Castration Levels of TestosteronePhase 3NCT03678025
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
A Phase 3 study testing Abiraterone, Bicalutamide and Degarelix in people with Castration Levels of Testosterone and Metastatic Prostatic Adenocarcinoma, run by SWOG Cancer Research Network at 338 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration Levels of Testosterone, Metastatic Prostatic Adenocarcinoma, Stage IV Prostate Cancer AJCC v8
- What is being tested?
- Abiraterone, Bicalutamide and Degarelix
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,273 participants
- Where
- 338 sitesin 5 countries
- Study dates
- 24 Sep 2018to 1 Oct 2036
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 24Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
338 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
304 sites in 5 countries
United States300 sites, 267 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12208
Site Public Contact, 518-262-5513
Badar M. Mian
- Recruiting
Atrium Health Stanly/LCI-Albemarle
Albemarle, North Carolina, 28002
Site Public Contact, 800-804-9376
Earle F. Burgess
- Suspended
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125
Samuel D. Kaffenberger
- Recruiting
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Christopher S. Platta
- Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Active, not recruiting
Mission Hospital
Asheville, North Carolina, 28801
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Site Public Contact, 404-489-9164
Shreyas Joshi
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Shreyas Joshi
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Shreyas Joshi
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Shreyas Joshi
- Recruiting
Augusta University Medical Center
Augusta, Georgia, 30912
Site Public Contact, 706-721-2388, ga_cares@augusta.edu
Sharad A. Ghamande
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Paul D. Maroni
- Recruiting
Rush - Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, Cancer.Research@rushcopley.com
Sinisa Stanic
- Recruiting
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Site Public Contact, 305-674-2625, yenrique@msmc.com
Michael A. Schwartz
- Active, not recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
- Recruiting
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Matthew H. Hayn
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Benjamin A. Teply
- Recruiting
FHCC Overlake
Bellevue, Washington, 98004
Site Public Contact, 425-454-2148
Jason Comer
- Recruiting
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Site Public Contact, 802-225-5400
Nataniel H. Lester-Coll
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-241-6251
Ki Y. Chung
- Recruiting
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Site Public Contact, 303-777-2663, info@westernstatesncorp.org
Nicholas DiBella
- Recruiting
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
Site Public Contact, 800-987-3005
Sarah J. Sinclair
- Recruiting
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Gurkamal S. Chatta
- Active, not recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Site Public Contact, 802-656-4101, rpo@uvm.edu
Nataniel H. Lester-Coll
- Recruiting
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Site Public Contact, 406-723-2621
Troy A. Fiddler
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
John M. Schallenkamp
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Joseph Mercy Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708
Site Public Contact, 888-293-4673
Mitchell Haut
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-651-5550
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Sherif F. Yacoub
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
David T. Marshall
- Recruiting
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Site Public Contact, 800-804-9376
Earle F. Burgess
- Recruiting
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210
Site Public Contact, 980-442-2000
Earle F. Burgess
- Recruiting
Atrium Health University City/LCI-University
Charlotte, North Carolina, 28262
Site Public Contact, 800-804-9376
Earle F. Burgess
- Recruiting
Levine Cancer Institute-Ballantyne
Charlotte, North Carolina, 28277
Site Public Contact, 800-804-9376
Earle F. Burgess
- Recruiting
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Christopher M. Reynolds
- Active, not recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Site Public Contact, 312-942-5498, clinical_trials@rush.edu
Srinivas Vourganti
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Daniel Moreira
- Active, not recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Abhinav Sidana
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Jeff M. Michalski
- Recruiting
GenesisCare USA - Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 941-833-5700, Rudi.Ross@usa.genesiscare.com
Frank A. Vicini
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
Site Public Contact, 216-778-8526, dstrater@metrohealth.org
William Tse
- Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Recruiting
Community Cancer Institute
Clovis, California, 93611
Site Public Contact, 559-387-1827
