A Phase 3 Study of BMS-986365 Versus Standard Therapy in People With Advanced Prostate Cancer

Full Title

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 (WCG)

Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the best treatments for prostate cancers that have metastasized (spread). The benefits of hormone treatments often do not last, however. Over time, many prostate cancers keep growing even with hormonal therapies. These are called castration-resistant prostate cancers (CRPC).

Researchers are comparing two different doses of BMS-986365 to standard therapy in people with CRPC.  If you join this study, you will be randomly assigned to get BMS-986365 or one of these treatments (as decided by you and your treating physician):

  • Abiraterone plus prednisone/prednisolone
  • Docetaxel plus prednisone/prednisolone
  • Enzalutamide

Who Can Join

To join this study, there are a few conditions. You must:

  • Have CRPC that keeps growing after prior treatment that included abiraterone, enzalutamide, apalutamide, or darolutamide.
  • Have recovered from the serious side effects of previous therapies before getting the study treatment.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Dana Rathkopf’s office at 646-422-4379.

Protocol

25-153

Phase

Phase III (phase 3)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06764485