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 is this study for? Adult patients with metastatic castration-resistant prostate cancer
Status: Recruiting
Location: See all (326) locations...
Intervention Type: Procedure, Drug, Other, Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
Recruiting
Little Rock
Arizona
Banner MD Anderson Cancer Center
Recruiting
Gilbert
Cancer Center at Saint Joseph's
Recruiting
Phoenix
Mayo Clinic Hospital in Arizona
Recruiting
Phoenix
Mayo Clinic in Arizona
Recruiting
Scottsdale
University of Arizona Cancer Center-North Campus
Recruiting
Tucson
University of Arizona Cancer Center-Orange Grove Campus
Recruiting
Tucson
California
Kaiser Permanente-Deer Valley Medical Center
Recruiting
Antioch
Community Cancer Institute
Recruiting
Clovis
University Oncology Associates
Suspended
Clovis
City of Hope Comprehensive Cancer Center
Recruiting
Duarte
Kaiser Permanente Dublin
Recruiting
Dublin
Kaiser Permanente-Fremont
Recruiting
Fremont
Fresno Cancer Center
Recruiting
Fresno
Kaiser Permanente-Fresno
Recruiting
Fresno
UC San Diego Moores Cancer Center
Recruiting
La Jolla
Tibor Rubin VA Medical Center
Recruiting
Long Beach
Los Angeles County-USC Medical Center
Recruiting
Los Angeles
USC / Norris Comprehensive Cancer Center
Recruiting
Los Angeles
Fremont - Rideout Cancer Center
Recruiting
Marysville
Kaiser Permanente-Modesto
Recruiting
Modesto
Kaiser Permanente Oakland-Broadway
Recruiting
Oakland
Kaiser Permanente-Oakland
Recruiting
Oakland
Desert Regional Medical Center
Recruiting
Palm Springs
Stanford Cancer Institute Palo Alto
Recruiting
Palo Alto
Kaiser Permanente-Rancho Cordova Cancer Center
Recruiting
Rancho Cordova
Kaiser Permanente-Redwood City
Recruiting
Redwood City
Kaiser Permanente-Richmond
Recruiting
Richmond
Rohnert Park Cancer Center
Recruiting
Rohnert Park
Kaiser Permanente-Roseville
Recruiting
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Recruiting
Roseville
Kaiser Permanente Downtown Commons
Recruiting
Sacramento
Kaiser Permanente-South Sacramento
Recruiting
Sacramento
South Sacramento Cancer Center
Recruiting
Sacramento
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento
Kaiser Permanente-San Francisco
Recruiting
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
Recruiting
San Jose
Kaiser Permanente San Leandro
Recruiting
San Leandro
Kaiser San Rafael-Gallinas
Recruiting
San Rafael
Kaiser Permanente Medical Center - Santa Clara
Recruiting
Santa Clara
Kaiser Permanente-Santa Rosa
Recruiting
Santa Rosa
Kaiser Permanente Cancer Treatment Center
Recruiting
South San Francisco
Kaiser Permanente-South San Francisco
Recruiting
South San Francisco
Kaiser Permanente-Stockton
Recruiting
Stockton
Gene Upshaw Memorial Tahoe Forest Cancer Center
Recruiting
Truckee
Kaiser Permanente Medical Center-Vacaville
Recruiting
Vacaville
Kaiser Permanente-Vallejo
Recruiting
Vallejo
Kaiser Permanente-Walnut Creek
Recruiting
Walnut Creek
Colorado
University of Colorado Hospital
Recruiting
Aurora
Rocky Mountain Cancer Centers-Boulder
Recruiting
Boulder
Memorial Hospital North
Recruiting
Colorado Springs
UCHealth Memorial Hospital Central
Recruiting
Colorado Springs
Porter Adventist Hospital
Recruiting
Denver
Shaw Cancer Center
Recruiting
Edwards
Poudre Valley Hospital
Recruiting
Fort Collins
North Colorado Medical Center
Recruiting
Greeley
Littleton Adventist Hospital
Recruiting
Littleton
McKee Medical Center
Recruiting
Loveland
Parker Adventist Hospital
Recruiting
Parker
Connecticut
Smilow Cancer Hospital Care Center - Guiford
Recruiting
Guilford
Yale University
Recruiting
New Haven
Stamford Hospital/Bennett Cancer Center
Recruiting
Stamford
Smilow Cancer Hospital Care Center-Trumbull
Recruiting
Trumbull
Smilow Cancer Hospital Care Center - Waterford
Recruiting
Waterford
Veterans Affairs Connecticut Healthcare System-West Haven Campus
Recruiting
West Haven
Washington, D.c.
