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Clinical Trials in the USA / NCT06764485
Active, not recruiting Phase 3

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

NCT06764485 · tracked via the Priya Life Science USA tracker
Sponsor
Celgene
Phase
Phase 3
Started
2025-03-13
Last updated
2026-09-08

Condition(s) studied

Metastatic Castration-resistant Prostate Cancer

Investigational drug(s) / intervention(s)

BMS-986365EnzalutamideAbirateroneDocetaxelPredinsone/Prednisolone

BMS-986365: Specified dose on specified days

Enzalutamide: Specified dose on specified days

Abiraterone: Specified dose on specified days

Docetaxel: Specified dose on specified days

Predinsone/Prednisolone: Specified dose on specified days

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (212)

FacilityCityRegionStatus
Local Institution - 0330 Birmingham Alabama
Local Institution - 0329 Gilbert Arizona
Local Institution - 0370 Anaheim California
Local Institution - 0015 La Jolla California
Local Institution - 0224 Los Alamitos California
Local Institution - 0016 San Francisco California
Local Institution - 0411 San Francisco California
Local Institution - 0238 Aurora Colorado
Local Institution - 0294 Denver Colorado
Local Institution - 0419 Lakewood Colorado
Local Institution - 0413 Washington D.C. District of Columbia
Local Institution - 0426 Lakeland Florida
Local Institution - 0077 Athens Georgia
Local Institution - 0048 Chicago Illinois
Local Institution - 0331 Westwood Kansas
Local Institution - 0060 Wichita Kansas
Local Institution - 0054 Baltimore Maryland
Local Institution - 0019 Baltimore Maryland
Local Institution - 0344 Frederick Maryland
Local Institution - 0429 Sewell New Jersey
Local Institution - 0081 Albuquerque New Mexico
Local Institution - 0334 Albuquerque New Mexico
Local Institution - 0197 Buffalo New York
Local Institution - 0412 Mineola New York
Local Institution - 0069 New York New York
Local Institution - 0076 New York New York
Local Institution - 0085 New York New York
Local Institution - 0071 New York New York
Local Institution - 0225 Syracuse New York
Local Institution - 0056 Columbus Ohio
Local Institution - 0067 Portland Oregon
Local Institution - 0416 Portland Oregon
Local Institution - 0345 Philadelphia Pennsylvania
Local Institution - 0414 Philadelphia Pennsylvania
Local Institution - 0057 Philadelphia Pennsylvania
Local Institution - 0349 Willow Grove Pennsylvania
Local Institution - 0055 Charleston South Carolina
Local Institution - 0079 Myrtle Beach South Carolina
Local Institution - 0335 Nashville Tennessee
Local Institution - 0018 Austin Texas

+ 172 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06764485 on ClinicalTrials.gov ↗ ← All trials in the USA