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

RecruitingPhase 3

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

Who can join

Ages 18 and older · Men

Full eligibility criteria
Inclusion Criteria:

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

About the study

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.

What is being tested

Sponsor: SWOG Cancer Research Network · Participants: 1,273 · Started: Sep 24, 2018

Contact the study team

Official record on ClinicalTrials.gov — NCT03678025

Locations in the U.S.

ArizonaBanner MD Anderson Cancer Center, Gilbert
Cancer Center at Saint Joseph's, Phoenix
University of Arizona Cancer Center-North Campus, Tucson
University of Arizona Cancer Center-Orange Grove Campus, Tucson
ArkansasUniversity of Arkansas for Medical Sciences, Little Rock
CaliforniaKaiser Permanente-Deer Valley Medical Center, Antioch
Community Cancer Institute, Clovis
City of Hope Comprehensive Cancer Center, Duarte
Kaiser Permanente Dublin, Dublin
Kaiser Permanente-Fremont, Fremont
Fresno Cancer Center, Fresno
Kaiser Permanente-Fresno, Fresno
UC San Diego Moores Cancer Center, La Jolla
Tibor Rubin VA Medical Center, Long Beach
Los Angeles County-USC Medical Center, Los Angeles
USC / Norris Comprehensive Cancer Center, Los Angeles
Fremont - Rideout Cancer Center, Marysville
Kaiser Permanente-Modesto, Modesto
Kaiser Permanente Oakland-Broadway, Oakland
Kaiser Permanente-Oakland, Oakland
Desert Regional Medical Center, Palm Springs
Stanford Cancer Institute Palo Alto, Palo Alto
Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova
Kaiser Permanente-Redwood City, Redwood City
Kaiser Permanente-Richmond, Richmond
Rohnert Park Cancer Center, Rohnert Park
Kaiser Permanente-Roseville, Roseville
The Permanente Medical Group-Roseville Radiation Oncology, Roseville
Kaiser Permanente Downtown Commons, Sacramento
Kaiser Permanente-South Sacramento, Sacramento
Mercy Cancer Center - Sacramento, Sacramento
South Sacramento Cancer Center, Sacramento
University of California Davis Comprehensive Cancer Center, Sacramento
Kaiser Permanente-San Francisco, San Francisco
Kaiser Permanente-Santa Teresa-San Jose, San Jose
Kaiser Permanente San Leandro, San Leandro
Pacific Central Coast Health Center-San Luis Obispo, San Luis Obispo
Kaiser San Rafael-Gallinas, San Rafael
Kaiser Permanente Medical Center - Santa Clara, Santa Clara
Kaiser Permanente-Santa Rosa, Santa Rosa
Kaiser Permanente Cancer Treatment Center, South San Francisco
Kaiser Permanente-South San Francisco, South San Francisco
Kaiser Permanente-Stockton, Stockton
Gene Upshaw Memorial Tahoe Forest Cancer Center, Truckee
Kaiser Permanente Medical Center-Vacaville, Vacaville
Kaiser Permanente-Vallejo, Vallejo
Kaiser Permanente-Walnut Creek, Walnut Creek
ColoradoUniversity of Colorado Hospital, Aurora
Rocky Mountain Cancer Centers-Boulder, Boulder
Memorial Hospital North, Colorado Springs
UCHealth Memorial Hospital Central, Colorado Springs
Porter Adventist Hospital, Denver
Shaw Cancer Center, Edwards
Poudre Valley Hospital, Fort Collins
North Colorado Medical Center, Greeley
Littleton Adventist Hospital, Littleton
McKee Medical Center, Loveland
Parker Adventist Hospital, Parker
ConnecticutSmilow Cancer Hospital Care Center - Guilford, Guilford
Yale University, New Haven
Stamford Hospital/Bennett Cancer Center, Stamford
Smilow Cancer Hospital Care Center-Trumbull, Trumbull
Smilow Cancer Hospital Care Center - Waterford, Waterford
Veterans Affairs Connecticut Healthcare System-West Haven Campus, West Haven