George Washington University Medical Center
Recruiting
Washington
MedStar Georgetown University Hospital
Active, not recruiting
Washington
MedStar Washington Hospital Center
Active, not recruiting
Washington
Delaware
Christiana Care Health System-Christiana Hospital
Recruiting
Newark
Helen F Graham Cancer Center
Recruiting
Newark
Florida
Mount Sinai Comprehensive Cancer Center at Aventura
Recruiting
Aventura
UM Sylvester Comprehensive Cancer Center at Coral Gables
Recruiting
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Recruiting
Deerfield Beach
Baptist MD Anderson Cancer Center
Recruiting
Jacksonville
UM Sylvester Comprehensive Cancer Center at Kendall
Recruiting
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Recruiting
Miami
Mount Sinai Medical Center
Recruiting
Miami Beach
Orlando Health Cancer Institute
Active, not recruiting
Orlando
UM Sylvester Comprehensive Cancer Center at Plantation
Recruiting
Plantation
Georgia
Emory Saint Joseph's Hospital
Recruiting
Atlanta
Emory University Hospital Midtown
Recruiting
Atlanta
Emory University Hospital/Winship Cancer Institute
Recruiting
Atlanta
Grady Health System
Recruiting
Atlanta
Augusta University Medical Center
Recruiting
Augusta
Atlanta VA Medical Center
Recruiting
Decatur
Iowa
McFarland Clinic PC - Ames
Recruiting
Ames
Iowa Methodist Medical Center
Recruiting
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Recruiting
Iowa City
Idaho
Saint Alphonsus Cancer Care Center-Caldwell
Recruiting
Caldwell
Saint Alphonsus Medical Center-Nampa
Recruiting
Nampa
Kootenai Clinic Cancer Services - Post Falls
Recruiting
Post Falls
Illinois
Rush - Copley Medical Center
Recruiting
Aurora
Illinois CancerCare-Bloomington
Recruiting
Bloomington
Illinois CancerCare-Canton
Recruiting
Canton
Illinois CancerCare-Carthage
Recruiting
Carthage
Northwestern University
Active, not recruiting
Chicago
Rush University Medical Center
Recruiting
Chicago
University of Chicago Comprehensive Cancer Center
Recruiting
Chicago
University of Illinois
Recruiting
Chicago
Decatur Memorial Hospital
Recruiting
Decatur
Crossroads Cancer Center
Recruiting
Effingham
Illinois CancerCare-Eureka
Recruiting
Eureka
Illinois CancerCare-Galesburg
Recruiting
Galesburg
Illinois CancerCare-Kewanee Clinic
Recruiting
Kewanee
Illinois CancerCare-Macomb
Recruiting
Macomb
Loyola University Medical Center
Recruiting
Maywood
Illinois CancerCare-Ottawa Clinic
Recruiting
Ottawa
Illinois CancerCare-Pekin
Recruiting
Pekin
Illinois CancerCare-Peoria
Recruiting
Peoria
Methodist Medical Center of Illinois
Recruiting
Peoria
OSF Saint Francis Medical Center
Recruiting
Peoria
Illinois CancerCare-Peru
Recruiting
Peru
Illinois CancerCare-Princeton
Recruiting
Princeton
Southwest Illinois Health Services LLP
Suspended
Swansea
Carle Cancer Center
Recruiting
Urbana
Indiana
Indiana University/Melvin and Bren Simon Cancer Center
Active, not recruiting
Indianapolis
Reid Health
Recruiting
Richmond
Kansas
University of Kansas Cancer Center
Recruiting
Kansas City
Olathe Health Cancer Center
Recruiting
Olathe
University of Kansas Cancer Center-Overland Park
Recruiting
Overland Park
University of Kansas Hospital-Westwood Cancer Center
Recruiting
Westwood
Kentucky
Saint Joseph Hospital East
Recruiting
Lexington
Saint Joseph Radiation Oncology Resource Center
Recruiting
Lexington
The James Graham Brown Cancer Center at University of Louisville
Recruiting
Louisville
Louisiana
East Jefferson General Hospital
Recruiting
Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Recruiting
Metairie
Massachusetts
Lahey Hospital and Medical Center
Active, not recruiting
Burlington
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Active, not recruiting
Baltimore
Maine
MaineHealth Coastal Cancer Treatment Center
Recruiting
Bath
Lafayette Family Cancer Center-EMMC
Recruiting
Brewer
Maine Medical Center-Bramhall Campus
