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)
Public ClinicalTrials.gov record NCT06136650. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.
Study identification
- NCT ID
- NCT06136650
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,314 participants
Conditions and interventions
Interventions
- Opevesostat Drug
- Dexamethasone Drug
- Fludrocortisone acetate Drug
- Hydrocortisone Drug
- Abiraterone acetate Drug
- Prednisone acetate Drug
- Enzalutamide Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 17, 2023
- Primary completion
- May 9, 2028
- Completion
- Dec 1, 2030
- Last update posted
- Aug 23, 2026
2023 – 2030
United States locations
- U.S. sites
- 63
- U.S. states
- 27
- U.S. cities
- 59
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center - North Campus ( Site 0073) | Tucson | Arizona | 85719 | Recruiting |
| CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 0120) | Irvine | California | 92612 | Recruiting |
| UCLA Hematology/Oncology - Santa Monica ( Site 0044) | Los Angeles | California | 90404 | Recruiting |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) | Orange | California | 92868 | Recruiting |
| Stanford Cancer Center ( Site 0036) | Palo Alto | California | 94304 | Recruiting |
| Emad Ibrahim,MD,INC. ( Site 0012) | Redlands | California | 92373 | Completed |
| Kaiser Permanente Riverside Medical Center ( Site 0099) | Riverside | California | 92505 | Recruiting |
| University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114) | Sacramento | California | 95817 | Recruiting |
| San Francisco VA Health Care System ( Site 0093) | San Francisco | California | 94121 | Recruiting |
| Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101) | Vallejo | California | 94589 | Recruiting |
| University of Colorado Anschutz Medical Campus ( Site 0046) | Aurora | Colorado | 80045 | Recruiting |
| UCHealth Highlands Ranch Hospital ( Site 0111) | Highlands Ranch | Colorado | 80129 | Recruiting |
| Colorado Clinical Research ( Site 0067) | Lakewood | Colorado | 80228 | Recruiting |
| University of Colorado Health - Lone Tree Medical Center ( Site 0112) | Lone Tree | Colorado | 80124 | Recruiting |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 0064) | New Haven | Connecticut | 06510 | Recruiting |
| MedStar Washington Hospital Center ( Site 0103) | Washington D.C. | District of Columbia | 20010 | Recruiting |
| Florida Cancer Specialists - South ( Site 7003) | Fort Myers | Florida | 33901 | Recruiting |
| Mount Sinai Braman Comprehensive Cancer Center ( Site 0107) | Miami Beach | Florida | 33140 | Recruiting |
| Memorial Hospital West-Memorial Cancer Institute ( Site 0109) | Pembroke Pines | Florida | 33028 | Recruiting |
| Northside Hospital-Northside Hospital Oncology Network ( Site 0100) | Atlanta | Georgia | 30342 | Active, not recruiting |
| Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074) | Elmhurst | Illinois | 60126 | Completed |
| Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075) | Naperville | Illinois | 60540 | Completed |
| Illinois Cancer Care ( Site 0104) | Peoria | Illinois | 61615 | Recruiting |
| Urology of Indiana - Carmel ( Site 0055) | Carmel | Indiana | 46032 | Recruiting |
| University of Kentucky Chandler Medical Center ( Site 0048) | Lexington | Kentucky | 40536 | Active, not recruiting |
| Baltimore Veterans Affairs Medical Center ( Site 0069) | Baltimore | Maryland | 21201 | Recruiting |
| Greenebaum Comprehensive Cancer Center ( Site 0049) | Baltimore | Maryland | 21201 | Recruiting |
| Chesapeake Urology ( Site 0009) | Towson | Maryland | 21204 | Recruiting |
| Henry Ford Hospital ( Site 0015) | Detroit | Michigan | 48202 | Recruiting |
| Cancer and Hematology Centers of Western Michigan ( Site 0005) | Grand Rapids | Michigan | 49503 | Recruiting |
| Avera Cancer Institute - Marshall ( Site 0122) | Marshall | Minnesota | 56258 | Recruiting |
| HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072) | Saint Louis Park | Minnesota | 55426 | Recruiting |
| HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092) | Saint Paul | Minnesota | 55101 | Recruiting |
| St. Vincent Frontier Cancer Center-Research ( Site 0037) | Billings | Montana | 59102 | Recruiting |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026) | Omaha | Nebraska | 68130 | Recruiting |
| OptumCare Cancer Care-Research Department ( Site 0078) | Las Vegas | Nevada | 89102 | Recruiting |
| Comprehensive Cancer Centers of Nevada ( Site 0010) | Las Vegas | Nevada | 89148 | Recruiting |
| Rutgers Cancer Institute of New Jersey ( Site 0033) | New Brunswick | New Jersey | 08903 | Recruiting |
| Associated Medical Professionals - Urology ( Site 0081) | Syracuse | New York | 13210 | Recruiting |
| University Hospitals Cleveland Medical Center ( Site 0043) | Cleveland | Ohio | 44106 | Recruiting |
| Central Ohio Urology Group - Gahanna ( Site 0098) | Gahanna | Ohio | 43230 | Completed |
| Genesis Healthcare System ( Site 0102) | Zanesville | Ohio | 43701 | Completed |
| MidLantic urology ( Site 0022) | Bala-Cynwyd | Pennsylvania | 19004 | Recruiting |
| Fox Chase Cancer Center ( Site 0076) | Philadelphia | Pennsylvania | 19111 | Recruiting |
| Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083) | Charleston | South Carolina | 29401 | Recruiting |
| Avera Cancer Institute - Aberdeen ( Site 0123) | Aberdeen | South Dakota | 57401 | Recruiting |
| Avera Cancer Institute - Mitchell ( Site 0121) | Mitchell | South Dakota | 57301 | Recruiting |
| Avera Cancer Institute - Pierre ( Site 0118) | Pierre | South Dakota | 57501 | Recruiting |
| Avera Cancer Institute- Research ( Site 0094) | Sioux Falls | South Dakota | 57105 | Recruiting |
| Avera Cancer Institute - Yankton ( Site 0117) | Yankton | South Dakota | 57078 | Recruiting |
| The West Clinic, PLLC dba West Cancer Center ( Site 0063) | Germantown | Tennessee | 38138 | Recruiting |
| Texas Oncology - Central/South Texas ( Site 8003) | Austin | Texas | 78731 | Recruiting |
| Cancer Clinics of North Texas ( Site 0077) | Dallas | Texas | 75243 | Completed |
| Texas Oncology - DFW ( Site 8001) | Dallas | Texas | 75246 | Recruiting |
| Texas Oncology - Gulf Coast ( Site 8002) | Houston | Texas | 77024 | Recruiting |
| University of Virginia Health System ( Site 0054) | Charlottesville | Virginia | 22908 | Recruiting |
| Inova Schar Cancer Institute ( Site 0017) | Fairfax | Virginia | 22031 | Recruiting |
| Virginia Cancer Specialists (VCS) ( Site 8004) | Fairfax | Virginia | 22031 | Recruiting |
| VCU Health Adult Outpatient Pavillion ( Site 0061) | Richmond | Virginia | 23219 | Recruiting |
| Blue Ridge Cancer Care ( Site 0004) | Roanoke | Virginia | 24014 | Recruiting |
| Spokane Urology ( Site 0035) | Spokane | Washington | 99202 | Recruiting |
| Northwest Cancer Specialists (Compass Oncology) ( Site 8008) | Vancouver | Washington | 98684 | Recruiting |
| Medical College of Wisconsin ( Site 0020) | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 267 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06136650, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 23, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06136650 live on ClinicalTrials.gov.