Study of BMS-986365 for Metastatic Castration-Resistant Prostate Cancer

This study is looking into a new drug, BMS-986365, for men with metastatic castration-resistant prostate cancer (prostate cancer that has spread and is no longer responding to hormone therapy). It compares BMS-986365 to standard treatments like enzalutamide, abiraterone, or docetaxel, which may be given with prednisone/prednisolone. The main goal is to see if BMS-986365 can stop the cancer from growing or spreading for longer than current treatments. You might be able to join if you are an adult male with prostate cancer that has spread and has been confirmed by a doctor. The study is currently unclear on its recruitment status and plans to enroll 960 participants.

Study design
This is an interventional study where participants will be randomly assigned to receive either BMS-986365 or one of the standard treatments. In Part 1, participants are assigned to one of two doses of BMS-986365 or a standard treatment, while in Part 2, they are assigned to one selected dose of BMS-986365 or a standard treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 4 years to track how long the cancer is kept from growing or spreading.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06764485

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
PHASE3Ages 18+InterventionalTreatment
Celgene
~960 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:BMS-986365EnzalutamideAbirateroneDocetaxelPredinsone/Prednisolone

At a glance

Recruiting sites
183 of 281 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria
Measured over Up to 4 years
Metastatic Castration-resistant Prostate Cancer
281 sites across 153 states
Germany9
Spain8
California7
New York7
Italy7
Zhejiang6
Turkey (Türkiye)6
Pennsylvania5
  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Eligibility criteria

Inclusion

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

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.
  • Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteriaUp to 4 years