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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)

NCT06136650 · Merck Sharp & Dohme LLC
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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)
About this study
Per Protocol Amendment 08, overall survival (OS) was moved to be a secondary outcome measure.
Eligibility criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * 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) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * 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 * Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention * Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention * Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat * Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention * Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed * Active infection requiring systemic therapy * Has concurrent active Hepatitis B virus and Hepatitis C virus infection
Study design
Enrollment target: 1314 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-12-18
Estimated completion: 2030-12-02
Last updated: 2026-04-15
Interventions
Drug: OpevesostatDrug: DexamethasoneDrug: Fludrocortisone acetateDrug: HydrocortisoneDrug: Abiraterone acetateDrug: Prednisone acetateDrug: Enzalutamide
Primary outcomes
  • Radiographic Progression-Free Survival (rPFS) (Up to approximately 52 months)
Sponsor
Merck Sharp & Dohme LLC · industry
With: Orion Corporation, Orion Pharma
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (323)
The University of Arizona Cancer Center - North Campus ( Site 0073)Recruiting
Tucson, Arizona, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0044)Recruiting
Los Angeles, California, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)Recruiting
Orange, California, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120)Recruiting
Orange, California, United States
Stanford Cancer Center ( Site 0036)Recruiting
Palo Alto, California, United States
Emad Ibrahim,MD,INC. ( Site 0012)Completed
Redlands, California, United States
Kaiser Permanente Riverside Medical Center ( Site 0099)Recruiting
Riverside, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114)Recruiting
Sacramento, California, United States
San Francisco VA Health Care System ( Site 0093)Active Not Recruiting
San Francisco, California, United States
Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)Recruiting
Vallejo, California, United States
University of Colorado Anschutz Medical Campus ( Site 0046)Recruiting
Aurora, Colorado, United States
UCHealth Highlands Ranch Hospital ( Site 0111)Recruiting
Highlands Ranch, Colorado, United States
Colorado Clinical Research ( Site 0067)Recruiting
Lakewood, Colorado, United States
University of Colorado Health - Lone Tree Medical Center ( Site 0112)Recruiting
Lone Tree, Colorado, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)Recruiting
New Haven, Connecticut, United States
MedStar Washington Hospital Center ( Site 0103)Recruiting
Washington D.C., District of Columbia, United States
Florida Cancer Specialists - South ( Site 7003)Active Not Recruiting
Fort Myers, Florida, United States
Mount Sinai Cancer Center ( Site 0107)Recruiting
Miami Beach, Florida, United States
Memorial Hospital West-Memorial Cancer Institute ( Site 0109)Recruiting
Pembroke Pines, Florida, United States
Northside Hospital-Northside Hospital Oncology Network ( Site 0100)Recruiting
Atlanta, Georgia, United States
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074)Recruiting
Elmhurst, Illinois, United States
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075)Recruiting
Naperville, Illinois, United States
Illinois Cancer Care ( Site 0104)Recruiting
Peoria, Illinois, United States
Urology of Indiana - Carmel ( Site 0055)Recruiting
Carmel, Indiana, United States
University of Kentucky Chandler Medical Center ( Site 0048)Active Not Recruiting
Lexington, Kentucky, United States
Baltimore Veterans Affairs Medical Center ( Site 0069)Recruiting
