex
  • Eulexine
  • Flucinom
  • Flucinome
  • Flugerel
  • Fluken
  • Flulem
  • FLUT
  • Fluta-Gry
  • Flutabene
  • Flutacan
  • Flutamex
  • Flutamin
  • Flutan
  • Flutaplex
  • Fugerel
  • Grisetin
  • Niftolide
  • Oncosal
  • Profamid
  • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
  • Prostacur
  • Prostadirex
  • Prostica
  • Prostogenat
  • Tafenil
  • Tecnoflut
  • Testotard
  • 4'-Nitro-3'-trifluoromethylisobutyranilide
  • SCH 13521
Drug: Nilutamide
Given PO
Other Names:
  • Anandron
  • Nilandron
  • RU-23908
Drug: Goserelin Acetate
Given SC
Other Names:
  • ZDX
  • Zoladex
Drug: Abiraterone
Given PO
Other Names:
  • CB 7598
Drug: Histrelin Acetate
Receive SC
Other Names:
  • Vantas
  • Supprelin
Drug: Leuprolide Acetate
Receive SC or 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
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur
Procedure: Orchiectomy
Undergo bilateral orchiectomy
Other Names:
  • Castration
  • Male Castration
  • Male Gonadectomy
  • orchidectomy
Drug: Triptorelin
injection
Other Names:
  • Decapeptyl
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Experimental: Arm II (SST, prostatectomy or radiation therapy)
Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Drug: Bicalutamide
Given PO
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334
Drug: Degarelix
Given via injection
Other Names:
  • Firmagon
  • FE200486
Drug: Flutamide
Given PO
Other Names:
  • Apimid
  • Cebatrol
  • Chimax
  • Cytomid
  • Drogenil
  • Euflex
  • Eulexine
  • Flucinom
  • Flucinome
  • Flugerel
  • Fluken
  • Flulem
  • FLUT
  • Fluta-Gry
  • Flutabene
  • Flutacan
  • Flutamex
  • Flutamin
  • Flutan
  • Flutaplex
  • Fugerel
  • Grisetin
  • Niftolide
  • Oncosal
  • Profamid
  • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
  • Prostacur
  • Prostadirex
  • Prostica
  • Prostogenat
  • Tafenil
  • Tecnoflut
  • Testotard
  • 4'-Nitro-3'-trifluoromethylisobutyranilide
  • SCH 13521
Drug: Nilutamide
Given PO
Other Names:
  • Anandron
  • Nilandron
  • RU-23908
Drug: Goserelin Acetate
Given SC
Other Names:
  • ZDX
  • Zoladex
Drug: Abiraterone
Given PO
Other Names:
  • CB 7598
Drug: Histrelin Acetate
Receive SC
Other Names:
  • Vantas
  • Supprelin
Drug: Leuprolide Acetate
Receive SC or 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
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur
Procedure: Orchiectomy
Undergo bilateral orchiectomy
Other Names:
  • Castration
  • Male Castration
  • Male Gonadectomy
  • orchidectomy
Drug: Triptorelin
injection
Other Names:
  • Decapeptyl
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Radiation: Radiation Therapy
Standard radiation
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Radiation
  • Radiotherapeutics
  • RT
  • Therapy, Radiation
  • irradiation
  • RADIOTHERAPY
Procedure: Radical Prostatectomy
Standard surgery
Other Names:
  • Prostatovesiculectomy
Active Comparator: Step 1 (pre-randomization)
Standard treatment data collection prior to randomization
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Drug: Prednisone
Given PO
Other Names:
  • Deltasone
  • Orasone
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisonum
  • Prednitone
  • Promifen
  • Servisone
  • SK-Prednisone
Drug: Bicalutamide
Given PO
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334
Drug: Degarelix
Given via injection
Other Names:
  • Firmagon
  • FE200486
Drug: Flutamide
Given PO
Other Names:
  • Apimid
  • Cebatrol
  • Chimax
  • Cytomid
  • Drogenil
  • Euflex
  • Eulexine
  • Flucinom
  • Flucinome
  • Flugerel
  • Fluken
  • Flulem
  • FLUT
  • Fluta-Gry
  • Flutabene
  • Flutacan
  • Flutamex
  • Flutamin
  • Flutan
  • Flutaplex
  • Fugerel
  • Grisetin
  • Niftolide
  • Oncosal
  • Profamid
  • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
  • Prostacur
  • Prostadirex
  • Prostica
  • Prostogenat
  • Tafenil
  • Tecnoflut
  • Testotard
  • 4'-Nitro-3'-trifluoromethylisobutyranilide
  • SCH 13521
Drug: Nilutamide
Given PO
Other Names:
  • Anandron
  • Nilandron
  • RU-23908
Drug: Goserelin Acetate
Given SC
Other Names:
  • ZDX
  • Zoladex
Drug: Abiraterone
Given PO
Other Names:
  • CB 7598
Drug: Histrelin Acetate
Receive SC
Other Names:
  • Vantas
  • Supprelin
Drug: Leuprolide Acetate
Receive SC or 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
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur
Procedure: Orchiectomy
Undergo bilateral orchiectomy
Other Names:
  • Castration
  • Male Castration
  • Male Gonadectomy
  • orchidectomy
Drug: Triptorelin
injection
Other Names:
  • Decapeptyl
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Drug: Docetaxel
intravenous
Other Names:
  • Taxotere
  • Docecad
  • RP56976
  • Taxotere Injection Concentrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: From date of randomization to date of death due to any cause, assessed up to 8 years
From date of randomization to date of death due to any cause, assessed up to 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Media OS
Time Frame: From date of randomization to date of death due to any cause, assessed up to 8 years
Will compare OS in metastatic prostate cancer patients who received standard systemic therapy (SST) plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.
From date of randomization to date of death due to any cause, assessed up to 8 years
Rate of symptomatic local progression
Time Frame: Up to 8 years
Defined as any of the following events post-randomization: Common Terminology Criteria for Adverse Events version 5 grade >= 2 hematuria, urinary retention, urinary tract obstruction, urinary tract pain, pelvic pain, renal and urinary disorders-other. Will be compared between the treatment arms. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.
Up to 8 years
Progression-free survival (PFS)
Time Frame: From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 8 years
Will be compared between for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.
From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 8 years

Collaborators and Investigators

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

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Brian Chapin, SWOG Cancer Research Network

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)

September 24, 2018

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S1802 (Other Identifier: CTEP)
  • U10CA180888 (U.S. NIH Grant/Contract)
  • NCI-2018-01738 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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