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
Study Phase: Phase 3
Recruitment Status: Recruiting
Start Date: March 13, 2025
End Date: January 19, 2029
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.
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.
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Conditions:
- Prostatic Neoplasms