Baltimore, Maryland, United States
Greenebaum Comprehensive Cancer Center ( Site 0049)Recruiting
Baltimore, Maryland, United States
Chesapeake Urology ( Site 0009)Recruiting
Towson, Maryland, United States
Henry Ford Hospital ( Site 0015)Recruiting
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan ( Site 0005)Recruiting
Grand Rapids, Michigan, United States
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072)Recruiting
Saint Louis Park, Minnesota, United States
HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092)Active Not Recruiting
Saint Paul, Minnesota, United States
St. Vincent Frontier Cancer Center-Research ( Site 0037)Recruiting
Billings, Montana, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)Recruiting
Omaha, Nebraska, United States
OptumCare Cancer Care-Research Department ( Site 0078)Recruiting
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada ( Site 0010)Recruiting
Las Vegas, Nevada, United States
Rutgers Cancer Institute of New Jersey ( Site 0033)Recruiting
New Brunswick, New Jersey, United States
Associated Medical Professionals - Urology ( Site 0081)Recruiting
Syracuse, New York, United States
University Hospitals Cleveland Medical Center ( Site 0043)Recruiting
Cleveland, Ohio, United States
Central Ohio Urology Group - Gahanna ( Site 0098)Active Not Recruiting
Gahanna, Ohio, United States
Genesis Healthcare System ( Site 0102)Recruiting
Zanesville, Ohio, United States
MidLantic urology ( Site 0022)Recruiting
Bala-Cynwyd, Pennsylvania, United States
Fox Chase Cancer Center ( Site 0076)Recruiting
Philadelphia, Pennsylvania, United States
Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)Recruiting
Charleston, South Carolina, United States
Avera Cancer Institute - Pierre ( Site 0118)Active Not Recruiting
Pierre, South Dakota, United States
Avera Cancer Institute- Research ( Site 0094)Recruiting
Sioux Falls, South Dakota, United States
Avera Cancer Institute - Yankton ( Site 0117)Recruiting
Yankton, South Dakota, United States
The West Clinic, PLLC dba West Cancer Center ( Site 0063)Recruiting
Germantown, Tennessee, United States
Texas Oncology - Central/South Texas ( Site 8003)Recruiting
Austin, Texas, United States
Texas Oncology - DFW ( Site 8001)Recruiting
Dallas, Texas, United States
Texas Oncology - Gulf Coast ( Site 8002)Recruiting
Houston, Texas, United States
University of Virginia Health System ( Site 0054)Recruiting
Charlottesville, Virginia, United States
Inova Schar Cancer Institute ( Site 0017)Recruiting
Fairfax, Virginia, United States
Virginia Cancer Specialists (VCS) ( Site 8004)Recruiting
Fairfax, Virginia, United States
VCU Health Adult Outpatient Pavillion ( Site 0061)Recruiting
Richmond, Virginia, United States
Blue Ridge Cancer Care ( Site 0004)Recruiting
Roanoke, Virginia, United States
Spokane Urology ( Site 0035)Recruiting
Spokane, Washington, United States
Northwest Cancer Specialists (Compass Oncology) ( Site 8008)Recruiting
Vancouver, Washington, United States
MEDICAL COLLEGE OF WISCONSIN ( Site 0020)Recruiting
Milwaukee, Wisconsin, United States
Macquarie University-MQ Health Clinical Trials Unit ( Site 0214)Recruiting
Macquarie University, New South Wales, Australia
Westmead Hospital ( Site 0212)Recruiting
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0211)Recruiting
Brisbane, Queensland, Australia
Monash Health ( Site 0219)Recruiting
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210)Recruiting
Melbourne, Victoria, Australia
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0256)Active Not Recruiting
Fortaleza, Ceará, Brazil
Hospital Santa Rita de Cassia ( Site 0271)Recruiting
Vitória, Espírito Santo, Brazil
Obras Sociais Irma Dulce ( Site 0255)Active Not Recruiting
Salvador, Estado de Bahia, Brazil
Hospital São Domingos ( Site 0258)Active Not Recruiting
São Luís, Maranhão, Brazil
Hospital Mario Penna ( Site 0264)Active Not Recruiting
Belo Horizonte, Minas Gerais, Brazil
Universidade Federal do Triangulo Mineiro - Hospital de Clinicas ( Site 0262)Recruiting
