Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06136624 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Prostate Cancer Metastatic, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 3
Development phase
1,310
Enrollment target
20
Study locations

NCT06136624: Recruiting Phase 3 study of Prostate Cancer Metastatic, sponsored by Merck Sharp & Dohme.

NCT06136624 is a Phase 3 study of Prostate Cancer Metastatic that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 1,310 participants, above the 151-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target (768% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06136624, a Phase 3 study of Prostate Cancer Metastatic, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 3
Development phase
1,310 participants
Enrollment target
20
Study locations

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.

Primary Outcome

OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-positive participants will be reported for each study arm.

Conditions Studied

Prostate Cancer Metastatic

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

FieldValue
Enrollment Target 1,310 participants
Start Date 2023-12-31
Est. Completion 2028-08-02
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What NCT06136624 shows while recruiting

NCT06136624 is an interventional study that assigns participants to a tested intervention. Its 1,310 participants enrollment target places it among the larger protocols in the corpus, above the 151-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target (768% higher).

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.

NCT06136624 names 20 study sites across 11 states, led by Colorado, California, Florida.

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.

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).

Who is sponsoring clinical trial NCT06136624?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Prostate Cancer Metastatic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06136624's enrollment target sits among peer trials

1,310 1st of 17 higher than 17 of 17 other Prostate Cancer Metastatic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer Metastatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT06556433 · 1,312 participants · NA

    Family-Based Financial Incentives Intervention for Smoking Cessation

  • NCT05176483 · 1,314 participants · Phase 1

    Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors

  • NCT06136650 · 1,314 participants · Phase 3

    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)

  • NCT06517901 · 1,306 participants · NA

    Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT06136624

Source: ClinicalTrials.gov NCT06136624, the US trial registry maintained by the National Library of Medicine. NCT06136624 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.