DelawareChristiana Care Health System-Christiana Hospital, Newark
Helen F Graham Cancer Center, Newark
District of ColumbiaGeorge Washington University Medical Center, Washington D.C.
FloridaMount Sinai Comprehensive Cancer Center at Aventura, Aventura
UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach
Baptist MD Anderson Cancer Center, Jacksonville
UM Sylvester Comprehensive Cancer Center at Kendall, Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami
Mount Sinai Medical Center, Miami Beach
UM Sylvester Comprehensive Cancer Center at Plantation, Plantation
GeorgiaEmory Saint Joseph's Hospital, Atlanta
Emory University Hospital Midtown, Atlanta
Emory University Hospital/Winship Cancer Institute, Atlanta
Grady Health System, Atlanta
Augusta University Medical Center, Augusta
Atlanta VA Medical Center, Decatur
IdahoSaint Alphonsus Cancer Care Center-Caldwell, Caldwell
Saint Alphonsus Cancer Care Center-Nampa, Nampa
Kootenai Clinic Cancer Services - Post Falls, Post Falls
IllinoisRush - Copley Medical Center, Aurora
Illinois CancerCare-Bloomington, Bloomington
Illinois CancerCare-Canton, Canton
Illinois CancerCare-Carthage, Carthage
Rush University Medical Center, Chicago
University of Illinois, Chicago
Decatur Memorial Hospital, Decatur
Crossroads Cancer Center, Effingham
Illinois CancerCare-Eureka, Eureka
Illinois CancerCare-Galesburg, Galesburg
Illinois CancerCare-Kewanee Clinic, Kewanee
Illinois CancerCare-Macomb, Macomb
Loyola University Medical Center, Maywood
Illinois CancerCare-Ottawa Clinic, Ottawa
Illinois CancerCare-Pekin, Pekin
Illinois CancerCare-Peoria, Peoria
Methodist Medical Center of Illinois, Peoria
OSF Saint Francis Medical Center, Peoria
Illinois CancerCare-Peru, Peru
Illinois CancerCare-Princeton, Princeton
Carle Cancer Center, Urbana
IndianaReid Health, Richmond
IowaMcFarland Clinic - Ames, Ames
Iowa Methodist Medical Center, Des Moines
University of Iowa/Holden Comprehensive Cancer Center, Iowa City
KansasUniversity of Kansas Cancer Center, Kansas City
Olathe Health Cancer Center, Olathe
University of Kansas Cancer Center-Overland Park, Overland Park
University of Kansas Hospital-Westwood Cancer Center, Westwood
KentuckySaint Joseph Hospital East, Lexington
Saint Joseph Radiation Oncology Resource Center, Lexington
University of Kentucky/Markey Cancer Center, Lexington (Not yet recruiting)
The James Graham Brown Cancer Center at University of Louisville, Louisville
LouisianaEast Jefferson General Hospital, Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic, Metairie
MaineMaineHealth Coastal Cancer Treatment Center, Bath
Lafayette Family Cancer Center-EMMC, Brewer
Maine Medical Center-Bramhall Campus, Portland
MaineHealth Cancer Care Center of York County, Sanford
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford, Sanford
Maine Medical Center- Scarborough Campus, Scarborough
MichiganSaint Joseph Mercy Hospital, Ann Arbor
University of Michigan Comprehensive Cancer Center, Ann Arbor
Saint Joseph Mercy Brighton, Brighton
Henry Ford Cancer Institute-Downriver, Brownstown
Saint Joseph Mercy Canton, Canton
Saint Joseph Mercy Chelsea, Chelsea
GenesisCare USA - Clarkston, Clarkston
Henry Ford Macomb Hospital-Clinton Township, Clinton Township
Henry Ford Hospital, Detroit
Wayne State University/Karmanos Cancer Institute, Detroit
GenesisCare USA - Farmington Hills, Farmington Hills
Spectrum Health at Butterworth Campus, Grand Rapids
West Michigan Cancer Center, Kalamazoo
Sparrow Hospital, Lansing
GenesisCare USA - Macomb, Macomb
GenesisCare USA - Madison Heights, Madison Heights
21st Century Oncology-Pontiac, Pontiac
