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Be Part of Research - Trial Details - Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Recruiting

Open to: ALL

Age: All

Medical Conditions

Prostate Cancer Metastatic


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2023 Aug 2028

Publications

"Yu EY, Gratzke C, Burotto M, Zhang AY, Levesque E, Ortega F, Peer A, Vile D, Chen ZH, Song Y, Schloss C, Todoric J, Garratt C, Poehlein C, Antonarakis ES, Fizazi K. Steroidogenesis inhibitor opevesostat (MK-5684) for metastatic castration-resistant prostate cancer: OMAHA-003 and OMAHA-004 trial designs. Future Oncol. 2026 Mar;22(7):765-772. doi: 10.1080/14796694.2025.2595914. Epub 2026 Feb 23."; "41732008"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : Opevesostat;

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : Abiraterone Acetate or Enzalutamide;

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : Abiraterone Acetate or Enzalutamide;

Intervention Type : DRUG
Intervention Description : Administered orally or IM as a rescue medication

Intervention Arm Group : Opevesostat;

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : Opevesostat;

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : Abiraterone Acetate or Enzalutamide;

Intervention Type : DRUG
Intervention Description : Administered orally as rescue medication

Intervention Arm Group : Opevesostat;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Cornwall Hospital ( Site 1610)
    Truro
    England
    TR1 3LJ
  • The Christie NHS Foundation Trust ( Site 1608)
    Manchester
    m20 4bx
  • Addenbrooke's Hospital ( Site 1605)
    Cambridge
    Cambridgeshire
    CB2 2QQ
  • The Beatson West of Scotland Cancer Centre ( Site 1603)
    Glasgow
    Glasgow City
    G12 0YN
  • Charing Cross Hospital-Oncology Research ( Site 1606)
    London
    Hammersmith and Fulham
    W6 8RF


The study is sponsored by Merck Sharp & Dohme LLC and is in collaboration with Orion Corporation, Orion Pharma.





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Read full details for Trial ID: NCT06136624
Last updated 04 May 2026

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