A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer
Recruiting · NCT06764485 · Interventional (participants receive a specific treatment) · Lead sponsor: Celgene
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
- Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).
- Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be \< 4.
- Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).
Exclusion criteria
- Participants must not have impaired cardiac function or clinically significant cardiac disease.
- Participants must not have any brain metastasis.
- Participants must not have any liver metastasis.
- Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Where it is running
60 locations listed across 25 US states.
- Central Alabama Research - Birmingham, Alabama, United States
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- Local Institution - 0370 - Anaheim, California, United States
- Moores Cancer Center - La Jolla, California, United States
- Cancer and Blood Specialty Clinic - Los Alamitos, California, United States
- Local Institution - 0364 - Los Angeles, California, United States
- California Pacific Medical Center - San Francisco, California, United States
- San Francisco VA Health Care System - San Francisco, California, United States
- Local Institution - 0458 - Santa Rosa, California, United States
- Rocky Mountain Regional VA Medical Center - Aurora, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Denver, Colorado, United States
- Colorado Clinical Research - Lakewood, Colorado, United States
- Sibley Memorial Hospital - Washington D.C., District of Columbia, United States
- Lakeland Regional Cancer Center - Lakeland, Florida, United States
- Local Institution - 0077 - Athens, Georgia, United States
- Northwestern Memorial Hospital - Chicago, Illinois, United States
- The University of Kansas Cancer Center - Westwood - Westwood, Kansas, United States
- Wichita Urology Group - Wichita, Kansas, United States
- Chesapeake Urology - Baltimore, Maryland, United States
- Johns Hopkins Hospital - Baltimore, Maryland, United States
- James M Stockman Cancer Institute - Frederick, Maryland, United States
- Local Institution - 0104 - Minneapolis, Minnesota, United States
- Local Institution - 0049 - Las Vegas, Nevada, United States
- Thomas Jefferson University, Kennedy Health Alliance - Sewell, New Jersey, United States
- University of New Mexico Comprehensive Cancer Center - Albuquerque, New Mexico, United States
- New Mexico Oncology Hematology Consultants Ltd. - Albuquerque, New Mexico, United States
- Roswell Park Cancer Institute - Buffalo, New York, United States
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island - Mineola, New York, United States
- Laura and Isaac Perlmutter Cancer Center - New York, New York, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Local Institution - 0085 - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Associated Medical Professionals - Urology - Syracuse, New York, United States
- Local Institution - 0056 - Columbus, Ohio, United States
- Providence Portland Medical Center - Portland, Oregon, United States
- Providence St. Vincent Medical Center - Portland, Oregon, United States
- Local Institution - 0433 - Allentown, Pennsylvania, United States
- Philadelphia Veterans Affairs Medical Center - Philadelphia, Pennsylvania, United States
- Thomas Jefferson University - Clinical Research Institute - Philadelphia, Pennsylvania, United States
- Fox Chase Cancer Center - Philadelphia, Pennsylvania, United States
- Asplundh Cancer Pavilion - Willow Grove, Pennsylvania, United States
- Hollings Cancer Center - Charleston, South Carolina, United States
- Carolina Urologic Research Center, LLC - Myrtle Beach, South Carolina, United States
- Tennessee Oncology - Nashville, Tennessee, United States
- Texas Oncology - Central/South Texas - Austin, Texas, United States
- Urology Austin, PLLC - Austin, Texas, United States
- Local Institution - 0220 - Houston, Texas, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Intermountain Medical Center - Murray, Utah, United States
- University of Virginia Cancer Center - Charlottesville, Virginia, United States
- Local Institution - 0023 - Richmond, Virginia, United States
- Local Institution - 0078 - Seattle, Washington, United States
- Northwest Cancer Specialists, P.C. - Vancouver, Washington, United States
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- Local Institution - 0340 - Adana, Turkey (Türkiye)
- Local Institution - 0339 - Ankara, Turkey (Türkiye)
- Local Institution - 0338 - Ankara, Turkey (Türkiye)
- Local Institution - 0341 - Ankara, Turkey (Türkiye)
- Azienda USL 8 di Arezzo - Arezzo, Italy
- Local Institution - 0320 - Badajoz, Spain
Showing 60 of 281 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →