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

NCT03678025 | Recruiting Phase 3 DMC FDA Device

• 3 other identifiers: S1802NCI-2018-01738U10CA180888
• Study Type: interventional
• Target: 1,273
• Locations: 5 countries
• Sites: 338

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  From date of randomization to date of death due to any cause, assessed up to 8 years

Secondary Outcomes (3)

• Media OS

  From date of randomization to date of death due to any cause, assessed up to 8 years

• Rate of symptomatic local progression

  Up to 8 years

• Progression-free survival (PFS)

  From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 8 years

Study Arms (3)

Arm I (SST)

ACTIVE COMPARATOR

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

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.

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

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

Interventions

Abiraterone DRUG

Given PO

Also known as: CB 7598

Arm I (SST); Arm II (SST, prostatectomy or radiation therapy); Step 1 (pre-randomization)

Bicalutamide DRUG

Given PO

Also known as: Casodex, Cosudex, ICI 176,334, ICI 176334

Arm I (SST); Arm II (SST, prostatectomy or radiation therapy); Step 1 (pre-randomization)

Degarelix DRUG

Given via injection

Also known as: FE200486, Firmagon

Arm I (SST); Arm II (SST, prostatectomy or radiation therapy); Step 1 (pre-randomization)

Docetaxel DRUG

intravenous

Also known as: Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

Step 1 (pre-randomization)

Flutamide DRUG

Given PO

Also known as: 4'-Nitro-3'-trifluoromethylisobutyranilide, Apimid, Cebatrol, Chimax, Cytomid, Drogenil, Euflex, Eulexine, Flucinom, Flucinome, Flugerel, Fluken, Flulem, FLUT, Fluta-Gry, Flutabene, Flutacan, Flutamex, Flutamin, Flutan, Flutaplex, Fugerel, Grisetin, Niftolide, Oncosal, Profamid, Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-, Prostacur, Prostadirex, Prostica, Prostogenat, SCH 13521, Tafenil, Tecnoflut, Testotard

Arm I (SST); Arm II (SST, prostatectomy or radiation therapy); Step 1 (pre-randomization)

Goserelin Acetate DRUG

Given SC

Also known as: ZDX, Zoladex

Arm I (SST); Arm II (SST, prostatectomy or radiation therapy); Step 1 (pre-randomization)

Histrelin Acetate DRUG

Receive SC

Also known as: Supprelin, Vantas

Arm I (SST); Arm II (SST, prostatectomy or radiation therapy); Step 1 (pre-randomization)

Leuprolide Acetate DRUG

Receive SC or IM

Also known as: A-43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Procren, Procrin, Prostap, TAP-144, Trenantone, Uno-Enantone, Viadur

Arm I (SST); Arm II (SST, prostatectomy or radiation therapy); Step 1 (pre-randomization)

Nilutamide DRUG

Given PO

Also known as: Anandron, Nilandron, RU-23908

Arm I (SST); Arm II (SST, prostatectomy or radiation therapy); Step 1 (pre-randomization)

Orchiectomy PROCEDURE

Undergo bilateral orchiectomy

Also known as: Castration, Male Castration, Male Gonadectomy, orchidectomy

Arm I (SST); Arm II (SST, prostatectomy or radiation therapy); Step 1 (pre-randomization)

Prednisone DRUG

Given PO

Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisonum, Prednitone, Promifen, Servisone, SK-Prednisone

Step 1 (pre-randomization)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (SST); Arm II (SST, prostatectomy or radiation therapy); Step 1 (pre-randomization)

Radiation Therapy RADIATION

Standard radiation

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Arm II (SST, prostatectomy or radiation therapy)

Radical Prostatectomy PROCEDURE

Standard surgery

Also known as: Prostatovesiculectomy

Arm II (SST, prostatectomy or radiation therapy)

Triptorelin DRUG

injection

Also known as: 6-D-Tryptophan-LH-RH, 6-D-Tryptophanluteinizing Hormone-releasing Factor, AY-25650, CL-118,532, Decapeptyl, Detryptoreline

Arm I (SST); Arm II (SST, prostatectomy or radiation therapy); Step 1 (pre-randomization)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (338)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004, United States

RECRUITING

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

SUSPENDED

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

SUSPENDED

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, 85704, United States

RECRUITING

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531, United States

RECRUITING

Community Cancer Institute

Clovis, California, 93611, United States

RECRUITING

University Oncology Associates

Clovis, California, 93611, United States

SUSPENDED

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

Kaiser Permanente Dublin

Dublin, California, 94568, United States

RECRUITING

Kaiser Permanente-Fremont

Fremont, California, 94538, United States

RECRUITING

Fresno Cancer Center

Fresno, California, 93720, United States

RECRUITING

Kaiser Permanente-Fresno

Fresno, California, 93720, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Tibor Rubin VA Medical Center