Uzair B. Chaudhary
- Suspended
University Oncology Associates
Clovis, California, 93611
- Recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Site Public Contact, 719-365-2406
Paul D. Maroni
- Recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
Site Public Contact, 719-364-6700
Paul D. Maroni
- Recruiting
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212
Site Public Contact, 573-882-7440
Kushal Naha
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Steven K. Clinton
- Recruiting
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
Site Public Contact, 603-224-2556
Douglas J. Weckstein
- Recruiting
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Site Public Contact, 800-804-9376
Earle F. Burgess
- Recruiting
MD Anderson in The Woodlands
Conroe, Texas, 77384
Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org
Brian F. Chapin
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
Site Public Contact, 305-243-2647
Chad R. Ritch
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Jeff M. Michalski
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu
Suzanne M. Cole
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
Suzanne M. Cole
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Suzanne M. Cole
- Recruiting
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York, 14437
Site Public Contact, WCICTOresearch@urmc.rochester.edu
Paul M. Barr
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Ahmad Hanif
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Atlanta VA Medical Center
Decatur, Georgia, 30033
Site Public Contact, 404-321-6111 ext. 7632
Wayne B. Harris
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
Site Public Contact, 305-243-2647
Chad R. Ritch
- Recruiting
Porter Adventist Hospital
Denver, Colorado, 80210
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Joshua Lukenbill
- Recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Elisabeth I. Heath
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Active, not recruiting
Wentworth-Douglass Hospital
Dover, New Hampshire, 03820
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Tanya B. Dorff
- Recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
Site Public Contact, 877-642-4691
Andrea L. Harzstark
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Shaw Cancer Center
Edwards, Colorado, 81632
Site Public Contact, 970-569-7429
Patricia H. Hardenbergh
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522
Site Public Contact, 717-721-4840
Sherif F. Yacoub
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
GenesisCare USA - Farmington Hills
Farmington Hills, Michigan, 48334
Site Public Contact, 941-833-5700, Rudi.Ross@usa.genesiscare.com
Frank A. Vicini
- Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Site Public Contact, 970-297-6150
Paul D. Maroni
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Suzanne M. Cole
- Recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Fresno Cancer Center
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Kaiser Permanente-Fresno
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Unity Hospital
Fridley, Minnesota, 55432
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Levine Cancer Institute-Gaston
Gastonia, North Carolina, 28054
Site Public Contact, 800-804-9376
Earle F. Burgess
- Recruiting
Adams Cancer Center
Gettysburg, Pennsylvania, 17325
Site Public Contact, 877-441-7957
Sherif F. Yacoub
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Site Public Contact, 602-747-9738
Chinedu Mmeje
- Recruiting
Glens Falls Hospital
Glens Falls, New York, 12801
Site Public Contact, 518-926-6700
Nataniel H. Lester-Coll
- Recruiting
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
North Colorado Medical Center
Greeley, Colorado, 80631
Site Public Contact, 970-810-3046, BMDACCResearchCOMailbox@bannerhealth.com
Supriya Jain
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-241-6251
Ki Y. Chung
- Recruiting
Saint Francis Cancer Center
Greenville, South Carolina, 29607
Site Public Contact, 864-603-6213, melissa_beckman@bshsi.org
Jennifer Vogel
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-241-6251
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-241-6251
Ki Y. Chung
- Active, not recruiting
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Preston C. Sprenkle
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Site Public Contact, 201-996-2879
Robert S. Alter
- Recruiting
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
Site Public Contact, 828-696-4716, pardeecancerresearch@unchealth.unc.edu
Praveen Vashist
- Recruiting
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
Site Public Contact, 713-566-5000
Brian F. Chapin
- Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Site Public Contact, 713-798-1354, burton@bcm.edu
Martha P. Mims
- Recruiting
Ben Taub General Hospital
Houston, Texas, 77030
Site Public Contact, 713-873-2000
Martha P. Mims
- Active, not recruiting
Houston Methodist Hospital
Houston, Texas, 77030
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org
Brian F. Chapin
- Recruiting
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
Site Public Contact, 800-553-2278
Aihua E. Yen