Recruiting
Portland
MaineHealth Cancer Care Center of York County
Recruiting
Sanford
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Recruiting
Sanford
Maine Medical Center- Scarborough Campus
Recruiting
Scarborough
Michigan
Saint Joseph Mercy Hospital
Recruiting
Ann Arbor
University of Michigan Comprehensive Cancer Center
Recruiting
Ann Arbor
Saint Joseph Mercy Brighton
Recruiting
Brighton
Henry Ford Cancer Institute-Downriver
Recruiting
Brownstown
Saint Joseph Mercy Canton
Recruiting
Canton
Saint Joseph Mercy Chelsea
Recruiting
Chelsea
GenesisCare USA - Clarkston
Recruiting
Clarkston
Henry Ford Macomb Hospital-Clinton Township
Recruiting
Clinton Township
Henry Ford Hospital
Recruiting
Detroit
Wayne State University/Karmanos Cancer Institute
Recruiting
Detroit
GenesisCare USA - Farmington Hills
Recruiting
Farmington Hills
Spectrum Health at Butterworth Campus
Recruiting
Grand Rapids
West Michigan Cancer Center
Recruiting
Kalamazoo
Sparrow Hospital
Recruiting
Lansing
GenesisCare USA - Macomb
Recruiting
Macomb
GenesisCare USA - Madison Heights
Recruiting
Madison Heights
21st Century Oncology-Pontiac
Recruiting
Pontiac
Ascension Saint Mary's Hospital
Recruiting
Saginaw
Munson Medical Center
Recruiting
Traverse City
GenesisCare USA - Troy
Recruiting
Troy
Henry Ford West Bloomfield Hospital
Recruiting
West Bloomfield
Minnesota
Mercy Hospital
Recruiting
Coon Rapids
Fairview Southdale Hospital
Recruiting
Edina
Unity Hospital
Recruiting
Fridley
Health Partners Inc
Recruiting
Minneapolis
Hennepin County Medical Center
Recruiting
Minneapolis
North Memorial Medical Health Center
Recruiting
Robbinsdale
Mayo Clinic in Rochester
Recruiting
Rochester
Park Nicollet Clinic - Saint Louis Park
Recruiting
Saint Louis Park
Regions Hospital
Recruiting
Saint Paul
Saint Francis Regional Medical Center
Recruiting
Shakopee
Missouri
Saint Francis Medical Center
Recruiting
Cape Girardeau
Southeast Cancer Center
Recruiting
Cape Girardeau
University of Missouri - Ellis Fischel
Recruiting
Columbia
Siteman Cancer Center at West County Hospital
Recruiting
Creve Coeur
Freeman Health System
Recruiting
Joplin
University of Kansas Cancer Center - North
Recruiting
Kansas City
Mercy Hospital Saint Louis
Recruiting
Saint Louis
Missouri Baptist Medical Center
Recruiting
Saint Louis
Siteman Cancer Center at Christian Hospital
Recruiting
Saint Louis
Siteman Cancer Center-South County
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Recruiting
Saint Peters
Sainte Genevieve County Memorial Hospital
Recruiting
Sainte Genevieve
CoxHealth South Hospital
Recruiting
Springfield
Mercy Hospital Springfield
Recruiting
Springfield
Mississippi
University of Mississippi Medical Center
Recruiting
Jackson
Montana
Billings Clinic Cancer Center
Recruiting
Billings
Bozeman Deaconess Hospital
Recruiting
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Recruiting
Butte
Benefis Healthcare- Sletten Cancer Institute
Recruiting
Great Falls
Kalispell Regional Medical Center
Recruiting
Kalispell
North Carolina
Atrium Health Stanly/LCI-Albemarle
Recruiting
Albemarle
Mission Hospital
Active, not recruiting
Asheville
Atrium Health Pineville/LCI-Pineville
Recruiting
Charlotte
Atrium Health University City/LCI-University
Recruiting
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Recruiting
Charlotte
Levine Cancer Institute-Ballantyne
Recruiting
Charlotte
Atrium Health Cabarrus/LCI-Concord
Recruiting
Concord
Levine Cancer Institute-Gaston
Recruiting
Gastonia
Margaret R Pardee Memorial Hospital
Recruiting
Hendersonville
Atrium Health Union/LCI-Union
Recruiting
Monroe
CarolinaEast Medical Center
Recruiting
New Bern
Nebraska
Nebraska Methodist Hospital
Recruiting
Omaha
University of Nebraska Medical Center
Recruiting
Omaha
New Hampshire
New Hampshire Oncology Hematology PA-Concord
Recruiting
Concord
Wentworth-Douglass Hospital
Active, not recruiting