Ascension Saint Mary's Hospital, Saginaw
Munson Medical Center, Traverse City
GenesisCare USA - Troy, Troy
Henry Ford West Bloomfield Hospital, West Bloomfield
MinnesotaMercy Hospital, Coon Rapids
Fairview Southdale Hospital, Edina
Unity Hospital, Fridley
Health Partners Inc, Minneapolis
Hennepin County Medical Center, Minneapolis
North Memorial Medical Health Center, Robbinsdale
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park
Regions Hospital, Saint Paul
Saint Francis Regional Medical Center, Shakopee
MissouriSaint Francis Medical Center, Cape Girardeau
Southeast Cancer Center, Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters
University of Missouri - Ellis Fischel, Columbia
Siteman Cancer Center at West County Hospital, Creve Coeur
Freeman Health System, Joplin
University of Kansas Cancer Center - North, Kansas City
Delbert Day Cancer Institute at PCRMC, Rolla
Sainte Genevieve County Memorial Hospital, Sainte Genevieve
CoxHealth South Hospital, Springfield
Mercy Hospital Springfield, Springfield
Mercy Hospital Saint Louis, St Louis
Missouri Baptist Medical Center, St Louis
Siteman Cancer Center at Christian Hospital, St Louis
Siteman Cancer Center-South County, St Louis
Washington University School of Medicine, St Louis
MontanaBillings Clinic Cancer Center, Billings
Bozeman Deaconess Hospital, Bozeman
Saint James Community Hospital and Cancer Treatment Center, Butte
Benefis Healthcare- Sletten Cancer Institute, Great Falls
Kalispell Regional Medical Center, Kalispell
NebraskaNebraska Medicine-Bellevue, Bellevue
Nebraska Medicine-Village Pointe, Omaha
Nebraska Methodist Hospital, Omaha
University of Nebraska Medical Center, Omaha
NevadaComprehensive Cancer Centers of Nevada - Henderson, Henderson
Comprehensive Cancer Centers of Nevada, Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas
Radiation Oncology Centers of Nevada Central, Las Vegas
New HampshireNew Hampshire Oncology Hematology PA-Concord, Concord
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon
Solinsky Center for Cancer Care, Manchester
New JerseyHackensack University Medical Center, Hackensack
New YorkAlbany Medical Center, Albany
Roswell Park Cancer Institute, Buffalo
Noyes Memorial Hospital/Myers Cancer Center, Dansville
Glens Falls Hospital, Glens Falls
NYP/Weill Cornell Medical Center, New York
Upstate Cancer Center Radiation Oncology at Oneida, Oneida
Upstate Cancer Center Radiation Oncology at Oswego, Oswego
Highland Hospital, Rochester
University of Rochester, Rochester
Stony Brook University Medical Center, Stony Brook
State University of New York Upstate Medical University, Syracuse
Montefiore Medical Center - Moses Campus, The Bronx
Montefiore Medical Center-Einstein Campus, The Bronx
North CarolinaAtrium Health Stanly/LCI-Albemarle, Albemarle
Atrium Health Pineville/LCI-Pineville, Charlotte
Atrium Health University City/LCI-University, Charlotte
Carolinas Medical Center/Levine Cancer Institute, Charlotte
Levine Cancer Institute-Ballantyne, Charlotte
Atrium Health Cabarrus/LCI-Concord, Concord
Levine Cancer Institute-Gaston, Gastonia
Margaret R Pardee Memorial Hospital, Hendersonville
Atrium Health Union/LCI-Union, Monroe
CarolinaEast Medical Center, New Bern
OhioCleveland Clinic Mercy Hospital, Canton
Miami Valley Hospital South, Centerville
University of Cincinnati Cancer Center-UC Medical Center, Cincinnati
MetroHealth Medical Center, Cleveland
Ohio State University Comprehensive Cancer Center, Columbus
Miami Valley Hospital North, Dayton
Greater Dayton Cancer Center, Kettering