- Recruiting
MD Anderson West Houston
Houston, Texas, 77079
Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org
Brian F. Chapin
- Active, not recruiting
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
Yousef Zakharia
- Suspended
University of Mississippi Medical Center
Jackson, Mississippi, 39216
- Recruiting
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Site Public Contact, 904-202-7468
Jonathan J. Melquist
- Recruiting
Freeman Health System
Joplin, Missouri, 64804
Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com
Jay W. Carlson
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen J. Yost
- Recruiting
Kalispell Regional Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
William Parker
- Recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
William Parker
- Recruiting
Greater Dayton Cancer Center
Kettering, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Kettering Medical Center
Kettering, Ohio, 45429
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington, 98034
Site Public Contact, 425-899-6000
Eric W. Dean
- Active, not recruiting
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
Aditya Bagrodia
- Active, not recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
- Recruiting
Sparrow Hospital
Lansing, Michigan, 48912
Site Public Contact, 517-364-9400
Christopher M. Reynolds
- Recruiting
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
Site Public Contact, 702-384-0013, research@sncrf.org
John A. Ellerton
- Recruiting
MD Anderson League City
League City, Texas, 77573
Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org
Brian F. Chapin
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Rodwell Mabaera
- Recruiting
Sechler Family Cancer Center
Lebanon, Pennsylvania, 17042
Site Public Contact, 717-741-8303, doxenberg@wellspan.org
Sherif F. Yacoub
- Recruiting
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Site Public Contact, 570-374-8555, HemonCCTrials@geisinger.edu
Ahmad Hanif
- Recruiting
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
Site Public Contact, 859-629-7169, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Saint Joseph Hospital East
Lexington, Kentucky, 40509
Site Public Contact, 859-629-7169, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Not yet recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Patrick J. Hensley
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Site Public Contact, 501-686-8274
Shi-Ming Tu
- Recruiting
Littleton Adventist Hospital
Littleton, Colorado, 80122
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Suspended
Logan Regional Hospital
Logan, Utah, 84321
- Recruiting
Tibor Rubin VA Medical Center
Long Beach, California, 90822
Site Public Contact, 562-826-8000
Greg Gin
- Recruiting
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
Siamak Daneshmand
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
Siamak Daneshmand
- Recruiting
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Site Public Contact, 502-562-3429
Scott R. Silva
- Recruiting
McKee Medical Center
Loveland, Colorado, 80539
Site Public Contact, 970-810-3046, BMDACCResearchCOMailbox@bannerhealth.com
Supriya Jain
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
GenesisCare USA - Macomb
Macomb, Michigan, 48044
Site Public Contact, 941-833-5700, Rudi.Ross@usa.genesiscare.com
Frank A. Vicini
- Recruiting
GenesisCare USA - Madison Heights
Madison Heights, Michigan, 48071
Site Public Contact, 941-833-5700, Rudi.Ross@usa.genesiscare.com
Frank A. Vicini
- Active, not recruiting
Elliot Hospital
Manchester, New Hampshire, 03103
- Recruiting
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103
Site Public Contact, 800-339-6484
Douglas J. Weckstein
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Fremont - Rideout Cancer Center
Marysville, California, 95901
Site Public Contact, 530-749-4400
Richard K. Valicenti
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Site Public Contact, 708-226-4357
Ami Badami
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
Scott Johnson
- Recruiting
East Jefferson General Hospital
Metairie, Louisiana, 70006
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Scott E. Delacroix
- Recruiting
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Scott E. Delacroix
- Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Site Public Contact, 305-243-2647
Chad R. Ritch
- Recruiting
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
Site Public Contact, 305-243-2647
Chad R. Ritch
- Recruiting
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Site Public Contact, 305-674-2625, yenrique@msmc.com
Michael A. Schwartz
- Recruiting
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
William J. Irvin
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Scott Johnson
- Recruiting
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295
Site Public Contact, 888-469-6614
Elizabeth M. Gore
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Health Partners Inc
Minneapolis, Minnesota, 55454
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Kaiser Permanente-Modesto
Modesto, California, 95356
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Atrium Health Union/LCI-Union