Dover
Dartmouth Hitchcock Medical Center
Recruiting
Lebanon
Elliot Hospital
Active, not recruiting
Manchester
Solinsky Center for Cancer Care
Recruiting
Manchester
New Jersey
Hackensack University Medical Center
Recruiting
Hackensack
Holy Name Hospital
Recruiting
Teaneck
Nevada
Comprehensive Cancer Centers of Nevada - Henderson
Recruiting
Henderson
Comprehensive Cancer Centers of Nevada
Recruiting
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Recruiting
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Recruiting
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
Recruiting
Las Vegas
Radiation Oncology Centers of Nevada Central
Recruiting
Las Vegas
New York
Albany Medical Center
Recruiting
Albany
James J Peters VA Medical Center
Recruiting
Bronx
Montefiore Medical Center - Moses Campus
Recruiting
Bronx
Montefiore Medical Center-Einstein Campus
Recruiting
Bronx
Roswell Park Cancer Institute
Recruiting
Buffalo
Noyes Memorial Hospital/Myers Cancer Center
Recruiting
Dansville
Glens Falls Hospital
Recruiting
Glens Falls
Northwell Health/Center for Advanced Medicine
Recruiting
Lake Success
NYP/Weill Cornell Medical Center
Suspended
New York
Upstate Cancer Center Radiation Oncology at Oneida
Recruiting
Oneida
Upstate Cancer Center Radiation Oncology at Oswego
Recruiting
Oswego
Highland Hospital
Recruiting
Rochester
University of Rochester
Recruiting
Rochester
Stony Brook University Medical Center
Recruiting
Stony Brook
State University of New York Upstate Medical University
Recruiting
Syracuse
Ohio
Cleveland Clinic Mercy Hospital
Recruiting
Canton
Miami Valley Hospital South
Recruiting
Centerville
University of Cincinnati Cancer Center-UC Medical Center
Recruiting
Cincinnati
MetroHealth Medical Center
Recruiting
Cleveland
Ohio State University Comprehensive Cancer Center
Recruiting
Columbus
Miami Valley Hospital North
Recruiting
Dayton
Greater Dayton Cancer Center
Recruiting
Kettering
Kettering Medical Center
Recruiting
Kettering
ProMedica Flower Hospital
Recruiting
Sylvania
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Recruiting
Toledo
University of Toledo
Recruiting
Toledo
University of Cincinnati Cancer Center-West Chester
Recruiting
West Chester
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Oregon
Legacy Mount Hood Medical Center
Active, not recruiting
Gresham
Legacy Good Samaritan Hospital and Medical Center
Active, not recruiting
Portland
Oregon Health and Science University
Active, not recruiting
Portland
Pennsylvania
Geisinger Medical Center
Recruiting
Danville
Ephrata Cancer Center
Recruiting
Ephrata
Adams Cancer Center
Recruiting
Gettysburg
Sechler Family Cancer Center
Recruiting
Lebanon
Geisinger Medical Oncology-Lewisburg
Recruiting
Lewisburg
Temple University Hospital
Withdrawn
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
Recruiting
Pittsburgh
UPMC-Shadyside Hospital
Recruiting
Pittsburgh
Geisinger Wyoming Valley/Henry Cancer Center
Recruiting
Wilkes-barre
WellSpan Health-York Cancer Center
Recruiting
York
South Carolina
Prisma Health Cancer Institute - Spartanburg
Recruiting
Boiling Springs
Medical University of South Carolina
Recruiting
Charleston
Prisma Health Cancer Institute - Eastside
Recruiting
Greenville
Prisma Health Cancer Institute - Faris
Recruiting
Greenville
Saint Francis Cancer Center
Recruiting
Greenville
Prisma Health Cancer Institute - Greer
Recruiting
Greer
Carolina Regional Cancer Center
Recruiting
Myrtle Beach
Levine Cancer Institute-Rock Hill
Recruiting
Rock Hill
Rock Hill Radiation Therapy Center
Recruiting
Rock Hill
Prisma Health Cancer Institute - Seneca
Recruiting
Seneca
Tennessee
Vanderbilt University/Ingram Cancer Center
Recruiting
Nashville
Texas
MD Anderson in The Woodlands
Recruiting
Conroe
Parkland Memorial Hospital
Recruiting
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Recruiting
