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Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
NCT06136624 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Enzalutamide
- DRUG Hydrocortisone
- DRUG Abiraterone acetate
- DRUG Opevesostat
- DRUG Fludrocortisone acetate
Study Locations (20)
Colorado
- Anschutz Cancer Pavilion ( Site 0046) — Aurora
- University of Colorado Health - Highlands Ranch Hospital ( Site 0111) — Highlands Ranch
- Colorado Clinical Research ( Site 0067) — Lakewood
- University of Colorado Health - Lone Tree Medical Center ( Site 0112) — Lone Tree
California
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) — Orange
- Stanford Cancer Center ( Site 0036) — Palo Alto
- Kaiser Permanente Riverside Medical Center ( Site 0099) — Riverside
Florida
- Florida Cancer Specialists - South ( Site 7003) — Fort Myers
- Bruce W. Carter Veterans Affairs Medical Center ( Site 0082) — Miami
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051) — Miami
Illinois
- University of Illinois at Chicago ( Site 0105) — Chicago
- University of Chicago Medical Center ( Site 0045) — Chicago
Maryland
- Baltimore Veterans Affairs Medical Center ( Site 0069) — Baltimore
- Greenebaum Comprehensive Cancer Center ( Site 0049) — Baltimore
Connecticut
- Yale-New Haven Hospital-Yale Cancer Center ( Site 0064) — New Haven
Iowa
- University of Iowa ( Site 0047) — Iowa City
Kentucky
- University of Kentucky Chandler Medical Center ( Site 0048) — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,310 participants |
| Start Date | 2023-12-31 |
| Est. Completion | 2028-08-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06136624
The ClinicalTrials.gov registry entry for NCT06136624 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,310 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prostate Cancer Metastatic appearing as the primary indexed condition, and to 5 interventions — of which Enzalutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06136624 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Colorado, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06136624 about?
NCT06136624 is a clinical study titled "Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)". 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-genera...
What is the current status of trial NCT06136624?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,310 participants. The study started on 2023-12-31. Estimated completion is 2028-08-02.
What conditions does trial NCT06136624 study?
This clinical trial studies the following conditions: Prostate Cancer Metastatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06136624?
The interventions under investigation include: Enzalutamide (DRUG), Hydrocortisone (DRUG), Abiraterone acetate (DRUG), Opevesostat (DRUG), Fludrocortisone acetate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06136624?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06136624 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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