Monroe, North Carolina, 28112
Site Public Contact, 980-442-2000
Earle F. Burgess
- Recruiting
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Danh C. Pham
- Suspended
Intermountain Medical Center
Murray, Utah, 84107
- Recruiting
Carolina Regional Cancer Center
Myrtle Beach, South Carolina, 29577
Site Public Contact, 877-460-2657
Frank A. Vicini
- Recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Site Public Contact, 800-811-8480
Kerry R. Schaffer
- Recruiting
CarolinaEast Medical Center
New Bern, North Carolina, 28561
Site Public Contact, 252-634-6589, lharrison@carolinaeasthealth.com
Sarah B. Carroll
- Recruiting
Yale University
New Haven, Connecticut, 06520
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Preston C. Sprenkle
- Recruiting
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
NYP/Weill Cornell Medical Center
New York, New York, 10065
Site Public Contact, 212-746-1848
Douglas Scherr
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
Scott Johnson
- Recruiting
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Kaiser Permanente-Oakland
Oakland, California, 94611
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Suspended
McKay-Dee Hospital Center
Ogden, Utah, 84403
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Kelly L. Stratton
- Recruiting
Olathe Health Cancer Center
Olathe, Kansas, 66061
Site Public Contact, 913-355-8000, Jeni.wakefield@olathehealth.org
William Parker
- Recruiting
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Site Public Contact, 402-354-5144
Ralph J. Hauke
- Recruiting
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
Site Public Contact, 402-559-5600
Benjamin A. Teply
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Benjamin A. Teply
- Recruiting
Upstate Cancer Center Radiation Oncology at Oneida
Oneida, New York, 13421
Site Public Contact, 315-464-3603, BinghamE@upstate.edu
Gennady Bratslavsky
- Active, not recruiting
Orlando Health Cancer Institute
Orlando, Florida, 32806
- Recruiting
Upstate Cancer Center Radiation Oncology at Oswego
Oswego, New York, 13126
Site Public Contact, 315-464-3603, BinghamE@upstate.edu
Gennady Bratslavsky
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
William Parker
- Recruiting
Desert Regional Medical Center
Palm Springs, California, 92262
Site Public Contact, 760-416-4730
Amir Lavaf
- Recruiting
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
Site Public Contact, 650-498-7061, ccto-office@stanford.edu
Geoffrey A. Sonn
- Recruiting
Parker Adventist Hospital
Parker, Colorado, 80138
Site Public Contact, 719-776-6550, ResearchTracking@Centura.Org
Shahzad Siddique
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Withdrawn
Temple University Hospital
Philadelphia, Pennsylvania, 19140
- Recruiting
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Site Public Contact, 602-406-0777, CancerInstitute@DignityHealth.org
Shahzad Siddique
- Suspended
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
- Recruiting
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Benjamin J. Davies
- Recruiting
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-621-2334
Benjamin J. Davies
- Recruiting
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
Site Public Contact, 305-243-2647
Chad R. Ritch
- Recruiting
21st Century Oncology-Pontiac
Pontiac, Michigan, 48341
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Christopher M. Reynolds
- Recruiting
Maine Medical Center-Bramhall Campus
Portland, Maine, 04102
Site Public Contact, 207-885-7565
Matthew H. Hayn
- Active, not recruiting
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
- Active, not recruiting
Oregon Health and Science University
Portland, Oregon, 97239
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Utah Valley Regional Medical Center
Provo, Utah, 84604
- Recruiting
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Kaiser Permanente-Redwood City
Redwood City, California, 94063
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080
Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu
Suzanne M. Cole
- Recruiting
Kaiser Permanente-Richmond
Richmond, California, 94801
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Reid Health
Richmond, Indiana, 47374
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230
Site Public Contact, 804-893-8978, Anne_caramella@bshsi.org
William J. Irvin
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Site Public Contact, ctoclinops@vcu.edu
Asit K. Paul
- Recruiting
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Site Public Contact, CTOclinops@vcu.edu
Asit K. Paul
- Suspended
Riverton Hospital
Riverton, Utah, 84065
- Recruiting
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Suspended
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
- Recruiting
Highland Hospital
Rochester, New York, 14620
Site Public Contact, 585-341-8113
Paul M. Barr
- Recruiting
University of Rochester
Rochester, New York, 14642
Site Public Contact, 585-275-5830
Paul M. Barr
- Recruiting
Rock Hill Radiation Therapy Center
Rock Hill, South Carolina, 29730
Site Public Contact, 800-804-9376
Earle F. Burgess
- Recruiting
Levine Cancer Institute-Rock Hill
Rock Hill, South Carolina, 29732