Kettering Medical Center, Kettering
ProMedica Flower Hospital, Sylvania
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo
University of Cincinnati Cancer Center-West Chester, West Chester
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
PennsylvaniaChambersburg Hospital, Chambersburg
Geisinger Medical Center, Danville
Ephrata Cancer Center, Ephrata
Adams Cancer Center, Gettysburg
Sechler Family Cancer Center, Lebanon
Geisinger Medical Oncology-Lewisburg, Lewisburg
UPMC-Shadyside Hospital, Pittsburgh
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre
WellSpan Health-York Cancer Center, York
South CarolinaPrisma Health Cancer Institute - Spartanburg, Boiling Springs
Medical University of South Carolina, Charleston
Prisma Health Cancer Institute - Eastside, Greenville
Prisma Health Cancer Institute - Faris, Greenville
Saint Francis Cancer Center, Greenville
Prisma Health Cancer Institute - Greer, Greer
Carolina Regional Cancer Center, Myrtle Beach
Levine Cancer Institute-Rock Hill, Rock Hill
Rock Hill Radiation Therapy Center, Rock Hill
Prisma Health Cancer Institute - Seneca, Seneca
TennesseeVanderbilt University/Ingram Cancer Center, Nashville
TexasMD Anderson in The Woodlands, Conroe
Parkland Memorial Hospital, Dallas
UT Southwestern Simmons Cancer Center - RedBird, Dallas
UT Southwestern/Simmons Cancer Center-Dallas, Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth, Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston
Ben Taub General Hospital, Houston
Lyndon Baines Johnson General Hospital, Houston
M D Anderson Cancer Center, Houston
MD Anderson West Houston, Houston
Michael E DeBakey VA Medical Center, Houston
MD Anderson League City, League City
UT Southwestern Clinical Center at Richardson/Plano, Richardson
Audie L Murphy VA Hospital, San Antonio
MD Anderson in Sugar Land, Sugar Land
UtahGeorge E Wahlen Department of Veterans Affairs Medical Center, Salt Lake City
Huntsman Cancer Institute/University of Utah, Salt Lake City
University of Utah Sugarhouse Health Center, Salt Lake City
VermontCentral Vermont Medical Center/National Life Cancer Treatment, Berlin Corners
University of Vermont Medical Center, Burlington
VirginiaBon Secours Saint Francis Medical Center, Midlothian
Bon Secours Cancer Institute at Reynolds Crossing, Richmond
VCU Massey Cancer Center at Stony Point, Richmond
Virginia Commonwealth University/Massey Cancer Center, Richmond
VCU Community Memorial Health Center, South Hill
WashingtonFHCC Overlake, Bellevue
Seattle Cancer Care Alliance at EvergreenHealth, Kirkland
FHCC South Lake Union, Seattle
FHCC at Northwest Hospital, Seattle
University of Washington Medical Center - Montlake, Seattle
West VirginiaWest Virginia University Healthcare, Morgantown
WisconsinLanglade Hospital and Cancer Center, Antigo
Marshfield Medical Center-EC Cancer Center, Eau Claire
Marshfield Medical Center-Marshfield, Marshfield
Froedtert Menomonee Falls Hospital, Menomonee Falls
Medical College of Wisconsin, Milwaukee
Zablocki Veterans Administration Medical Center, Milwaukee
Marshfield Clinic-Minocqua Center, Minocqua
Cancer Center of Western Wisconsin, New Richmond
Drexel Town Square Health Center, Oak Creek
Marshfield Medical Center-Rice Lake, Rice Lake
Ascension Saint Michael's Hospital, Stevens Point
Marshfield Medical Center-River Region at Stevens Point, Stevens Point
Aspirus Regional Cancer Center, Wausau
Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend
Diagnostic and Treatment Center, Weston
Marshfield Medical Center - Weston, Weston
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.