Study Comparing BMS-986365 with Other Treatments for Advanced Prostate Cancer
Sponsor: Celgene
ClinicalTrials ID:NCT06764485
This clinical trial is testing a new drug, BMS-986365, to see how well it works and how safe it is compared to other standard treatments for men with advanced prostate cancer that no longer responds to hormone therapy.
Patient Parameters
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Program Overview
The study aims to find out if BMS-986365 is more effective and safer than other treatments chosen by doctors for men with metastatic castration-resistant prostate cancer, which is a type of prostate cancer that has spread and is not responding to hormone therapy.
Description
The main goal of this study is to compare how long patients live without their cancer getting worse when taking BMS-986365 versus other standard treatments. These standard treatments include Docetaxel with Prednisone/Prednisolone, Abiraterone with Prednisone/Prednisolone, or Enzalutamide.
In the first part of the study, participants will be randomly assigned to one of three groups: two different doses of BMS-986365 or a group receiving the standard treatment chosen by their doctor. In the second part, participants will be randomly assigned to either the selected dose of BMS-986365 or the standard treatment group. The study will help determine which treatment option is more effective in controlling the cancer and is safer for patients.
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0330 | 35209 | Birmingham | Alabama |
| Local Institution - 0329 | 85234 | Gilbert | Arizona |
| Local Institution - 0015 | 92093 | La Jolla | California |
| Local Institution - 0224 | 90720 | Los Alamitos | California |
| Local Institution - 0370 | 90017 | Los Angeles | California |
| Local Institution - 0364 | 90048 | Los Angeles | California |
| Local Institution - 0016 | 94115 | San Francisco | California |
| Local Institution - 0411 | 94121 | San Francisco | California |
| Local Institution - 0238 | 80045 | Aurora | Colorado |
| Local Institution - 0294 | 80218 | Denver | Colorado |
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