Site Public Contact, 800-804-9376
Earle F. Burgess
- Recruiting
Rohnert Park Cancer Center
Rohnert Park, California, 94928
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401
Site Public Contact, 573-458-7504, research@phelpshealth.org
Jay W. Carlson
- Recruiting
Kaiser Permanente-Roseville
Roseville, California, 95661
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Kaiser Permanente Downtown Commons
Sacramento, California, 95814
Site Public Contact, 877-642-4691, kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Mercy Cancer Center - Sacramento
Sacramento, California, 95816
Site Public Contact, 916-556-3301, OncologyResearch@DignityHealth.org
Shahzad Siddique
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Site Public Contact, 916-734-3089
Richard K. Valicenti
- Recruiting
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
South Sacramento Cancer Center
Sacramento, California, 95823
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601
Site Public Contact, 989-907-8411, lori.srebinski@ascension.org
Christopher M. Reynolds
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Alejandro Sanchez
- Suspended
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Alejandro Sanchez
- Suspended
LDS Hospital
Salt Lake City, Utah, 84143
- Recruiting
George E Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, 84148
Site Public Contact, 801-582-1565
Sumati V. Gupta
- Recruiting
Audie L Murphy VA Hospital
San Antonio, Texas, 78229
Site Public Contact, 877-469-5300
Michael A. Liss
- Active, not recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
- Recruiting
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Kaiser Permanente San Leandro
San Leandro, California, 94577
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401
Site Public Contact, 805-219-4673, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Kaiser San Rafael-Gallinas
San Rafael, California, 94903
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073
Site Public Contact, 207-459-1600
Matthew H. Hayn
- Recruiting
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine, 04073
Site Public Contact, LLemire@mmc.org
Matthew H. Hayn
- Recruiting
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074
Site Public Contact, 207-396-8090, wrighd@mmc.org
Matthew H. Hayn
- Suspended
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
- Recruiting
FHCC South Lake Union
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Daniel W. Lin
- Recruiting
FHCC at Northwest Hospital
Seattle, Washington, 98133
Site Public Contact, 206-606-5800
Nikhil V. Kamat
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Site Public Contact, 800-804-8824
Daniel W. Lin
- Recruiting
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Site Public Contact, 864-241-6251
Ki Y. Chung
- Recruiting
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
VCU Community Memorial Health Center
South Hill, Virginia, 23970
Site Public Contact, nemer.elmouallem@vcuhealth.org
Asit K. Paul
- Recruiting
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Mercy Hospital Springfield
Springfield, Missouri, 65804
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
CoxHealth South Hospital
Springfield, Missouri, 65807
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Jeff M. Michalski
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Jeff M. Michalski
- Recruiting
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Jeff M. Michalski
- Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Site Public Contact, 314-251-7066
Jay W. Carlson
- Suspended
Saint George Regional Medical Center
St. George, Utah, 84770
- Recruiting
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, 06904
Site Public Contact, 203-323-8944
Anthony P. Gulati
- Recruiting
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin, 54481
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Christopher S. Platta
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Seth O. Fagbemi
- Recruiting
Kaiser Permanente-Stockton
Stockton, California, 95210
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Site Public Contact, 800-862-2215
Massimiliano Spaliviero
- Recruiting
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org
Brian F. Chapin
- Suspended
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226
- Recruiting
ProMedica Flower Hospital
Sylvania, Ohio, 43560
Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org
Jeffrey A. Forquer
Chile1 site, 1 recruiting
- Recruiting
Instituto Nacional del Cancer
Independence, 8380455
Site Public Contact, info@incancer.cl
Annerleim Walton-diaz
Colombia1 site, 1 recruiting
- Recruiting
Instituto Nacional De Cancerologia
Bogotá, 99999
Site Public Contact, 57 1 3341111
Marino Cabrera
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional De Cancerologia de Mexico
Mexico City, Tlalpan, 14080
Site Public Contact, (52) 5628-0400
Miguel A. Jimenez-Rios
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, 5001
Site Public Contact, 41 62 838 60 50
Oliver Riesterer
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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:
- 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.