Long Beach, California, 90822, United States

RECRUITING

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Fremont - Rideout Cancer Center

Marysville, California, 95901, United States

RECRUITING

Kaiser Permanente-Modesto

Modesto, California, 95356, United States

RECRUITING

Kaiser Permanente Oakland-Broadway

Oakland, California, 94611, United States

RECRUITING

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

RECRUITING

Desert Regional Medical Center

Palm Springs, California, 92262, United States

RECRUITING

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

RECRUITING

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, 95670, United States

RECRUITING

Kaiser Permanente-Redwood City

Redwood City, California, 94063, United States

RECRUITING

Kaiser Permanente-Richmond

Richmond, California, 94801, United States

RECRUITING

Rohnert Park Cancer Center

Rohnert Park, California, 94928, United States

RECRUITING

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

RECRUITING

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, 95678, United States

RECRUITING

Kaiser Permanente Downtown Commons

Sacramento, California, 95814, United States

RECRUITING

Mercy Cancer Center - Sacramento

Sacramento, California, 95816, United States

RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

RECRUITING

South Sacramento Cancer Center

Sacramento, California, 95823, United States

RECRUITING

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

RECRUITING

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

RECRUITING

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

RECRUITING

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, 93401, United States

RECRUITING

Kaiser San Rafael-Gallinas

San Rafael, California, 94903, United States

RECRUITING

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

RECRUITING

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States

RECRUITING

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080, United States

RECRUITING

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

RECRUITING

Kaiser Permanente-Stockton

Stockton, California, 95210, United States

RECRUITING

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States

RECRUITING

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688, United States

RECRUITING

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

RECRUITING

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

RECRUITING

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304, United States

RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, 80920, United States

RECRUITING

Porter Adventist Hospital

Denver, Colorado, 80210, United States

RECRUITING

Shaw Cancer Center

Edwards, Colorado, 81632, United States

RECRUITING

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

RECRUITING

North Colorado Medical Center

Greeley, Colorado, 80631, United States

RECRUITING

Littleton Adventist Hospital

Littleton, Colorado, 80122, United States

RECRUITING

McKee Medical Center

Loveland, Colorado, 80539, United States

RECRUITING

Parker Adventist Hospital

Parker, Colorado, 80138, United States

RECRUITING

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Stamford Hospital/Bennett Cancer Center

Stamford, Connecticut, 06904, United States

RECRUITING

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

RECRUITING

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States

RECRUITING

Veterans Affairs Connecticut Healthcare System-West Haven Campus

West Haven, Connecticut, 06516, United States

RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

RECRUITING

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

ACTIVE NOT RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

ACTIVE NOT RECRUITING

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States

RECRUITING

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176, United States

RECRUITING

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

RECRUITING

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

ACTIVE NOT RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324, United States

RECRUITING

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Augusta University Medical Center

