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 (rechARge)

NCT 06764485

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.

Intervention / Treatment 

  • Drug: BMS-986365
  • Drug: Enzalutamide
  • Drug: Abiraterone
  • Drug: Docetaxel
  • Drug: Predinsone/Prednisolone

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).

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