Status:
RECRUITING
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
Lead Sponsor:
Celgene
Conditions:
Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
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...
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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
March 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 19 2029
Estimated Enrollment :
960 Patients enrolled
Trial Details
Trial ID
NCT06764485
Start Date
March 13 2025
End Date
January 19 2029
Last Update
January 28 2026
Active Locations (279)
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1
Central Alabama Research
Birmingham, Alabama, United States, 35209
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
3
Los Angeles Cancer Network (LACN)
Anaheim, California, United States, 92801
4
Moores Cancer Center
La Jolla, California, United States, 92093