Uberaba, Minas Gerais, Brazil
ICTRIALS Pesquisa e Desenvolvimento ( Site 0274)Active Not Recruiting
Curitiba, Paraná, Brazil
Hospital Universitário Evangélico Mackenzie ( Site 0252)Active Not Recruiting
Curitiba, Paraná, Brazil
Hospital São Lucas da PUCRS ( Site 0270)Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Clínica de Neoplasias Litoral ( Site 0269)Recruiting
Itajaí, Santa Catarina, Brazil
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0251)Recruiting
Bragança Paulista, São Paulo, Brazil
Hospital de Base de São José do Rio Preto ( Site 0275)Recruiting
São José do Rio Preto, São Paulo, Brazil
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0263)Active Not Recruiting
Taubaté, São Paulo, Brazil
Hospital Paulistano ( Site 0259)Active Not Recruiting
São Paulo, Brazil
Cross Cancer Institute (Site 0281)Recruiting
Edmonton, Alberta, Canada
Trillium Health Partners - Credit Valley Hospital ( Site 0289)Recruiting
Mississauga, Ontario, Canada
The Ottawa Hospital - General Campus ( Site 0286)Recruiting
Ottawa, Ontario, Canada
Sunnybrook Research Institute ( Site 0285)Recruiting
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0276)Active Not Recruiting
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0277)Active Not Recruiting
Québec, Quebec, Canada
CIDO SpA-Oncology ( Site 0302)Recruiting
Temuco, Araucania, Chile
Clinica Universidad Catolica del Maule-Oncology ( Site 0306)Recruiting
Talca, Maule Region, Chile
FALP ( Site 0303)Recruiting
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0304)Recruiting
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0301)Recruiting
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 0305)Recruiting
Viña del Mar, Valparaiso, Chile
The Second Hospital Of Anhui Medical University ( Site 1633)Recruiting
Hefei, Anhui, China
Peking University First Hospital-Urology ( Site 1602)Recruiting
Beijing, Beijing Municipality, China
Beijing Cancer hospital-Urinary Surgery ( Site 1620)Recruiting
Beijing, Beijing Municipality, China
First Medical Center of Chinese PLA General Hospital ( Site 1601)Active Not Recruiting
Beijing, Beijing Municipality, China
Beijing Cancer Hospital ( Site 1623)Recruiting
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 1603)Recruiting
Chongqing, Chongqing Municipality, China
Southwest Hospital of Third Military Medical University ( Site 1645)Active Not Recruiting
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 1639)Recruiting
Fuzhou, Fujian, China
The first affiliated hospital of Guangzhou medical university ( Site 1637)Recruiting
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center-Urology Surgery ( Site 1638)Recruiting
Guangzhou, Guangdong, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 1632)Recruiting
Wuhan, Hubei, China
The Central Hospital of Wuhan ( Site 1635)Active Not Recruiting
Wuhan, Hubei, China
Hubei Cancer Hospital-Urinary surgery ( Site 1631)Recruiting
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 1630)Recruiting
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1615)Recruiting
Nanjing, Jiangsu, China
Nantong Tumor Hospital-Urology ( Site 1609)Recruiting
Nantong, Jiangsu, China
Wuxi People's Hospital ( Site 1612)Recruiting
Wuxi, Jiangsu, China
The Second Affiliated Hospital of Xi'an Jiaotong University-Oncology Department ( Site 1619)Recruiting
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology department ( Site 1618)Recruiting
Xi'an, Shaanxi, China
Yantai Yuhuangding Hospital ( Site 1622)Recruiting
Yantai, Shandong, China
Renji Hosp Shanghai Jiaotong U School of Med ( Site 1624)Active Not Recruiting
Shanghai, Shanghai Municipality, China
Huadong Hospital Affiliated to Fudan University-Urology ( Site 1613)Recruiting
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University-Urology Surgery ( Site 1642)Recruiting
Chengdu, Sichuan, China
Nanchong Central Hospital-urology ( Site 1647)Recruiting
Nanchong, Sichuan, China
The Second Hospital of Tianjin Medical University ( Site 1616)Recruiting
