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
Prostate Cancer
Unknown Primary
18 Years and older, Male and Female
CA071-1000 (primary)
NCI-2025-02219
2024-517422-25
U1111-1311-0532
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.
Objectives
The primary objective of this clinical trial is to assess the radiographic progression
free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel +
Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide.
In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose
levels, or to the active comparator arm (investigator's choice). In Part 2 of the study,
participants will be randomized 1:1 between BMS-986365 selected dose, or to the active
comparator arm (investigator's choice).
Eligibility
- 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).
Treatment Sites in Georgia
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