What type of study is this?

This is a Pre-Registered Trial study.

February 26, 2026

Steroidogenesis inhibitor opevesostat (MK-5684) for metastatic castration-resistant prostate cancer: OMAHA-003 and OMAHA-004 trial designs.

Key Points

To evaluate the efficacy and safety of opevesostat, a steroidogenesis inhibitor, for mCRPC patients.
Randomized phase III trials OMAHA-003 and OMAHA-004 are designed to compare opevesostat to androgen receptor pathway inhibitor switch.
Participants include patients with previously treated mCRPC.
The trials will assess efficacy and safety outcomes.
The results will determine if opevesostat is a viable treatment option for metastatic castration-resistant prostate cancer.
The expected outcomes could identify new approaches to overcome resistance in mCRPC.

Abstract

Treatment options for metastatic castration-resistant prostate cancer (mCRPC) include androgen receptor pathway inhibitors (ARPIs), taxanes, radium-223, Lu-PSMA, poly (ADP-ribose) polymerase inhibitors, and immunotherapy in select patients. Resistance to ARPIs and hormone-based therapies has been associated with AR-ligand-binding domain mutations that can lead to promiscuous stimulation by other steroid hormones. There is a need to explore alternative targets and develop next-generation ARPIs or combination therapies that overcome this resistance. We describe the rationale and design of the randomized phase III trials OMAHA-003 (NCT06136624) and OMAHA-004 (NCT06136650), which will evaluate the efficacy and safety of opevesostat, a steroidogenesis inhibitor, versus ARPI switch in previously treated mCRPC. Results may support opevesostat as a potential new treatment option for mCRPC.Clinical trial registration: www.clinicaltrials.gov identifiers are NCT06136624 and NCT06136650.

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