- 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.
- Conditions
- Castration Levels of Testosterone, Metastatic Prostatic Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- Being tested
- Abiraterone, Bicalutamide, Degarelix, Docetaxel, Flutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbirateroneDrug
Also called CB 7598
Given PO
BicalutamideDrug
Also called Casodex, Cosudex, ICI 176,334, ICI 176334
Given PO
DegarelixDrug
Also called FE200486, Firmagon
Given via injection
DocetaxelDrug
Also called Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
intravenous
FlutamideDrug
Also called 4'-Nitro-3'-trifluoromethylisobutyranilide, Apimid, Cebatrol, Chimax
Given PO
Goserelin AcetateDrug
Also called ZDX, Zoladex
Given SC
Histrelin AcetateDrug
Also called Supprelin, Vantas
Receive SC
Leuprolide AcetateDrug
Also called A-43818, Abbott 43818, Abbott-43818, Carcinil
Receive SC or IM
NilutamideDrug
Also called Anandron, Nilandron, RU-23908
Given PO
OrchiectomyProcedure or surgery
Also called Castration, Male Castration, Male Gonadectomy, orchidectomy
Undergo bilateral orchiectomy
PrednisoneDrug
Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation
Standard radiation
Radical ProstatectomyProcedure or surgery
Also called Prostatovesiculectomy
Standard surgery
TriptorelinDrug
Also called 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532
injection
| Study group | Role | What they receive |
|---|---|---|
| Arm I (SST) | Active comparator | Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Receives: Drug: Abiraterone; Drug: Bicalutamide; Drug: Degarelix; Drug: Flutamide; Drug: Goserelin Acetate; Drug: Histrelin Acetate; Drug: Leuprolide Acetate; Drug: Nilutamide; Procedure: Orchiectomy; Other: Quality-of-Life Assessment; Drug: Triptorelin |
| Arm II (SST, prostatectomy or radiation therapy) | Experimental | 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. Receives: Drug: Abiraterone; Drug: Bicalutamide; Drug: Degarelix; Drug: Flutamide; Drug: Goserelin Acetate; Drug: Histrelin Acetate; Drug: Leuprolide Acetate; Drug: Nilutamide; Procedure: Orchiectomy; Other: Quality-of-Life Assessment; Radiation: Radiation Therapy; Procedure: Radical Prostatectomy; Drug: Triptorelin |
| Step 1 (pre-randomization) | Active comparator | Standard treatment data collection prior to randomization Receives: Drug: Abiraterone; Drug: Bicalutamide; Drug: Degarelix; Drug: Docetaxel; Drug: Flutamide; Drug: Goserelin Acetate; Drug: Histrelin Acetate; Drug: Leuprolide Acetate; Drug: Nilutamide; Procedure: Orchiectomy; Drug: Prednisone; Other: Quality-of-Life Assessment; Drug: Triptorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: From date of randomization to date of death due to any cause, assessed up to 8 years
Secondary outcomes (3)
Media OS
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.
Measured: From date of randomization to date of death due to any cause, assessed up to 8 years
Rate of symptomatic local progression
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.
Measured: Up to 8 years
Progression-free survival (PFS)
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.
