A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
NCT06136650Phase 3Recruiting
- Lead sponsor
- Merck Sharp & Dohme LLC (Industry)
- Enrollment
- 1,314 (estimated)
- Start date
- 18 Dec 2023
- Primary completion
- 10 May 2028 (estimated)
- Study completion
- 2 Dec 2030
- Last update posted
- 20 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 2
Interventions
- Opevesostat Drug
- Dexamethasone Drug
- Fludrocortisone acetate Drug
- Hydrocortisone Drug
- Abiraterone acetate Drug
- Prednisone acetate Drug
- Enzalutamide Drug
Conditions and primary outcome
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Prostatic Neoplasms
Primary outcome
Overall Survival (OS) (Up to approximately 82 months)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedSteroidogenesis inhibitor opevesostat (MK-5684) for metastatic castration-resistant prostate cancer: OMAHA-003 and OMAHA-004 trial designs.
Future oncology (London, England) · 2026 Mar
PubMed 41732008 (opens in a new tab)DOI 10.1080/14796694.2025.2595914 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT06136650 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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