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


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

Intervention:

  • Drug: Abiraterone
  • Drug: Bicalutamide
  • Drug: Degarelix
  • Drug: Docetaxel
  • Drug: Flutamide
  • Drug: Goserelin Acetate
  • Drug: Histrelin Acetate
  • Drug: Leuprolide Acetate
  • Drug: Nilutamide
  • Procedure: Orchiectomy
  • Drug: Prednisone
  • Other: Quality-of-Life Assessment
  • Radiation: Radiation Therapy
  • Procedure: Radical Prostatectomy
  • Drug: Triptorelin

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03678025

Sponsor: Southwest Oncology Group

Primary Outcome Measures:

  • Measure: Overall survival (OS)
  • Time Frame: From date of randomization to date of death due to any cause, assessed up to 8 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Media OS
  • Time Frame: From date of randomization to date of death due to any cause, assessed up to 8 years
  • Safety Issue:
  • Measure: Rate of symptomatic local progression
  • Time Frame: Up to 8 years
  • Safety Issue:
  • Measure: Progression-free survival (PFS)
  • Time Frame: From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 8 years
  • Safety Issue:

Estimated Enrollment: 1273

Study Start Date: September 17, 2018

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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.

Contact:

  • Dana Sparks, MAT
  • 2106148808 Ext. 1004

Locations:

  • Mayo Clinic Hospital
  • Phoenix Arizona 85054 United States
  • University of Arizona Cancer Center-Orange Grove Campus
  • Tucson Arizona 85704 United States
  • University of Arizona Cancer Center-North Campus
  • Tucson Arizona 85719 United States
  • University of Arkansas for Medical Sciences
  • Little Rock Arkansas 72205 United States
  • City of Hope Comprehensive Cancer Center
  • Duarte California 91010 United States
  • UC San Diego Moores Cancer Center
  • La Jolla California 92093 United States
  • Los Angeles County-USC Medical Center
  • Los Angeles California 90033 United States
  • USC / Norris Comprehensive Cancer Center
  • Los Angeles California 90033 United States
  • Fremont - Rideout Cancer Center
  • Marysville California 95901 United States
  • Kaiser Permanente Oakland-Broadway
  • Oakland California 94611 United States
  • Kaiser Permanente-Rancho Cordova Cancer Center
  • Rancho Cordova California 95670 United States
  • Rohnert Park Cancer Center
  • Rohnert Park California 94928 United States
  • The Permanente Medical Group-Roseville Radiation Oncology
  • Roseville California 95678 United States
  • University of California Davis Comprehensive Cancer Center
  • Sacramento California 95817 United States
  • South Sacramento Cancer Center
  • Sacramento California 95823 United States
  • Kaiser Permanente Medical Center - Santa Clara
  • Santa Clara California 95051 United States
  • Kaiser Permanente Cancer Treatment Center
  • South San Francisco California 94080 United States
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
  • Truckee California 96161 United States
  • University of Colorado Hospital
  • Aurora Colorado 80045 United States
  • UCHealth Memorial Hospital Central
  • Colorado Springs Colorado 80909 United States
  • Memorial Hospital North
  • Colorado Springs Colorado 80920 United States
  • Poudre Valley Hospital
  • Fort Collins Colorado 80524 United States
  • Yale University
  • New Haven Connecticut 06520 United States
  • Helen F Graham Cancer Center
  • Newark Delaware 19713 United States
  • Christiana Care Health System-Christiana Hospital
  • Newark Delaware 19718 United States
  • MedStar Washington Hospital Center
  • Washington District of Columbia 20010 United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Miami Florida 33136 United States
  • UF Cancer Center at Orlando Health
  • Orlando Florida 32806 United States
  • Emory University Hospital/Winship Cancer Institute
  • Atlanta Georgia 30322 United States
  • Emory Saint Joseph's Hospital
  • Atlanta Georgia 30342 United States
  • Saint Alphonsus Cancer Care Center-Caldwell
  • Caldwell Idaho 83605 United States
  • Rush - Copley Medical Center
  • Aurora Illinois 60504 United States
  • Rush University Medical Center
  • Chicago Illinois 60612 United States
  • University of Illinois
  • Chicago Illinois 60612 United States
  • University of Chicago Comprehensive Cancer Center
  • Chicago Illinois 60637 United States
  • Decatur Memorial Hospital
  • Decatur Illinois 62526 United States
  • Crossroads Cancer Center
  • Effingham Illinois 62401 United States
  • Methodist Medical Center of Illinois
  • Peoria Illinois 61636 United States
  • OSF Saint Francis Medical Center
  • Peoria Illinois 61637 United States
  • Southwest Illinois Health Services LLP
  • Swansea Illinois 62226 United States
  • Carle Cancer Center
  • Urbana Illinois 61801 United States
  • Indiana University/Melvin and Bren Simon Cancer Center
  • Indianapolis Indiana 46202 United States
  • McFarland Clinic PC - Ames
  • Ames Iowa 50010 United States
  • University of Kansas Cancer Center
  • Kansas City Kansas 66160 United States
  • University of Kansas Cancer Center-Overland Park
  • Overland Park Kansas 66210 United States
  • University of Kansas Hospital-Westwood Cancer Center
  • Westwood Kansas 66205 United States
  • The James Graham Brown Cancer Center at University of Louisville
  • Louisville Kentucky 40202 United States
  • East Jefferson General Hospital
  • Metairie Louisiana 70006 United States
  • LSU Healthcare Network / Metairie Multi-Specialty Clinic
  • Metairie Louisiana 70006 United States
  • Lafayette Family Cancer Center-EMMC
  • Brewer Maine 04412 United States
  • Maine Medical Center-Bramhall Campus
  • Portland Maine 04102 United States
  • Maine Medical Center- Scarborough Campus
  • Scarborough Maine 04074 United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Baltimore Maryland 21287 United States
  • Lahey Hospital and Medical Center
  • Burlington Massachusetts 01805 United States
  • Saint Joseph Mercy Hospital
  • Ann Arbor Michigan 48106 United States
  • University of Michigan Comprehensive Cancer Center
  • Ann Arbor Michigan 48109 United States
  • Saint Joseph Mercy Brighton
  • Brighton Michigan 48114 United States
  • Henry Ford Cancer Institute-Downriver
  • Brownstown Michigan 48183 United States
  • Saint Joseph Mercy Canton
  • Canton Michigan 48188 United States
  • Saint Joseph Mercy Chelsea
  • Chelsea Michigan 48118 United States
  • Henry Ford Macomb Hospital-Clinton Township
  • Clinton Township Michigan 48038 United States
  • Wayne State University/Karmanos Cancer Institute
  • Detroit Michigan 48201 United States
  • Henry Ford Hospital
  • Detroit Michigan 48202 United States
  • Henry Ford West Bloomfield Hospital
  • West Bloomfield Michigan 48322 United States
  • Hennepin County Medical Center
  • Minneapolis Minnesota 55415 United States
  • Health Partners Inc
  • Minneapolis Minnesota 55454 United States
  • Mayo Clinic
  • Rochester Minnesota 55905 United States
  • Regions Hospital
  • Saint Paul Minnesota 55101 United States
  • Saint Francis Regional Medical Center
  • Shakopee Minnesota 55379 United States
  • University of Mississippi Medical Center
  • Jackson Mississippi 39216 United States
  • Saint Francis Medical Center
  • Cape Girardeau Missouri 63703 United States
  • Southeast Cancer Center
  • Cape Girardeau Missouri 63703 United States
  • Siteman Cancer Center at West County Hospital
  • Creve Coeur Missouri 63141 United States
  • The University of Kansas Cancer Center-North
  • Kansas City Missouri 64154 United States
  • Washington University School of Medicine
  • Saint Louis Missouri 63110 United States
  • Siteman Cancer Center-South County
  • Saint Louis Missouri 63129 United States
  • Missouri Baptist Medical Center
  • Saint Louis Missouri 63131 United States
  • Siteman Cancer Center at Saint Peters Hospital
  • Saint Peters Missouri 63376 United States
  • Benefis Healthcare- Sletten Cancer Institute
  • Great Falls Montana 59405 United States
  • Kalispell Regional Medical Center
  • Kalispell Montana 59901 United States
  • Nebraska Methodist Hospital
  • Omaha Nebraska 68114 United States
  • University of Nebraska Medical Center
  • Omaha Nebraska 68198 United States
  • Comprehensive Cancer Centers of Nevada - Henderson
  • Henderson Nevada 89052 United States
  • Comprehensive Cancer Centers of Nevada - Northwest
  • Las Vegas Nevada 89128 United States
  • Comprehensive Cancer Centers of Nevada-Summerlin
  • Las Vegas Nevada 89144 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89148 United States
  • Comprehensive Cancer Centers of Nevada - Central Valley
  • Las Vegas Nevada 89169 United States
  • New Hampshire Oncology Hematology PA-Concord
  • Concord New Hampshire 03301 United States
  • New Hampshire Oncology Hematology PA-Hooksett
  • Hooksett New Hampshire 03106 United States
  • Roswell Park Cancer Institute
  • Buffalo New York 14263 United States
  • NYP/Weill Cornell Medical Center
  • New York New York 10065 United States
  • University of Rochester
  • Rochester New York 14642 United States
  • Stony Brook University Medical Center
  • Stony Brook New York 11794 United States
  • State University of New York Upstate Medical University
  • Syracuse New York 13210 United States
  • Mission Hospital Inc-Memorial Campus
  • Asheville North Carolina 28801 United States
  • CarolinaEast Medical Center
  • New Bern North Carolina 28561 United States
  • Mercy Medical Center
  • Canton Ohio 44708 United States
  • University of Cincinnati/Barrett Cancer Center
  • Cincinnati Ohio 45219 United States
  • Ohio State University Comprehensive Cancer Center
  • Columbus Ohio 43210 United States
  • Kettering Medical Center
  • Kettering Ohio 45429 United States
  • University of Oklahoma Health Sciences Center
  • Oklahoma City Oklahoma 73104 United States
  • Legacy Mount Hood Medical Center
  • Gresham Oregon 97030 United States
  • Legacy Good Samaritan Hospital and Medical Center
  • Portland Oregon 97210 United States
  • Oregon Health and Science University
  • Portland Oregon 97239 United States
  • University of Pittsburgh Cancer Institute (UPCI)
  • Pittsburgh Pennsylvania 15232 United States
  • UPMC-Shadyside Hospital
  • Pittsburgh Pennsylvania 15232 United States
  • Medical University of South Carolina
  • Charleston South Carolina 29425 United States
  • Greenville Health System Cancer Institute-Faris
  • Greenville South Carolina 29605 United States
  • Greenville Health System Cancer Institute-Eastside
  • Greenville South Carolina 29615 United States
  • Greenville Health System Cancer Institute-Greer
  • Greer South Carolina 29650 United States
  • Greenville Health System Cancer Institute-Seneca
  • Seneca South Carolina 29672 United States
  • Greenville Health System Cancer Institute-Spartanburg
  • Spartanburg South Carolina 29307 United States
  • Vanderbilt University/Ingram Cancer Center
  • Nashville Tennessee 37232 United States
  • Lyndon Baines Johnson General Hospital
  • Houston Texas 77026-1967 United States
  • Ben Taub General Hospital
  • Houston Texas 77030 United States
  • M D Anderson Cancer Center
  • Houston Texas 77030 United States
  • American Fork Hospital / Huntsman Intermountain Cancer Center
  • American Fork Utah 84003 United States
  • Sandra L Maxwell Cancer Center
  • Cedar City Utah 84720 United States
  • Logan Regional Hospital
  • Logan Utah 84321 United States
  • Intermountain Medical Center
  • Murray Utah 84107 United States
  • McKay-Dee Hospital Center
  • Ogden Utah 84403 United States
  • Utah Valley Regional Medical Center
  • Provo Utah 84604 United States
  • Riverton Hospital
  • Riverton Utah 84065 United States
  • Dixie Medical Center Regional Cancer Center
  • Saint George Utah 84770 United States
  • Utah Cancer Specialists-Salt Lake City
  • Salt Lake City Utah 84106 United States
  • Huntsman Cancer Institute/University of Utah
  • Salt Lake City Utah 84112 United States
  • LDS Hospital
  • Salt Lake City Utah 84143 United States
  • Virginia Commonwealth University/Massey Cancer Center
  • Richmond Virginia 23298 United States
  • University of Washington Medical Center
  • Seattle Washington 98195 United States
  • Legacy Salmon Creek Hospital
  • Vancouver Washington 98686 United States
  • Marshfield Medical Center-EC Cancer Center
  • Eau Claire Wisconsin 54701 United States
  • Mayo Clinic Health System-Franciscan Healthcare
  • La Crosse Wisconsin 54601 United States
  • Marshfield Medical Center-Marshfield
  • Marshfield Wisconsin 54449 United States
  • Community Memorial Hospital
  • Menomonee Falls Wisconsin 53051 United States
  • Froedtert and the Medical College of Wisconsin
  • Milwaukee Wisconsin 53226 United States
  • Marshfield Clinic-Minocqua Center
  • Minocqua Wisconsin 54548 United States
  • Marshfield Medical Center-Rice Lake
  • Rice Lake Wisconsin 54868 United States
  • Marshfield Clinic Stevens Point Center
  • Stevens Point Wisconsin 54482 United States
  • The Alyce and Elmore Kraemer Cancer Care Center
  • West Bend Wisconsin 53095 United States
  • Diagnostic and Treatment Center
  • Weston Wisconsin 54476 United States

View trial on ClinicalTrials.gov


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