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
Recruiting
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Recruiting
Houston
Ben Taub General Hospital
Recruiting
Houston
Houston Methodist Hospital
Active, not recruiting
Houston
Lyndon Baines Johnson General Hospital
Recruiting
Houston
M D Anderson Cancer Center
Recruiting
Houston
MD Anderson West Houston
Recruiting
Houston
Michael E DeBakey VA Medical Center
Recruiting
Houston
MD Anderson League City
Recruiting
League City
UT Southwestern Clinical Center at Richardson/Plano
Recruiting
Richardson
Audie L Murphy VA Hospital
Recruiting
San Antonio
University of Texas Health Science Center at San Antonio
Recruiting
San Antonio
MD Anderson in Sugar Land
Recruiting
Sugar Land
Scott and White Memorial Hospital
Active, not recruiting
Temple
Utah
American Fork Hospital / Huntsman Intermountain Cancer Center
Suspended
American Fork
Sandra L Maxwell Cancer Center
Suspended
Cedar City
Logan Regional Hospital
Suspended
Logan
Intermountain Medical Center
Suspended
Murray
McKay-Dee Hospital Center
Suspended
Ogden
Utah Valley Regional Medical Center
Suspended
Provo
Riverton Hospital
Suspended
Riverton
Saint George Regional Medical Center
Suspended
Saint George
George E Wahlen Department of Veterans Affairs Medical Center
Recruiting
Salt Lake City
Huntsman Cancer Institute/University of Utah
Recruiting
Salt Lake City
LDS Hospital
Suspended
Salt Lake City
University of Utah Sugarhouse Health Center
Recruiting
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Suspended
Salt Lake City
Virginia
Bon Secours Saint Francis Medical Center
Recruiting
Midlothian
Bon Secours Cancer Institute at Reynolds Crossing
Recruiting
Richmond
VCU Massey Cancer Center at Stony Point
Recruiting
Richmond
Virginia Commonwealth University/Massey Cancer Center
Recruiting
Richmond
VCU Community Memorial Health Center
Recruiting
South Hill
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Recruiting
Berlin
University of Vermont Medical Center
Recruiting
Burlington
Washington
FHCC Overlake
Recruiting
Bellevue
Seattle Cancer Care Alliance at EvergreenHealth
Recruiting
Kirkland
FHCC at Northwest Hospital
Recruiting
Seattle
FHCC South Lake Union
Recruiting
Seattle
University of Washington Medical Center - Montlake
Recruiting
Seattle
Legacy Salmon Creek Hospital
Active, not recruiting
Vancouver
Wisconsin
Langlade Hospital and Cancer Center
Recruiting
Antigo
Marshfield Medical Center-EC Cancer Center
Recruiting
Eau Claire
Mayo Clinic Health System-Franciscan Healthcare
Active, not recruiting
La Crosse
Marshfield Medical Center-Marshfield
Recruiting
Marshfield
Froedtert Menomonee Falls Hospital
Recruiting
Menomonee Falls
Medical College of Wisconsin
Recruiting
Milwaukee
Zablocki Veterans Administration Medical Center
Recruiting
Milwaukee
Marshfield Clinic-Minocqua Center
Recruiting
Minocqua
Cancer Center of Western Wisconsin
Recruiting
New Richmond
Drexel Town Square Health Center
Recruiting
Oak Creek
Marshfield Medical Center-Rice Lake
Recruiting
Rice Lake
Marshfield Medical Center-River Region at Stevens Point
Recruiting
Stevens Point
Aspirus Regional Cancer Center
Recruiting
Wausau
Froedtert West Bend Hospital/Kraemer Cancer Center
Recruiting
West Bend
Diagnostic and Treatment Center
Recruiting
Weston
Marshfield Medical Center - Weston
Recruiting
Weston
Aspirus Cancer Care - Wisconsin Rapids
Recruiting
Wisconsin Rapids
West Virginia
West Virginia University Healthcare
Recruiting
Morgantown
Other Locations
Mexico
Instituto Nacional De Cancerologia de Mexico
Recruiting
Mexico City
Contact Information
Primary
Dana Sparks, MAT
dsparks@swog.org
2106148808
Time Frame
Start Date: September 17, 2018
Estimated Completion Date: October 1, 2031
Participants
Target number of participants: 1273
Treatments
Active Comparator: Arm I (SST)
Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.
Experimental: Arm II (SST, prostatectomy or radiation therapy)
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.
Active Comparator: Step 1 (pre-randomization)
Standard treatment data collection prior to randomization
Authors
William T. Lowrance, Katie S. Murray, Sinisa Stanic, David T. Marshall, Firas G. Petros, Scott Cheney, Douglas Scherr, Michael J. Whalen, Siamak Daneshmand, Aditya Bagrodia, Ralph J. Hauke, Thomas H. Openshaw, Scott E. Delacroix, Samuel D. Kaffenberger, Gennady Bratslavsky, Juan Chipollini, Ahmed A. Aboumohamed, Richard K. Valicenti, Bryan A. Faller, Anthony P. Gulati, Supriya Jain, Shreya Sinha, Evan Kovac, Jeffrey Sparenborg, Bruce J. Averbook, Howard M. Gross, Jay W. Carlson, William J. Irvin, Sarah B. Carroll, Yousef Zakharia, Amir Lavaf, Arul Mahadevan, Gurkamal S. Chatta, Martha P. Mims, Michael A. Schwartz, Danh C. Pham, Glen W. McWilliams, James E. Radford, Sarah J. Sinclair, Jeffrey K. Giguere, Alvaro Pereira-Rico, Paul M. Barr, Brian C. Baumann, John M. Schallenkamp, Chinedu Mmeje, Ding Wang, Wayne B. Harris, Gregory A. Masters, Jonathan J. Melquist, Rashmi Verma, Frank A. Vicini, John C. Henegan, Kerry R. Schaffer, Jennifer Vogel, Michael A. Liss, Suzanne M. Cole, Patricia H. Hardenbergh, Abhinav Sidana, Matthew H. Hayn, Shreyas Joshi, Elizabeth Henry, Joshua Lukenbill, Marwan Massouh, Elisabeth I. Heath, Lynn J. Howie, Ross E. Krasnow, Benjamin J. Davies, Asit K. Paul, Tanya B. Dorff, Russell Z. Szmulewitz, Nicholas DiBella, Ki Y. Chung, Elizabeth M. Gore, Ami Badami, Nikhil V. Kamat, Debra M. Prow, Anuradha Kunthur, Jason Comer, Kelly L. Stratton, Seth O. Fagbemi, Jeffrey A. Forquer, Kirk A. Keegan, Rodwell Mabaera, Manish A. Vira, Tarek M. Sabagh, Geoffrey A. Sonn, Greg Gin, Haythem Y. Ali, Brian Chapin, Srinivas Vourganti, Paul D. Maroni, Nabil Adra, Douglas J. Weckstein, Badar M. Mian, John K. Parsons, Daniel Landau, Samantha A. Seaward, Eric W. Dean, Praveen Vashist, Rohan Garje, Saira Hassan, Michael A. Gorin, Uzair B. Chaudhary, Albert Attia, Benjamin T. Marchello, Preston C. Sprenkle, Steven K. Clinton, Tomasz M. Beer, Amir Kamran, Elan S. Diamond, Brendan Connell, Benjamin A. Teply, Sumati V. Gupta, Nataniel H. Lester-Coll, Daniel Moreira, Troy A. Fiddler, Scott R. Silva, Ulka N. Vaishampayan, Richard L. Deming, Daniel W. Lin, Aihua E. Yen, Andrea L. Harzstark, David M. King, Christopher S. Platta, Massimiliano Spaliviero, Alejandro Sanchez, William Parker, Rana R. McKay, Mitchell Haut, Miguel A. Jimenez-Rios, Amit B. Shah, Shi-Ming Tu, Earle F. Burgess, Sharad A. Ghamande, David VanderWeele, Christopher H. Chay, Mehrdad Alemozaffar, Kathleen J. Yost, Chad R. Ritch, John A. Ellerton, Brian J. Miles, Jason C. Lee, Jacqueline Vuky, Scott Johnson, Christopher M. Reynolds, Robert S. Alter, William Tse
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: Southwest Oncology Group

This content was sourced from clinicaltrials.gov

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