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 now · Phase 3

Conditions studied: Metastatic Castration-resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06764485

Run by

Celgene

People needed

960

Starts

2025-03-13

Expected to finish

2029-01-19

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

• Perlmutter Cancer Center at NYU Langone Hospital - Long Island — Mineola, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• Central Alabama Research — Birmingham, Alabama, United States (enrolling)
• Laura and Isaac Perlmutter Cancer Center — New York, New York, United States (enrolling)
• San Francisco VA Health Care System — San Francisco, California, United States (enrolling)
• Moores Cancer Center — La Jolla, California, United States (enrolling)
• Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States (enrolling)
• New Mexico Oncology Hematology Consultants Ltd. — Albuquerque, New Mexico, United States (enrolling)
• Colorado Clinical Research — Lakewood, Colorado, United States (enrolling)
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Lakeland Regional Cancer Center — Lakeland, Florida, United States (enrolling)
• California Pacific Medical Center — San Francisco, California, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• The University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States (enrolling)
• Wichita Urology Group — Wichita, Kansas, United States (enrolling)
• Chesapeake Urology — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• James M Stockman Cancer Institute — Frederick, Maryland, United States (enrolling)
• Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States (enrolling)
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (enrolling)
• Thomas Jefferson University, Kennedy Health Alliance — Sewell, New Jersey, United States (enrolling)
• University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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