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)
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)
5 other identifiers
interventional
1,314
37 countries
317
Brief Summary
The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2023
Longer than P75 for phase_3
317 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
December 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 2, 2030
May 5, 2026
May 1, 2026
4.4 years
November 13, 2023
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Radiographic Progression-Free Survival (rPFS)
rPFS is defined as the time from randomization to the first documented disease progression per PCWG-modified RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Up to approximately 52 months
Secondary Outcomes (13)
Overall Survival (OS)
Up to approximately 82 months
Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
Up to approximately 82 months
Objective Response Rate (ORR)
Up to approximately 82 months
Duration of Response (DOR)
Up to approximately 82 months
Time to Pain Progression (TTPP)
Up to approximately 82 months
- +8 more secondary outcomes
Study Arms (2)
Hormone Replacement Therapy (HRT) + Opevesostat
EXPERIMENTALParticipants receive opevesostat 5 mg by oral tablets twice daily (BID) plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily (QD) continuously until disease progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) will also be provided to participants for use as rescue medication.
Alternative Next-Generation Hormonal Agent (NHA)
ACTIVE COMPARATORParticipants receive abiraterone 1000mg QD by oral tablets plus prednisone 5 mg BID by oral tablets or enzalutamide 160 mg QD by oral tablets until disease progression.
Interventions
Administered orally or IM as a rescue drug
Administered orally
Administered orally
Administered orally
Eligibility Criteria
You may qualify if:
- Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
- Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI)
- Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \[mHSPC\] or non-metastatic hormone-sensitive prostate cancer \[nmHSPC\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \[mCRPC\] or non-metastatic castration-resistant prostate cancer \[nmCRPC\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
- Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
- Has ongoing androgen deprivation therapy (ADT) with serum testosterone \<50 ng/dL (\<1.7 nM)
- Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization
- Has adequate organ function
- Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
You may not qualify if:
- Has presence of gastrointestinal condition
- Is unable to swallow capsules/tablets
- Has history of pituitary dysfunction
- Has poorly controlled diabetes mellitus
- Has clinically significant abnormal serum potassium or sodium level
- Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \<110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy
- Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events
- History or family history of long QTc syndrome
- Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
- Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
- Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
- Has not adequately recovered from major surgery or have ongoing surgical complications
- Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
- Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention
- Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orion Corporation, Orion Pharmacollaborator
- Merck Sharp & Dohme LLClead
Study Sites (324)
The University of Arizona Cancer Center - North Campus ( Site 0073)
Tucson, Arizona, 85719, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0044)
Los Angeles, California, 90404, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)
Orange, California, 92868, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120)
Orange, California, 92868, United States
Stanford Cancer Center ( Site 0036)
Palo Alto, California, 94304, United States
Emad Ibrahim,MD,INC. ( Site 0012)
Redlands, California, 92373, United States
Kaiser Permanente Riverside Medical Center ( Site 0099)
Riverside, California, 92505, United States
University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114)
Sacramento, California, 95817, United States
San Francisco VA Health Care System ( Site 0093)
San Francisco, California, 94121, United States
Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)
Vallejo, California, 94589, United States
University of Colorado Anschutz Medical Campus ( Site 0046)
Aurora, Colorado, 80045, United States
UCHealth Highlands Ranch Hospital ( Site 0111)
Highlands Ranch, Colorado, 80129, United States
Colorado Clinical Research ( Site 0067)
Lakewood, Colorado, 80228, United States
University of Colorado Health - Lone Tree Medical Center ( Site 0112)
Lone Tree, Colorado, 80124, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)
New Haven, Connecticut, 06510, United States
MedStar Washington Hospital Center ( Site 0103)
Washington D.C., District of Columbia, 20010, United States
Florida Cancer Specialists - South ( Site 7003)
Fort Myers, Florida, 33901, United States
Mount Sinai Cancer Center ( Site 0107)
Miami Beach, Florida, 33140, United States
Memorial Hospital West-Memorial Cancer Institute ( Site 0109)
Pembroke Pines, Florida, 33028, United States
Northside Hospital-Northside Hospital Oncology Network ( Site 0100)
Atlanta, Georgia, 30342, United States
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074)
Elmhurst, Illinois, 60126, United States
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075)
Naperville, Illinois, 60540, United States
Illinois Cancer Care ( Site 0104)
Peoria, Illinois, 61615, United States
Urology of Indiana - Carmel ( Site 0055)
Carmel, Indiana, 46032, United States
University of Kentucky Chandler Medical Center ( Site 0048)
Lexington, Kentucky, 40536, United States
Baltimore Veterans Affairs Medical Center ( Site 0069)
Baltimore, Maryland, 21201, United States
Greenebaum Comprehensive Cancer Center ( Site 0049)
Baltimore, Maryland, 21201, United States
Chesapeake Urology ( Site 0009)
Towson, Maryland, 21204, United States
Henry Ford Hospital ( Site 0015)
Detroit, Michigan, 48202, United States
Cancer and Hematology Centers of Western Michigan ( Site 0005)
Grand Rapids, Michigan, 49503, United States
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072)
Saint Louis Park, Minnesota, 55426, United States
HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092)
Saint Paul, Minnesota, 55101, United States
St. Vincent Frontier Cancer Center-Research ( Site 0037)
Billings, Montana, 59102, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
Omaha, Nebraska, 68130, United States
OptumCare Cancer Care-Research Department ( Site 0078)
Las Vegas, Nevada, 89102, United States
Comprehensive Cancer Centers of Nevada ( Site 0010)
Las Vegas, Nevada, 89148, United States
Rutgers Cancer Institute of New Jersey ( Site 0033)
New Brunswick, New Jersey, 08901, United States
Associated Medical Professionals - Urology ( Site 0081)
Syracuse, New York, 13210, United States
University Hospitals Cleveland Medical Center ( Site 0043)
Cleveland, Ohio, 44106, United States
Central Ohio Urology Group - Gahanna ( Site 0098)
Gahanna, Ohio, 43230, United States
Genesis Healthcare System ( Site 0102)
Zanesville, Ohio, 43701, United States
MidLantic urology ( Site 0022)
Bala-Cynwyd, Pennsylvania, 19004, United States
Fox Chase Cancer Center ( Site 0076)
Philadelphia, Pennsylvania, 19111, United States
Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)
Charleston, South Carolina, 29401, United States
Avera Cancer Institute - Pierre ( Site 0118)
Pierre, South Dakota, 57501, United States
Avera Cancer Institute- Research ( Site 0094)
Sioux Falls, South Dakota, 57105, United States
Avera Cancer Institute - Yankton ( Site 0117)
Yankton, South Dakota, 57078, United States
The West Clinic, PLLC dba West Cancer Center ( Site 0063)
Germantown, Tennessee, 38138, United States
Texas Oncology - Central/South Texas ( Site 8003)
Austin, Texas, 78731, United States
Texas Oncology - DFW ( Site 8001)
Dallas, Texas, 75246, United States
Texas Oncology - Gulf Coast ( Site 8002)
Houston, Texas, 77024, United States
University of Virginia Health System ( Site 0054)
Charlottesville, Virginia, 22908, United States
Inova Schar Cancer Institute ( Site 0017)
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists (VCS) ( Site 8004)
Fairfax, Virginia, 22031, United States
VCU Health Adult Outpatient Pavillion ( Site 0061)
Richmond, Virginia, 23219, United States
Blue Ridge Cancer Care ( Site 0004)
Roanoke, Virginia, 24014, United States
Spokane Urology ( Site 0035)
Spokane, Washington, 99202, United States
Northwest Cancer Specialists (Compass Oncology) ( Site 8008)
Vancouver, Washington, 98684, United States
MEDICAL COLLEGE OF WISCONSIN ( Site 0020)
Milwaukee, Wisconsin, 53226, United States
Macquarie University-MQ Health Clinical Trials Unit ( Site 0214)
Macquarie University, New South Wales, 2109, Australia
Westmead Hospital ( Site 0212)
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0211)
Brisbane, Queensland, 4029, Australia
Monash Health ( Site 0219)
Clayton, Victoria, 3168, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210)
Melbourne, Victoria, 3000, Australia
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0256)
Fortaleza, Ceará, 60336-232, Brazil
Hospital Santa Rita de Cassia ( Site 0271)
Vitória, Espírito Santo, 29043-260, Brazil
Obras Sociais Irma Dulce ( Site 0255)
Salvador, Estado de Bahia, 40415-006, Brazil
Hospital São Domingos ( Site 0258)
São Luís, Maranhão, 65060-645, Brazil
Hospital Mario Penna ( Site 0264)
Belo Horizonte, Minas Gerais, 30380-472, Brazil
Universidade Federal do Triangulo Mineiro - Hospital de Clinicas ( Site 0262)
Uberaba, Minas Gerais, 38025-350, Brazil
ICTRIALS Pesquisa e Desenvolvimento ( Site 0274)
Curitiba, Paraná, 80510-130, Brazil
Hospital Universitário Evangélico Mackenzie ( Site 0252)
Curitiba, Paraná, 80730-150, Brazil
Hospital São Lucas da PUCRS ( Site 0270)
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Clínica de Neoplasias Litoral ( Site 0269)
Itajaí, Santa Catarina, 88301-220, Brazil
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0251)
Bragança Paulista, São Paulo, 12916-542, Brazil
Hospital de Base de São José do Rio Preto ( Site 0275)
São José do Rio Preto, São Paulo, 15090-000, Brazil
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0263)
Taubaté, São Paulo, 12030-200, Brazil
Hospital Paulistano ( Site 0259)
São Paulo, 01321-001, Brazil
Cross Cancer Institute (Site 0281)
Edmonton, Alberta, T6G 1Z2, Canada
Trillium Health Partners - Credit Valley Hospital ( Site 0289)
Mississauga, Ontario, L5M 2N1, Canada
The Ottawa Hospital - General Campus ( Site 0286)
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Research Institute ( Site 0285)
Toronto, Ontario, M4N 3M5, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0276)
Montreal, Quebec, H2X 3E4, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0277)
Québec, Quebec, G1J 1Z4, Canada
CIDO SpA-Oncology ( Site 0302)
Temuco, Araucania, 4810218, Chile
Clinica Universidad Catolica del Maule-Oncology ( Site 0306)
Talca, Maule Region, 3465584, Chile
FALP ( Site 0303)
Santiago, Region M. de Santiago, 7500921, Chile
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0304)
Santiago, Region M. de Santiago, 8330024, Chile
Bradfordhill-Clinical Area ( Site 0301)
Santiago, Region M. de Santiago, 8420383, Chile
ONCOCENTRO APYS-ACEREY ( Site 0305)
Viña del Mar, Valparaiso, 2520598, Chile
The Second Hospital Of Anhui Medical University ( Site 1633)
Hefei, Anhui, 230000, China
Peking University First Hospital-Urology ( Site 1602)
Beijing, Beijing Municipality, 100034, China
Beijing Cancer hospital-Urinary Surgery ( Site 1620)
Beijing, Beijing Municipality, 100142, China
First Medical Center of Chinese PLA General Hospital ( Site 1601)
Beijing, Beijing Municipality, 100853, China
Beijing Cancer Hospital ( Site 1623)
Beijing, Beijing Municipality, 130021, China
Chongqing University Cancer Hospital ( Site 1603)
Chongqing, Chongqing Municipality, 400030, China
Southwest Hospital of Third Military Medical University ( Site 1645)
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 1639)
Fuzhou, Fujian, 350005, China
The first affiliated hospital of Guangzhou medical university ( Site 1637)
Guangzhou, Guangdong, 510030, China
Sun Yat-sen University Cancer Center-Urology Surgery ( Site 1638)
Guangzhou, Guangdong, 510700, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 1632)
Wuhan, Hubei, 430000, China
The Central Hospital of Wuhan ( Site 1635)
Wuhan, Hubei, 430014, China
Hubei Cancer Hospital-Urinary surgery ( Site 1631)
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital ( Site 1630)
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1615)
Nanjing, Jiangsu, 210008, China
Nantong Tumor Hospital-Urology ( Site 1609)
Nantong, Jiangsu, 226361, China
Wuxi People's Hospital ( Site 1612)
Wuxi, Jiangsu, 214023, China
The Second Affiliated Hospital of Xi'an Jiaotong University-Oncology Department ( Site 1619)
Xi'an, Shaanxi, 710004, China
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology department ( Site 1618)
Xi'an, Shaanxi, 710061, China
Yantai Yuhuangding Hospital ( Site 1622)
Yantai, Shandong, 264099, China
Renji Hosp Shanghai Jiaotong U School of Med ( Site 1624)
Shanghai, Shanghai Municipality, 200001, China
Huadong Hospital Affiliated to Fudan University-Urology ( Site 1613)
Shanghai, Shanghai Municipality, 200041, China
West China Hospital, Sichuan University-Urology Surgery ( Site 1642)
Chengdu, Sichuan, 610041, China
Nanchong Central Hospital-urology ( Site 1647)
Nanchong, Sichuan, 500643, China
The Second Hospital of Tianjin Medical University ( Site 1616)
Tianjin, Tianjin Municipality, 300211, China
Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 1644)
Ürümqi, Xinjiang, 830000, China
Yunnan Province Cancer Hospital ( Site 1643)
Kunming, Yunnan, 650107, China
Zhejiang Provincial People's Hospital-Urology ( Site 1641)
Hangzhou, Zhejiang, 310014, China
The First Hospital of Jiaxing-urology ( Site 1605)
Jiaxing, Zhejiang, 314001, China
Ningbo First Hospital-Urology ( Site 1608)
Ningbo, Zhejiang, 315010, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 1604)
Wenzhou, Zhejiang, 325015, China
Los Cobos Medical Center ( Site 0336)
Bogotá, Bogota D.C., 110121, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0326)
Bogotá, Bogota D.C., 111321, Colombia
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0327)
Valledupar, Cesar Department, 200001, Colombia
IMAT S.A.S ( Site 0329)
Montería, Departamento de Córdoba, 230002, Colombia
Fundación Cardiovascular de Colombia ( Site 0328)
Piedecuesta, Santander Department, 681017, Colombia
Fundación Valle del Lili ( Site 0330)
Cali, Valle del Cauca Department, 760032, Colombia
Clínica Imbanaco S.A.S ( Site 0334)
Cali, Valle del Cauca Department, 760042, Colombia
CIMCA-Hemato-Oncology ( Site 0380)
San José, Provincia de San José, 10103, Costa Rica
Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0379)
Santa Ana, Provincia de San José, 10903, Costa Rica
Onco Tech, S.A. ( Site 0376)
San José, 10103, Costa Rica
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0403)
Brno, Brno-mesto, 656 53, Czechia
Krajská nemocnice Liberec-Department of Urology ( Site 0407)
Liberec, Liberec Region, 460 01, Czechia
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0401)
Prague, Praha 5, 150 06, Czechia
Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0404)
Brno, South Moravian, 602 00, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0405)
Olomouc, 77900, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 0406)
Prague, 12808, Czechia
East-Tallinn Central Hospital ( Site 1528)
Tallinn, Harju, 11314, Estonia
North Estonia Medical Centre Foundation ( Site 1526)
Tallinn, Harju, 13419, Estonia
Pärnu Haigla (Site 1550)
Pärnu, Pärnumaa, 80010, Estonia
Tartu University Hospital-Radiotherapy and oncology ( Site 1527)
Tartu, Tartu, 50406, Estonia
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0451)
Strasbourg, Alsace, 67200, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0461)
Bordeaux, Aquitaine, 33076, France
CENTRE LEON BERARD ( Site 0459)
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France
CHU-BREST Cavale Blanche ( Site 0456)
Brest, Finistere, 29609, France
Ramsay Santé - Clinical La Croix Du Sud ( Site 0460)
Quint-Fonsegrives, Haute-Garonne, 31130, France
Centre Bourgogne ( Site 0464)
Lille, Hauts-de-France, 59000, France
Hôpital Foch ( Site 0455)
Suresnes, Hauts-de-Seine, 92150, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0454)
Clermont-Ferrand, Puy-de-Dome, 63003, France
Gustave Roussy ( Site 0452)
Villejuif, Val-de-Marne, 94800, France
Sainte Catherine Institut du Cancer Avignon Provence ( Site 0458)
Avignon, Vaucluse, 84000, France
Groupe Hospitalier Paris Saint Joseph ( Site 0465)
Paris, 75014, France
Universitaetsklinikum Freiburg-Klinik für Urologie ( Site 0506)
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitaetsklinikum Heidelberg ( Site 0531)
Heidelberg, Baden-Wurttemberg, 69120, Germany
Studienpraxis Urologie ( Site 0529)
Nürtingen, Baden-Wurttemberg, 72622, Germany
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0521)
Munich, Bavaria, 81675, Germany
Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0523)
Regensburg, Bavaria, 93053, Germany
Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 0510)
Marburg, Hesse, 35043, Germany
Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Urologie ( Site 0527)
Göttingen, Lower Saxony, 37075, Germany
Marien-Krankenhaus ( Site 0515)
Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany
Universitaetsklinikum Koeln ( Site 0518)
Cologne, North Rhine-Westphalia, 50937, Germany
Urologicum Duisburg (Site 00538)
Duisburg, North Rhine-Westphalia, 47169, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0528)
Dresden, Saxony, 01307, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)
Berlin, 10117, Germany
Vivantes Klinikum Am Urban ( Site 0512)
Berlin, 10967, Germany
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0553)
Pátrai, Achaia, 26504, Greece
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0551)
Athens, Attica, 115 28, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Site 0552)
Chaïdári, Attica, 124 62, Greece
MEDI-K ( Site 0576)
Guatemala City, 01009, Guatemala
CELAN,S.A ( Site 0579)
Guatemala City, 01010, Guatemala
INTEGRA Cancer Institute-Oncology ( Site 0578)
Guatemala City, 01010, Guatemala
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0577)
Guatemala City, 01010, Guatemala
Sanatorio Nuestra Senora del Pilar ( Site 0580)
Guatemala City, 01015, Guatemala
Hong Kong Integrated Oncology Centre ( Site 0603)
Central, 999077, Hong Kong
Queen Mary Hospital ( Site 0602)
Hong Kong, Hong Kong
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C ( Site 0630)
Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary
Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0636)
Salgótarján, Nógrád megye, 3100, Hungary
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0631)
Budapest, Pest County, 1122, Hungary
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0632)
Debrecen, 4032, Hungary
St. Vincent's University Hospital ( Site 0652)
Dublin, Dublin, D04 T6F4, Ireland
Tallaght University Hospital ( Site 0651)
Dublin, D24 NR0A, Ireland
Emek Medical Center ( Site 0680)
Afula, 1834111, Israel
Rambam Health Care Campus-Oncology Division ( Site 0676)
Haifa, 3109601, Israel
Shaare Zedek Medical Center ( Site 0679)
Jerusalem, 9103102, Israel
Hadassah Medical Center ( Site 0683)
Jerusalem, 9112001, Israel
Meir Medical Center. ( Site 0682)
Kfar Saba, 4428164, Israel
Rabin Medical Center ( Site 0678)
Petah Tikva, 4941492, Israel
Sheba Medical Center ( Site 0677)
Ramat Gan, 5265601, Israel
Sourasky Medical Center ( Site 0681)
Tel Aviv, 6423906, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1454)
Meldola, Emilia-Romagna, 47014, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1452)
Milan, Lombardy, 20133, Italy
Ospedale Cannizzaro ( Site 1455)
Catania, 95126, Italy
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 1456)
Foggia, 71100, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1451)
Milan, 20132, Italy
Azienda Ospedaliera Santa Maria Terni ( Site 1458)
Terni, 05100, Italy
Toho University Sakura Medical Center ( Site 0730)
Sakura, Chiba, 285-8741, Japan
University of Fukui Hospital ( Site 0735)
Eiheiji-cho,Yoshida-gun, Fukui, 910-1193, Japan
Hospital of the University of Occupational and Environmental Health, Japan ( Site 0746)
Kitakyushu, Fukuoka, 807-8556, Japan
Sapporo Medical University Hospital ( Site 0726)
Sapporo, Hokkaido, 060-8543, Japan
Hokkaido University Hospital ( Site 0756)
Sapporo, Hokkaido, 060-8648, Japan
Kobe University Hospital ( Site 0741)
Kobe, Hyōgo, 650-0017, Japan
Kanazawa Medical University Hospital ( Site 0734)
Mukai-awagasaki, Ishikawa-ken, 920-0265, Japan
Kagawa University Hospital ( Site 0744)
Kita, Kagawa-ken, 761-0701, Japan
Yokohama City University Medical Center ( Site 0733)
Yokohama, Kanagawa, 232-0024, Japan
Mie University Hospital ( Site 0737)
Tsu, Mie-ken, 514-8507, Japan
National Hospital Organization Nagasaki Medical Center ( Site 0748)
Ōmura, Nagasaki, 856-8562, Japan
Nara Medical University Hospital ( Site 0742)
Kashihara, Nara, 634-8522, Japan
Nanbu Tokushukai Hospital ( Site 0755)
Shimajiri, Okinawa, 901-0417, Japan
Kansai Medical University Hospital ( Site 0739)
Hirakata, Osaka, 573-1191, Japan
Bell Land General Hospital ( Site 0740)
Sakai, Osaka, 599-8247, Japan
The University of Osaka Hospital ( Site 0738)
Suita, Osaka, 565-0871, Japan
Saga-Ken Medical Centre Koseikan ( Site 0747)
Saga, Saga-ken, 840-8571, Japan
Nihon University Itabashi Hospital ( Site 0732)
Itabashiku, Tokyo, 173-8610, Japan
The Jikei University Hospital ( Site 0731)
Minato, Tokyo, 105-8471, Japan
Akita University Hospital ( Site 0728)
Akita, 010-8543, Japan
Kyushu University Hospital ( Site 0745)
Fukuoka, 812-8582, Japan
Fukushima Medical University Hospital ( Site 0758)
Fukushima, 960-1295, Japan
Gifu University Hospital ( Site 0736)
Gifu, 501-1112, Japan
Hiroshima University Hospital ( Site 0743)
Hiroshima, 734-8551, Japan
Kagoshima University Hospital ( Site 0754)
Kagoshima, 890-8520, Japan
National Hospital Organization Kumamoto Medical Center ( Site 0749)
Kumamoto, 860-0008, Japan
Miyazaki Prefectural Miyazaki Hospital ( Site 0752)
Miyazaki, 880-8510, Japan
University of Miyazaki Hospital ( Site 0751)
Miyazaki, 889-1692, Japan
Nagano Municipal Hospital ( Site 0757)
Nagano, 381-8551, Japan
National Hospital Organization Oita Medical Center ( Site 0750)
Ōita, 870-0263, Japan
Liepaja Regional Hospital ( Site 1553)
Liepāja, LV3414, Latvia
Pauls Stradins Clinical Univeristy Hospital-Urological department ( Site 1551)
Riga, LV-1002, Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 1576)
Kaunas, Kaunas County, 50161, Lithuania
National Cancer Institute ( Site 1577)
Vilnius, Vilniaus Miestas, 08660, Lithuania
Hospital Sultan Ismail ( Site 0905)
Johor Bahru, Johor, 81100, Malaysia
University Malaya Medical Centre ( Site 0902)
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
National Cancer Institute ( Site 0904)
Putrajaya, Putrajaya, 62250, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 0901)
Kuching, Sarawak, 93586, Malaysia
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 0903)
Kuala Lumpur, 50586, Malaysia
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0928)
Guadalajara, Jalisco, 44630, Mexico
Health Pharma Professional Research S.A. de C.V: ( Site 0929)
Mexico City, Mexico City, 03100, Mexico
Higiea Oncologia ( Site 0938)
Mexico City, Mexico City, 11810, Mexico
Quemex Medical and Research ( Site 0937)
Tlalpan, Mexico City, 14308, Mexico
Filios Alta Medicina ( Site 0931)
Monterrey, Nuevo León, 64460, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0932)
Monterrey, Nuevo León, 64460, Mexico
Eukarya Pharmasite S.C. ( Site 0939)
Monterrey, Nuevo León, 64718, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0934)
Oaxaca City, Oaxaca, 68020, Mexico
Dunedin Hospital ( Site 1032)
Dunedin, Otago, 9016, New Zealand
Auckland City Hospital ( Site 1033)
Auckland, 1023, New Zealand
Aliada-Oncologìa ( Site 1055)
Lima, 15036, Peru
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1052)
Lima, 15036, Peru
Oncosalud-Clinical Research ( Site 1057)
Lima, 15036, Peru
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1054)
Lima, 15038, Peru
Hospital de Cascais Doutor José de Almeida ( Site 1158)
Alcabideche, Lisbon District, 2755-009, Portugal
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1156)
Vila Nova de Gaia, Porto District, 4434-502, Portugal
Unidade Local de Saude de Braga - Hospital de Braga ( Site 1151)
Braga, 4710-243, Portugal
Hospital CUF - Tejo ( Site 1157)
Lisbon, 1350-352, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1153)
Lisbon, 1649-035, Portugal
Unidade Local de Saude de Santo António - Hospital Santo António ( Site 1152)
Porto, 4099-001, Portugal
Advance Urology and Laparoscopic Center ( Site 1178)
Ponce, 00716, Puerto Rico
Ad-Vance Medical Research-Research ( Site 1177)
Ponce, 00717, Puerto Rico
Pan American Center for Oncology Trials - Ciudadela ( Site 1176)
San Juan, 00909, Puerto Rico
Spitalul Universitar de Urgență Elias ( Site 1504)
Bucharest, Bucharest, 011461, Romania
Cardiomed SRL Cluj-Napoca ( Site 1503)
Cluj-Napoca, Cluj, 400015, Romania
SC Radiotherapy Center Cluj SRL ( Site 1502)
Florești, Cluj, 407280, Romania
Centrul de Oncologie "Sfântul Nectarie" ( Site 1501)
Craiova, Dolj, 200746, Romania
Spitalul Clinic ''Prof Dr. Theodor Burghele" (Site 1505)
Bucharest, 050659, Romania
National University Hospital ( Site 1201)
Singapore, Central Singapore, 119074, Singapore
National Cancer Centre Singapore ( Site 1202)
Singapore, Central Singapore, 168583, Singapore
Singapore General Hospital ( Site 1204)
Singapore, Central Singapore, 169608, Singapore
Tan Tock Seng Hospital-Medical Oncology ( Site 1203)
Singapore, Central Singapore, 308433, Singapore
UROEXAM ( Site 1479)
Nitra, Nitra Region, 949 01, Slovakia
Privatna Urologicka Ambulancia ( Site 1478)
Trenčín, Trenčín Region, 911 01, Slovakia
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1230)
Port Elizabeth, Eastern Cape, 6055, South Africa
Wits Clinical Research ( Site 1234)
Johannesburg, Gauteng, 2193, South Africa
Wilgers Oncology Centre ( Site 1232)
Pretoria, Gauteng, 0040, South Africa
Curo Oncology. ( Site 1237)
Pretoria, Gauteng, 0084, South Africa
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1236)
Pretoria, Gauteng, 0181, South Africa
Cape Town Oncology Trials ( Site 1233)
Cape Town, Western Cape, 7570, South Africa
National Cancer Center-Center for Urologic Cancer ( Site 1254)
Goyang-si, Kyonggi-do, 10408, South Korea
Seoul National University Bundang Hospital-Urology ( Site 1253)
Seongnam, Kyonggi-do, 13620, South Korea
Kyungpook National University Chilgok Hospital-Urology ( Site 1252)
Buk-gu, Kyongsangbuk-do, 41404, South Korea
Pusan National University Yangsan Hospital ( Site 1256)
Pusan, Kyongsangnam-do, 50612, South Korea
Seoul National University Hospital-Urology ( Site 1251)
Seoul, 03080, South Korea
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1255)
Seoul, 06591, South Korea
Hospital Universitari Parc Tauli-oncologia ( Site 1282)
Sabadell, Barcelona, 08208, Spain
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1284)
Barcelona, Catalonia, 08036, Spain
Institut Català d'Oncologia (ICO) - Girona ( Site 1285)
Girona, Gerona, 17007, Spain
Complexo Hospitalario Universitario A Coruna ( Site 1288)
A Coruña, La Coruna, 15006, Spain
Hospital Insular de Gran Canaria-Oncology ( Site 1280)
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1283)
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario de Burgos-Oncología ( Site 1281)
Burgos, 09006, Spain
Hospital Quirón Málaga ( Site 1286)
Málaga, 29004, Spain
Karolinska Universitetssjukhuset Solna ( Site 1302)
Stockholm, Stockholm County, 171 64, Sweden
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1301)
Uppsala, Uppsala County, 751 85, Sweden
Chi Mei Medical Center ( Site 1336)
Tainan, Tainan, 71004, Taiwan
Kaohsiung Veterans General Hospital ( Site 1337)
Kaohsiung City, 81362, Taiwan
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1331)
Kaohsiung City, 83301, Taiwan
China Medical University Hospital-Department of Urology ( Site 1335)
Taichung, 40447, Taiwan
Taichung Veterans General Hospital ( Site 1338)
Taichung, 40705, Taiwan
Taipei Veterans General Hospital ( Site 1332)
Taipei, 112, Taiwan
Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1334)
Taoyuan, 333, Taiwan
Chulalongkorn University ( Site 1355)
Bangkok, Bangkok, 10330, Thailand
Faculty of Medicine Siriraj Hospital ( Site 1356)
Bangkok, Bangkok, 10700, Thailand
Faculty of Medicine - Khon Kaen University ( Site 1351)
Muang, Changwat Khon Kaen, 40002, Thailand
Songklanagarind hospital ( Site 1352)
Hat Yai, Changwat Songkhla, 90110, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 1353)
Muang, Chiang Mai, 50200, Thailand
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1379)
Adana, 01250, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1376)
Ankara, 06230, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1377)
Ankara, 06800, Turkey (Türkiye)
Koc Universitesi Hastanesi ( Site 1384)
Istanbul, 34010, Turkey (Türkiye)
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1381)
Istanbul, 34147, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1383)
Istanbul, 34668, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1378)
Istanbul, 34722, Turkey (Türkiye)
Ege Universitesi Hastanesi-Medical Oncology ( Site 1380)
Izmir, 35100, Turkey (Türkiye)
Samsun Medical Park Hastanesi-medical oncology ( Site 1382)
Samsun, 55200, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1426)
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Royal Derby Hospital ( Site 1431)
Derby, Derbyshire, DE22 3NE, United Kingdom
Torbay Hospital ( Site 1429)
Torquay, Devon, TQ2 7AA, United Kingdom
Mount Vernon Cancer Centre ( Site 1440)
Northwood, England, HA6 2RN, United Kingdom
The Royal Cornwall Hospital ( Site 1430)
Truro, England, TR1 3LJ, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1428)
Glasgow, Glasgow City, G12 0YN, United Kingdom
Charing Cross Hospital-Oncology Research ( Site 1434)
London, Hammersmith and Fulham, W6 8RF, United Kingdom
University College London Hospital ( Site 1437)
London, London, City of, NW1 2PG, United Kingdom
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435)
London, London, City of, SE1 9RT, United Kingdom
St. George's Hospital-Oncology ( Site 1441)
London, London, City of, SW17 0QT, United Kingdom
GenesisCare - Oxford ( Site 1442)
Oxford, Oxfordshire, OX4 6LB, United Kingdom
GenesisCare - Windsor ( Site 1443)
Windsor, Windsor And Maidenhead, SL4 3HD, United Kingdom
The Christie NHS Foundation Trust ( Site 1436)
Manchester, m20 4bx, United Kingdom
Related Publications (1)
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.
PMID: 41732008DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2023
First Posted
November 18, 2023
Study Start
December 18, 2023
Primary Completion (Estimated)
May 10, 2028
Study Completion (Estimated)
December 2, 2030
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf