Standard Systemic Therapy with or without Definitive Treatment in Treating Participants with Metastatic Prostate Cancer

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Status: Active

Description

This phase III trial studies whether the addition of definitive treatment (radiation or surgical removal) of the primary tumor to standard systemic therapy for patients with prostate cancer, may help prevent the cancer from the spreading to other parts of their body. Removing the prostate by either surgery or radiation therapy in addition to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

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 technetium bone scan, and either computed tomography (CT) of abdomen and pelvis or a magnetic resonance imaging (MRI) of pelvis within 42 days prior to starting standard systemic therapy, with evidence of metastatic disease on at least one scan. 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, imaging (bone scan and one of the following: CT of abdomen & pelvis, MRI of abdomen & pelvis, CT of abdomen & MRI of pelvis) 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.

Locations & Contacts

Arizona

Phoenix
Mayo Clinic Hospital
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Tucson
University of Arizona Cancer Center-North Campus
Status: Active
Contact: Site Public Contact
Phone: 800-327-2873
University of Arizona Cancer Center-Orange Grove Campus
Status: Active
Contact: Site Public Contact
Phone: 520-694-8900

Arkansas

Little Rock
University of Arkansas for Medical Sciences
Status: Active
Contact: Site Public Contact
Phone: 501-686-8274

California

Antioch
Kaiser Permanente-Deer Valley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Dublin
Kaiser Permanente Dublin
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Fremont
Kaiser Permanente-Fremont
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Fresno
Fresno Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-Fresno
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 858-822-5354
Email: cancercto@ucsd.edu
Los Angeles
Los Angeles County-USC Medical Center
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
Marysville
Fremont - Rideout Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 530-749-4400
Modesto
Kaiser Permanente-Modesto
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Oakland
Kaiser Permanente Oakland-Broadway
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-Oakland
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Contact: Site Public Contact
Phone: 650-498-7061
Email: ccto-office@stanford.edu
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Redwood City
Kaiser Permanente-Redwood City
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Richmond
Kaiser Permanente-Richmond
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Rohnert Park
Rohnert Park Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
Kaiser Permanente-Roseville
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
The Permanente Medical Group-Roseville Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Kaiser Permanente Downtown Commons
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: kpoct@kp.org
Kaiser Permanente-South Sacramento
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South Sacramento Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
San Francisco
Kaiser Permanente-San Francisco
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Leandro
Kaiser Permanente San Leandro
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Rafael
Kaiser San Rafael-Gallinas
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Rosa
Kaiser Permanente-Santa Rosa
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-South San Francisco
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Stockton
Kaiser Permanente-Stockton
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 530-582-6450
Vacaville
Kaiser Permanente Medical Center-Vacaville
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vallejo
Kaiser Permanente-Vallejo
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Walnut Creek
Kaiser Permanente-Walnut Creek
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Memorial Hospital North
Status: Active
Contact: Site Public Contact
Phone: 719-364-6700
UCHealth Memorial Hospital Central
Status: Active
Contact: Site Public Contact
Phone: 719-365-2406
Fort Collins
Poudre Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 970-297-6150

Connecticut

New Haven
Yale University
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

District of Columbia

Washington
MedStar Washington Hospital Center
Status: Active
Contact: Site Public Contact
Phone: 202-877-8839

Florida

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Miami
UM Sylvester Comprehensive Cancer Center at Kendall
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
UF Cancer Center at Orlando Health
Status: Active
Contact: Site Public Contact
Phone: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com
Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: Active
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 404-778-1868

Idaho

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Illinois

Aurora
Rush - Copley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com
Chicago
Rush University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
University of Illinois
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Decatur
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Peoria
Methodist Medical Center of Illinois
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Swansea
Southwest Illinois Health Services LLP
Status: Active
Contact: Site Public Contact
Phone: 618-236-1000
Email: lynns@thecancercenter.com
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu

Iowa

Ames
McFarland Clinic PC - Ames
Status: Active
Contact: Site Public Contact
Phone: 515-239-4734
Email: ksoder@mcfarlandclinic.com

Kansas

Kansas City
University of Kansas Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Overland Park
University of Kansas Cancer Center-Overland Park
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu

Kentucky

Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: Active
Contact: Site Public Contact
Phone: 502-562-3429

Louisiana

Metairie
East Jefferson General Hospital
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu

Maine

Bath
MaineHealth Coastal Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Brewer
Lafayette Family Cancer Center-EMMC
Status: Active
Contact: Site Public Contact
Phone: 800-987-3005
Portland
Maine Medical Center-Bramhall Campus
Status: Active
Contact: Site Public Contact
Phone: 207-885-7565
Sanford
MaineHealth Cancer Care Center of York County
Status: Active
Contact: Site Public Contact
Phone: 207-459-1600
Scarborough
Maine Medical Center- Scarborough Campus
Status: Active
Contact: Site Public Contact
Phone: 207-396-8090
Email: wrighd@mmc.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu

Massachusetts

Burlington
Lahey Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 781-744-3421
Email: cancerclinicaltrials@lahey.org

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Brighton
Saint Joseph Mercy Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Brownstown
Henry Ford Cancer Institute-Downriver
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Canton
Saint Joseph Mercy Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Chelsea
Saint Joseph Mercy Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Detroit
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org

Minnesota

Fridley
Unity Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Minneapolis
Health Partners Inc
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Paul
Regions Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Shakopee
Saint Francis Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Mississippi

Jackson
University of Mississippi Medical Center
Status: Active
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 573-651-5550
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Kansas City
The University of Kansas Cancer Center-North
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Saint Louis
Missouri Baptist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Siteman Cancer Center-South County
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu

Montana

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Omaha
Nebraska Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144
University of Nebraska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 402-559-6941
Email: unmcrsa@unmc.edu

Nevada

Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Las Vegas
Comprehensive Cancer Centers of Nevada
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Central Valley
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Northwest
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada-Summerlin
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Hampshire

Concord
New Hampshire Oncology Hematology PA-Concord
Status: Active
Contact: Site Public Contact
Phone: 603-224-2556
Hooksett
New Hampshire Oncology Hematology PA-Hooksett
Status: Active
Contact: Site Public Contact
Phone: 800-339-6484

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
New York
NYP / Weill Cornell Medical Center
Status: Active
Contact: Site Public Contact
Phone: 212-746-1848
Rochester
Highland Hospital
Status: Active
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Site Public Contact
Phone: 315-464-5476

North Carolina

Asheville
Mission Hospital Inc-Memorial Campus
Status: Active
Contact: Site Public Contact
Phone: 828-213-4150
Email: leslie.verner@msj.org
New Bern
CarolinaEast Medical Center
Status: Active
Contact: Site Public Contact
Phone: 252-634-6589
Email: lharrison@carolinaeasthealth.com

Ohio

Canton
Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-293-4673
Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Kettering
Kettering Medical Center
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
West Chester
University Pointe
Status: Active
Contact: Site Public Contact
Email: clinicaltrials@ucphysicians.com

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-413-2150
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-220-4937
Email: cancer@lhs.org
Oregon Health and Science University
Status: Active
Contact: Site Public Contact
Phone: 503-494-1080
Email: trials@ohsu.edu

Pennsylvania

Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: Site Public Contact
Phone: 412-647-8073
UPMC-Shadyside Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-621-2334

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
Greenville
Prisma Health Cancer Institute - Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Prisma Health Cancer Institute - Faris
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Greer
Prisma Health Cancer Institute - Greer
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Seneca
Prisma Health Cancer Institute - Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Houston
Ben Taub General Hospital
Status: Active
Contact: Site Public Contact
Phone: 713-873-2000
Lyndon Baines Johnson General Hospital
Status: Active
Contact: Site Public Contact
Phone: 713-566-5000
M D Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org

Utah

American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 801-855-4100
Email: officeofresearch@imail.org
Cedar City
Sandra L Maxwell Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 435-868-5680
Email: officeofresearch@imail.org
Logan
Logan Regional Hospital
Status: Active
Contact: Site Public Contact
Phone: 435-716-6400
Email: officeofresearch@imail.org
Murray
Intermountain Medical Center
Status: Active
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Ogden
McKay-Dee Hospital Center
Status: Active
Contact: Site Public Contact
Phone: 801-387-7426
Email: officeofresearch@imail.org
Provo
Utah Valley Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 801-357-7965
Email: officeofresearch@imail.org
Riverton
Riverton Hospital
Status: Active
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Saint George
Dixie Medical Center Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 435-688-4167
Email: officeofresearch@imail.org
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
LDS Hospital
Status: Active
Contact: Site Public Contact
Phone: 801-408-1347
Email: officeofresearch@imail.org
Utah Cancer Specialists-Salt Lake City
Status: Active
Contact: Site Public Contact
Phone: 801-933-6070
Email: officeofresearch@imail.org

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 804-628-1914
Email: klcampbell@vcu.edu

Washington

Seattle
University of Washington Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-804-8824
Vancouver
Legacy Salmon Creek Hospital
Status: Active
Contact: Site Public Contact
Phone: 503-413-2150

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 715-623-9869
Email: Juli.Alford@aspirus.org
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
La Crosse
Mayo Clinic Health System-Franciscan Healthcare
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Marshfield
Marshfield Medical Center-Marshfield
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Menomonee Falls
Community Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 262-257-5100
Milwaukee
Medical College of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-805-3666
Minocqua
Marshfield Clinic-Minocqua Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Rice Lake
Marshfield Medical Center-Rice Lake
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Stevens Point
Marshfield Clinic Stevens Point Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Wausau
Aspirus Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-405-6866
West Bend
The Alyce and Elmore Kraemer Cancer Care Center
Status: Active
Contact: Site Public Contact
Phone: 866-680-0505
Weston
Diagnostic and Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 888-799-3989
Email: oncology.clinical.trials@marshfieldresearch.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

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

III. To compare progression-free survival (PFS) between the two treatment arms.

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

QUALITY OF LIFE OBJECTIVES:

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

OTHER OBJECTIVES:

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

OUTLINE:

INDUCTION: Participants receive 1 of 6 acceptable forms of SST for 22-28 weeks.

I. Participants undergo a bilateral orchiectomy.

II. Participants receive goserelin acetate subcutaneously (SC) every 28 days or 12 weeks, histrelin acetate SC every 12 months, leuprolide acetate SC or intramuscularly (IM) every 1, 3, 4, or 6 months, and triptorelin every 1, 3, or 6 months.

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

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

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

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

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

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

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

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

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
SWOG

Principal Investigator
Brian Francis Chapin

Trial IDs

Primary ID S1802
Secondary IDs NCI-2018-01738
Clinicaltrials.gov ID NCT03678025