Augusta, Georgia, 30912, United States

RECRUITING

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

RECRUITING

Rush - Copley Medical Center

Aurora, Illinois, 60504, United States

RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

ACTIVE NOT RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

ACTIVE NOT RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

RECRUITING

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

RECRUITING

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

RECRUITING

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

RECRUITING

Southwest Illinois Health Services LLP

Swansea, Illinois, 62226, United States

SUSPENDED

Carle Cancer Center

Urbana, Illinois, 61801, United States

RECRUITING

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

ACTIVE NOT RECRUITING

Reid Health

Richmond, Indiana, 47374, United States

RECRUITING

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

Olathe Health Cancer Center

Olathe, Kansas, 66061, United States

RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, 40504, United States

RECRUITING

Saint Joseph Hospital East

Lexington, Kentucky, 40509, United States

RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

NOT YET RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

East Jefferson General Hospital

Metairie, Louisiana, 70006, United States

RECRUITING

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006, United States

RECRUITING

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, 04530, United States

RECRUITING

Lafayette Family Cancer Center-EMMC

Brewer, Maine, 04412, United States

RECRUITING

Maine Medical Center-Bramhall Campus

Portland, Maine, 04102, United States

RECRUITING

MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073, United States

RECRUITING

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford

Sanford, Maine, 04073, United States

RECRUITING

Maine Medical Center- Scarborough Campus

Scarborough, Maine, 04074, United States

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

ACTIVE NOT RECRUITING

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

ACTIVE NOT RECRUITING

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

RECRUITING

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Saint Joseph Mercy Brighton

Brighton, Michigan, 48114, United States

RECRUITING

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States

RECRUITING

Saint Joseph Mercy Canton

Canton, Michigan, 48188, United States

RECRUITING

Saint Joseph Mercy Chelsea

Chelsea, Michigan, 48118, United States

RECRUITING

GenesisCare USA - Clarkston

Clarkston, Michigan, 48346, United States

RECRUITING

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States

RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

GenesisCare USA - Farmington Hills

Farmington Hills, Michigan, 48334, United States

RECRUITING

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503, United States

RECRUITING

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

RECRUITING

Sparrow Hospital

Lansing, Michigan, 48912, United States

RECRUITING

GenesisCare USA - Macomb

Macomb, Michigan, 48044, United States

RECRUITING

GenesisCare USA - Madison Heights

Madison Heights, Michigan, 48071, United States

RECRUITING

21st Century Oncology-Pontiac

Pontiac, Michigan, 48341, United States

RECRUITING

Ascension Saint Mary's Hospital

Saginaw, Michigan, 48601, United States

RECRUITING

Munson Medical Center

Traverse City, Michigan, 49684, United States

RECRUITING

GenesisCare USA - Troy

Troy, Michigan, 48098, United States

RECRUITING

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

RECRUITING

Unity Hospital

Fridley, Minnesota, 55432, United States

RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

Health Partners Inc

Minneapolis, Minnesota, 55454, United States

RECRUITING

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

SUSPENDED

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

SUSPENDED

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

RECRUITING

Southeast Cancer Center

Cape Girardeau, Missouri, 63703, United States

RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States

RECRUITING

University of Missouri - Ellis Fischel

Columbia, Missouri, 65212, United States

RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

RECRUITING

Freeman Health System

Joplin, Missouri, 64804, United States

RECRUITING

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

RECRUITING

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401, United States

RECRUITING

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

RECRUITING

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

RECRUITING

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

RECRUITING

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States

RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

RECRUITING

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

RECRUITING

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

RECRUITING

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States

RECRUITING

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405, United States

RECRUITING

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

RECRUITING

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123, United States

RECRUITING

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

RECRUITING

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, 89052, United States

RECRUITING

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, 89106, United States

RECRUITING

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, 89128, United States

RECRUITING

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, 89144, United States

RECRUITING

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

RECRUITING

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89169, United States

RECRUITING

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, 03301, United States

RECRUITING

Wentworth-Douglass Hospital

Dover, New Hampshire, 03820, United States

ACTIVE NOT RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Elliot Hospital

Manchester, New Hampshire, 03103, United States

ACTIVE NOT RECRUITING

Solinsky Center for Cancer Care

Manchester, New Hampshire, 03103, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Holy Name Hospital

Teaneck, New Jersey, 07666, United States

ACTIVE NOT RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Noyes Memorial Hospital/Myers Cancer Center

Dansville, New York, 14437, United States

RECRUITING

Glens Falls Hospital

Glens Falls, New York, 12801, United States

RECRUITING

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States

ACTIVE NOT RECRUITING

NYP/Weill Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

Upstate Cancer Center Radiation Oncology at Oneida

Oneida, New York, 13421, United States

RECRUITING

Upstate Cancer Center Radiation Oncology at Oswego

Oswego, New York, 13126, United States

RECRUITING

Highland Hospital

Rochester, New York, 14620, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

ACTIVE NOT RECRUITING

Atrium Health Stanly/LCI-Albemarle

Albemarle, North Carolina, 28002, United States

RECRUITING

Mission Hospital

Asheville, North Carolina, 28801, United States

ACTIVE NOT RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

RECRUITING

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, 28210, United States

RECRUITING

Atrium Health University City/LCI-University

Charlotte, North Carolina, 28262, United States

RECRUITING

Levine Cancer Institute-Ballantyne

Charlotte, North Carolina, 28277, United States

RECRUITING

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, 28025, United States

RECRUITING

Levine Cancer Institute-Gaston

Gastonia, North Carolina, 28054, United States

RECRUITING

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

RECRUITING

Atrium Health Union/LCI-Union

Monroe, North Carolina, 28112, United States

RECRUITING

CarolinaEast Medical Center

New Bern, North Carolina, 28561, United States

RECRUITING

Cleveland Clinic Mercy Hospital

Canton, Ohio, 44708, United States

RECRUITING

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

RECRUITING

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

RECRUITING

Greater Dayton Cancer Center

Kettering, Ohio, 45409, United States

RECRUITING

Kettering Medical Center

Kettering, Ohio, 45429, United States

RECRUITING

ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

RECRUITING

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606, United States

RECRUITING

University of Toledo

Toledo, Ohio, 43614, United States

SUSPENDED

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

ACTIVE NOT RECRUITING

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States

ACTIVE NOT RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

ACTIVE NOT RECRUITING

Chambersburg Hospital

Chambersburg, Pennsylvania, 17201, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

