Home › Trials › NCT06764485

Comparing BMS-986365 with standard therapies for advanced prostate cancer

A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

Phase 3 Interventional Celgene · NCT06764485

This study is testing a new drug called BMS-986365 to see if it works better than standard treatments for men with advanced prostate cancer that has spread and is resistant to hormone therapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment960 (estimated)
Ages18 Years and up
SexMale
SponsorCelgene Industry-sponsored
Drugs / interventionsPrednisone
Locations282 sites (Birmingham, Alabama and 281 other locations)
Trial IDNCT06764485 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of BMS-986365 compared to the investigator's choice of therapy in patients with metastatic castration-resistant prostate cancer. Participants will be randomly assigned to receive either BMS-986365 at one of two dose levels or standard treatments such as Docetaxel with Prednisone, Abiraterone with Prednisone, or Enzalutamide. The primary endpoint is to assess radiographic progression-free survival (rPFS) between the treatment groups. The study is divided into two parts, with randomization occurring at different stages to ensure robust data collection.

Who should consider this trial

Good fit: Ideal candidates include men with confirmed metastatic castration-resistant prostate cancer who have previously received androgen receptor pathway inhibitors.

Not a fit: Patients with significant cardiac disease, brain or liver metastases, or those with severe symptoms from prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced prostate cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches in targeting advanced prostate cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 281 other locations

+232 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Castration-resistant Prostate CancerProstate cancerProtein degraderProtein degradationAndrogen receptorCastrate resistant prostate cancerCastration resistant prostate cancerHormone resistant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.