Measured: From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start24 Sep 2018
- Primary completion1 Apr 2033 (estimated)
- Study completion1 Oct 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration Levels of TestosteroneStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,273 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian Chapin, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678025
- Sponsor's protocol ID
- S1802
- Other IDs
- NCI-2018-01738, S1802, S1802, U10CA180888
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2018
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03678025
- Acronym / sponsor ID
- S1802
- Conditions
- Castration Levels of Testosterone, Metastatic Prostatic Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,273 participants (estimated)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 1 Apr 2033 (estimated)
- Study completion
- 1 Oct 2036 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (SST) | Active comparator | Drug: Abiraterone, Drug: Bicalutamide, Drug: Degarelix, Drug: Flutamide, Drug: Goserelin Acetate, Drug: Histrelin Acetate, Drug: Leuprolide Acetate, Drug: Nilutamide, Procedure: Orchiectomy, Other: Quality-of-Life Assessment, Drug: TriptorelinParticipants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. |
| Arm II (SST, prostatectomy or radiation therapy) | Experimental | Drug: Abiraterone, Drug: Bicalutamide, Drug: Degarelix, Drug: Flutamide, Drug: Goserelin Acetate, Drug: Histrelin Acetate, Drug: Leuprolide Acetate, Drug: Nilutamide, Procedure: Orchiectomy, Other: Quality-of-Life Assessment, Radiation: Radiation Therapy, Procedure: Radical Prostatectomy, Drug: TriptorelinParticipants 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. |
| Step 1 (pre-randomization) | Active comparator | Drug: Abiraterone, Drug: Bicalutamide, Drug: Degarelix, Drug: Docetaxel, Drug: Flutamide, Drug: Goserelin Acetate, Drug: Histrelin Acetate, Drug: Leuprolide Acetate, Drug: Nilutamide, Procedure: Orchiectomy, Drug: Prednisone, Other: Quality-of-Life Assessment, Drug: TriptorelinStandard treatment data collection prior to randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbirateroneAlso: CB 7598Given PO | Drug | Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization) |
| BicalutamideAlso: Casodex, Cosudex, ICI 176,334, ICI 176334Given PO | Drug | Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization) |
| DegarelixAlso: FE200486, FirmagonGiven via injection | Drug | Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization) |
| DocetaxelAlso: Docecad, RP56976, Taxotere, Taxotere Injection Concentrateintravenous | Drug | Step 1 (pre-randomization) |
| FlutamideAlso: 4'-Nitro-3'-trifluoromethylisobutyranilide, Apimid, Cebatrol, ChimaxGiven PO | Drug | Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization) |
| Goserelin AcetateAlso: ZDX, ZoladexGiven SC | Drug | Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization) |
| Histrelin AcetateAlso: Supprelin, VantasReceive SC | Drug | Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization) |
| Leuprolide AcetateAlso: A-43818, Abbott 43818, Abbott-43818, CarcinilReceive SC or IM | Drug | Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization) |
| NilutamideAlso: Anandron, Nilandron, RU-23908Given PO | Drug | Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization) |
| OrchiectomyAlso: Castration, Male Castration, Male Gonadectomy, orchidectomyUndergo bilateral orchiectomy | Procedure or surgery | Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization) |
| PrednisoneAlso: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, CortancylGiven PO | Drug | Step 1 (pre-randomization) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, irradiationStandard radiation | Radiation | Arm II (SST, prostatectomy or radiation therapy) |
| Radical ProstatectomyAlso: ProstatovesiculectomyStandard surgery | Procedure or surgery | Arm II (SST, prostatectomy or radiation therapy) |
| TriptorelinAlso: 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532injection | Drug | Arm I (SST), Arm II (SST, prostatectomy or radiation therapy), Step 1 (pre-randomization) |
Primary outcome
Overall survival (OS)
Time frame: From date of randomization to date of death due to any cause, assessed up to 8 years
3 secondary outcomes
Media OS
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Related trials for Castration Levels of Testosterone
Active, not recruitingPhase 2
Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel
Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma
Active, not recruitingPhase 2
Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Chapin principal investigator
SWOG Cancer Research Network
338 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abiraterone, Bicalutamide and Degarelix in people with Castration Levels of Testosterone and Metastatic Prostatic Adenocarcinoma, run by SWOG Cancer Research Network at 338 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 338 sites in United States, Chile, Colombia, Mexico, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Sparks, MAT (2106148808 ext. 1004, dsparks@swog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From date of randomization to date of death due to any cause, assessed up to 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.