Ephrata Cancer Center

Ephrata, Pennsylvania, 17522, United States

RECRUITING

Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States

RECRUITING

Sechler Family Cancer Center

Lebanon, Pennsylvania, 17042, United States

RECRUITING

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States

RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

WITHDRAWN

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

RECRUITING

WellSpan Health-York Cancer Center

York, Pennsylvania, 17403, United States

RECRUITING

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

RECRUITING

Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

RECRUITING

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

RECRUITING

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

RECRUITING

Carolina Regional Cancer Center

Myrtle Beach, South Carolina, 29577, United States

RECRUITING

Rock Hill Radiation Therapy Center

Rock Hill, South Carolina, 29730, United States

RECRUITING

Levine Cancer Institute-Rock Hill

Rock Hill, South Carolina, 29732, United States

RECRUITING

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

RECRUITING

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

RECRUITING

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, 75237, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

Lyndon Baines Johnson General Hospital

Houston, Texas, 77026-1967, United States

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Ben Taub General Hospital

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

RECRUITING

MD Anderson West Houston

Houston, Texas, 77079, United States

RECRUITING

MD Anderson League City

League City, Texas, 77573, United States

RECRUITING

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080, United States

RECRUITING

Audie L Murphy VA Hospital

San Antonio, Texas, 78229, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

ACTIVE NOT RECRUITING

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

RECRUITING

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

ACTIVE NOT RECRUITING

American Fork Hospital / Huntsman Intermountain Cancer Center

American Fork, Utah, 84003, United States

SUSPENDED

Sandra L Maxwell Cancer Center

Cedar City, Utah, 84720, United States

SUSPENDED

Logan Regional Hospital

Logan, Utah, 84321, United States

SUSPENDED

Intermountain Medical Center

Murray, Utah, 84107, United States

SUSPENDED

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

SUSPENDED

Utah Valley Regional Medical Center

Provo, Utah, 84604, United States

SUSPENDED

Riverton Hospital

Riverton, Utah, 84065, United States

SUSPENDED

University of Utah Sugarhouse Health Center

Salt Lake City, Utah, 84106, United States

RECRUITING

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, 84106, United States

SUSPENDED

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

LDS Hospital

Salt Lake City, Utah, 84143, United States

SUSPENDED

George E Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, 84148, United States

RECRUITING

Saint George Regional Medical Center

St. George, Utah, 84770, United States

SUSPENDED

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, 05602, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, 23114, United States

RECRUITING

Bon Secours Cancer Institute at Reynolds Crossing

Richmond, Virginia, 23230, United States

RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States

RECRUITING

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

VCU Community Memorial Health Center

South Hill, Virginia, 23970, United States

RECRUITING

FHCC Overlake

Bellevue, Washington, 98004, United States

RECRUITING

Seattle Cancer Care Alliance at EvergreenHealth

Kirkland, Washington, 98034, United States

RECRUITING

FHCC South Lake Union

Seattle, Washington, 98109, United States

RECRUITING

FHCC at Northwest Hospital

Seattle, Washington, 98133, United States

RECRUITING

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

RECRUITING

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686, United States

ACTIVE NOT RECRUITING

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409, United States

RECRUITING

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States

RECRUITING

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

ACTIVE NOT RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

RECRUITING

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Zablocki Veterans Administration Medical Center

Milwaukee, Wisconsin, 53295, United States

RECRUITING

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548, United States

RECRUITING

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017, United States

RECRUITING

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154, United States

RECRUITING

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

RECRUITING

Ascension Saint Michael's Hospital

Stevens Point, Wisconsin, 54481, United States

RECRUITING

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

RECRUITING

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095, United States

RECRUITING

Diagnostic and Treatment Center

Weston, Wisconsin, 54476, United States

RECRUITING

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

RECRUITING

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

RECRUITING

Instituto Nacional del Cancer

Independence, 8380455, Chile

RECRUITING

Instituto Nacional De Cancerologia

Bogotá, 99999, Colombia

RECRUITING

Instituto Nacional De Cancerologia de Mexico

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

Kantonsspital Aarau

Aarau, 5001, Switzerland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abiraterone; bicalutamide; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Docetaxel; Flutamide; Salicylic Acid; Goserelin; histrelin; Leuprolide; luprolide acetate gel depot; nilutamide; Orchiectomy; Castration; Prednisone; deltacortene; prednylidene; Radiotherapy; Radiation; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Anilides; Amides; Aniline Compounds; Amines; Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Phenols; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Therapeutics; Physical Phenomena

Study Officials

• Brian Chapin

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Sparks, MAT

CONTACT

2106148808; dsparks@swog.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: September 24, 2018
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2031
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

ME (1); CL (1); CO (1); US (334); CH (1)