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

ID#: NCT06764485

Age: 18 years - 66+

Gender: Male

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: March 13, 2025

End Date: January 19, 2029

Contact Information:
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
First line of the email MUST contain the NCT# and Site#
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:

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.