RecruitingPhase 3NCT03678025

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

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

Sponsor

SWOG Cancer Research Network

Enrollment

1,273 participants

Start Date

Sep 24, 2018

Study Type

INTERVENTIONAL

Conditions

Stage IV Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Castration Levels of Testosterone Metastatic Prostatic Adenocarcinoma

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding targeted local treatments (such as radiation or surgery) to specific cancer sites alongside standard systemic therapy (hormone therapy or chemotherapy) improves survival for men with prostate cancer that has spread to a limited number of locations in the body (metastatic prostate cancer). **You may be eligible if...** - You have been diagnosed with prostate cancer (adenocarcinoma) confirmed by biopsy - Your cancer has spread to other parts of the body (metastatic) - You are starting or continuing standard systemic treatment for metastatic prostate cancer - You are in adequate overall health - You have a limited number of visible cancer spots that can be targeted with radiation or surgery **You may NOT be eligible if...** - Your cancer is a rare type other than adenocarcinoma (such as small cell, sarcomatoid, or squamous cell) - You have too many metastatic cancer sites to target - You have had prior chemotherapy for metastatic disease in certain circumstances - You are unable to tolerate the planned systemic treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbiraterone

Given PO

DRUGBicalutamide

Given PO

DRUGDegarelix

Given via injection

DRUGDocetaxel

intravenous

DRUGFlutamide

Given PO

DRUGGoserelin Acetate

Given SC

DRUGHistrelin Acetate

Receive SC

DRUGLeuprolide Acetate

Receive SC or IM

DRUGNilutamide

Given PO

PROCEDUREOrchiectomy

Undergo bilateral orchiectomy

DRUGPrednisone

Given PO

OTHERQuality-of-Life Assessment

Ancillary studies

RADIATIONRadiation Therapy

Standard radiation

PROCEDURERadical Prostatectomy

Standard surgery

DRUGTriptorelin

injection

Locations(338)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Community Cancer Institute

Clovis, California, United States

University Oncology Associates

Clovis, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Fresno Cancer Center

Fresno, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Tibor Rubin VA Medical Center

Long Beach, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

South Sacramento Cancer Center

Sacramento, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Memorial Hospital North

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Shaw Cancer Center

Edwards, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

North Colorado Medical Center

Greeley, Colorado, United States

Littleton Adventist Hospital

Littleton, Colorado, United States

McKee Medical Center

Loveland, Colorado, United States

Parker Adventist Hospital

Parker, Colorado, United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Stamford Hospital/Bennett Cancer Center

Stamford, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States

Veterans Affairs Connecticut Healthcare System-West Haven Campus

West Haven, Connecticut, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

MedStar Georgetown University Hospital

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

MedStar Washington Hospital Center

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

George Washington University Medical Center

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

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Rush - Copley Medical Center

Aurora, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Southwest Illinois Health Services LLP

Swansea, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Reid Health

Richmond, Indiana, United States

McFarland Clinic - Ames

Ames, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Olathe Health Cancer Center

Olathe, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, United States

Saint Joseph Hospital East

Lexington, Kentucky, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, United States

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

Maine Medical Center-Bramhall Campus

Portland, Maine, United States

MaineHealth Cancer Care Center of York County

Sanford, Maine, United States

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford

Sanford, Maine, United States

Maine Medical Center- Scarborough Campus

Scarborough, Maine, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Saint Joseph Mercy Brighton

Brighton, Michigan, United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Saint Joseph Mercy Canton

Canton, Michigan, United States

Saint Joseph Mercy Chelsea

Chelsea, Michigan, United States

GenesisCare USA - Clarkston

Clarkston, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

GenesisCare USA - Farmington Hills

Farmington Hills, Michigan, United States

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Sparrow Hospital

Lansing, Michigan, United States

GenesisCare USA - Macomb

Macomb, Michigan, United States

GenesisCare USA - Madison Heights

Madison Heights, Michigan, United States

21st Century Oncology-Pontiac

Pontiac, Michigan, United States

Ascension Saint Mary's Hospital

Saginaw, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

GenesisCare USA - Troy

Troy, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Health Partners Inc

Minneapolis, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

University of Missouri - Ellis Fischel

Columbia, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Freeman Health System

Joplin, Missouri, United States

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

CoxHealth South Hospital

Springfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Radiation Oncology Centers of Nevada Central