Tianjin, Tianjin Municipality, China
Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 1644)Recruiting
Ürümqi, Xinjiang, China
Yunnan Province Cancer Hospital ( Site 1643)Recruiting
Kunming, Yunnan, China
Zhejiang Provincial People's Hospital-Urology ( Site 1641)Recruiting
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing-urology ( Site 1605)Recruiting
Jiaxing, Zhejiang, China
Ningbo First Hospital-Urology ( Site 1608)Recruiting
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 1604)Recruiting
Wenzhou, Zhejiang, China
Los Cobos Medical Center ( Site 0336)Active Not Recruiting
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0326)Recruiting
Bogotá, Bogota D.C., Colombia
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0327)Recruiting
Valledupar, Cesar Department, Colombia
IMAT S.A.S ( Site 0329)Recruiting
Montería, Departamento de Córdoba, Colombia
Fundación Cardiovascular de Colombia ( Site 0328)Recruiting
Piedecuesta, Santander Department, Colombia
Fundación Valle del Lili ( Site 0330)Recruiting
Cali, Valle del Cauca Department, Colombia
Clínica Imbanaco S.A.S ( Site 0334)Active Not Recruiting
Cali, Valle del Cauca Department, Colombia
CIMCA-Hemato-Oncology ( Site 0380)Recruiting
San José, Provincia de San José, Costa Rica
Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0379)Recruiting
Santa Ana, Provincia de San José, Costa Rica
Onco Tech, S.A. ( Site 0376)Recruiting
San José, Costa Rica
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0403)Active Not Recruiting
Brno, Brno-mesto, Czechia
Krajská nemocnice Liberec-Department of Urology ( Site 0407)Active Not Recruiting
Liberec, Liberec Region, Czechia
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0401)Recruiting
Prague, Praha 5, Czechia
Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0404)Recruiting
Brno, South Moravian, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0405)Active Not Recruiting
Olomouc, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 0406)Recruiting
Prague, Czechia
East-Tallinn Central Hospital ( Site 1528)Active Not Recruiting
Tallinn, Harju, Estonia
North Estonia Medical Centre Foundation ( Site 1526)Recruiting
Tallinn, Harju, Estonia
Pärnu Haigla (Site 1550)Recruiting
Pärnu, Pärnumaa, Estonia
Tartu University Hospital-Radiotherapy and oncology ( Site 1527)Active Not Recruiting
Tartu, Tartu, Estonia
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0451)Active Not Recruiting
Strasbourg, Alsace, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0461)Active Not Recruiting
Bordeaux, Aquitaine, France
CENTRE LEON BERARD ( Site 0459)Recruiting
Lyon Cedex08, Auvergne-Rhône-Alpes, France
CHU-BREST Cavale Blanche ( Site 0456)Active Not Recruiting
Brest, Finistere, France
Ramsay Santé - Clinical La Croix Du Sud ( Site 0460)Active Not Recruiting
Quint-Fonsegrives, Haute-Garonne, France
Centre Bourgogne ( Site 0464)Active Not Recruiting
Lille, Hauts-de-France, France
Hôpital Foch ( Site 0455)Active Not Recruiting
Suresnes, Hauts-de-Seine, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0454)Active Not Recruiting
Clermont-Ferrand, Puy-de-Dome, France
Gustave Roussy ( Site 0452)Active Not Recruiting
Villejuif, Val-de-Marne, France
Sainte Catherine Institut du Cancer Avignon Provence ( Site 0458)Active Not Recruiting
Avignon, Vaucluse, France
Groupe Hospitalier Paris Saint Joseph ( Site 0465)Active Not Recruiting
Paris, France
Universitaetsklinikum Freiburg-Klinik für Urologie ( Site 0506)Active Not Recruiting
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsklinikum Heidelberg ( Site 0531)Recruiting
Heidelberg, Baden-Wurttemberg, Germany
Studienpraxis Urologie ( Site 0529)Recruiting
Nürtingen, Baden-Wurttemberg, Germany
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0521)Active Not Recruiting
Munich, Bavaria, Germany
Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0523)Active Not Recruiting
Regensburg, Bavaria, Germany
Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 0510)Completed
Marburg, Hesse, Germany
Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Urologie ( Site 0527)Recruiting
Göttingen, Lower Saxony, Germany
Marien-Krankenhaus ( Site 0515)Active Not Recruiting
Bergisch Gladbach, North Rhine-Westphalia, Germany
Universitaetsklinikum Koeln ( Site 0518)Active Not Recruiting
Cologne, North Rhine-Westphalia, Germany
Urologicum Duisburg (Site 00538)Recruiting
Duisburg, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0528)Completed
Dresden, Saxony, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)Active Not Recruiting
Berlin, Germany
Vivantes Klinikum Am Urban ( Site 0512)Recruiting
Berlin, Germany
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0553)Active Not Recruiting
Pátrai, Achaia, Greece
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0551)Recruiting
Athens, Attica, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Site 0552)Recruiting
Chaïdári, Attica, Greece
MEDI-K ( Site 0576)Recruiting
Guatemala City, Guatemala
CELAN,S.A ( Site 0579)Recruiting
Guatemala City, Guatemala
INTEGRA Cancer Institute-Oncology ( Site 0578)Recruiting
Guatemala City, Guatemala
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0577)Recruiting
Guatemala City, Guatemala
Sanatorio Nuestra Senora del Pilar ( Site 0580)Recruiting
Guatemala City, Guatemala
Hong Kong Integrated Oncology Centre ( Site 0603)Recruiting
Central, Hong Kong
Queen Mary Hospital ( Site 0602)Recruiting
Hong Kong, Hong Kong
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C ( Site 0630)Active Not Recruiting
Miskolc, Borsod-Abauj Zemplen county, Hungary
Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0636)Active Not Recruiting
Salgótarján, Nógrád megye, Hungary
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0631)Active Not Recruiting
Budapest, Pest County, Hungary
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0632)Active Not Recruiting
Debrecen, Hungary
St. Vincent's University Hospital ( Site 0652)Active Not Recruiting
Dublin, Dublin, Ireland
Tallaght University Hospital ( Site 0651)Active Not Recruiting
Dublin, Ireland
Emek Medical Center ( Site 0680)Recruiting
Afula, Israel
Rambam Health Care Campus-Oncology Division ( Site 0676)Recruiting
Haifa, Israel
Shaare Zedek Medical Center ( Site 0679)Recruiting
Jerusalem, Israel
Hadassah Medical Center ( Site 0683)Recruiting
Jerusalem, Israel
Meir Medical Center. ( Site 0682)Recruiting
Kfar Saba, Israel
Rabin Medical Center ( Site 0678)Recruiting
Petah Tikva, Israel
Sheba Medical Center ( Site 0677)Recruiting
Ramat Gan, Israel
Sourasky Medical Center ( Site 0681)Recruiting
Tel Aviv, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1454)Active Not Recruiting
Meldola, Emilia-Romagna, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1452)Recruiting
Milan, Lombardy, Italy
Ospedale Cannizzaro ( Site 1455)Recruiting
Catania, Italy
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 1456)Active Not Recruiting
Foggia, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1451)Recruiting
Milan, Italy
Azienda Ospedaliera Santa Maria Terni ( Site 1458)Recruiting
Terni, Italy
Toho University Sakura Medical Center ( Site 0730)Recruiting
Sakura, Chiba, Japan
University of Fukui Hospital ( Site 0735)Recruiting
Eiheiji-cho,Yoshida-gun, Fukui, Japan
Hospital of the University of Occupational and Environmental Health, Japan ( Site 0746)Recruiting
Kitakyushu, Fukuoka, Japan
Sapporo Medical University Hospital ( Site 0726)Recruiting
Sapporo, Hokkaido, Japan
Hokkaido University Hospital ( Site 0756)Recruiting
Sapporo, Hokkaido, Japan
Kobe University Hospital ( Site 0741)Recruiting
Kobe, Hyōgo, Japan
Kanazawa Medical University Hospital ( Site 0734)Recruiting
Mukai-awagasaki, Ishikawa-ken, Japan
Kagawa University Hospital ( Site 0744)Recruiting
Kita, Kagawa-ken, Japan
Yokohama City University Medical Center ( Site 0733)Recruiting
Yokohama, Kanagawa, Japan
Mie University Hospital ( Site 0737)Active Not Recruiting
Tsu, Mie-ken, Japan
National Hospital Organization Nagasaki Medical Center ( Site 0748)Recruiting
Ōmura, Nagasaki, Japan
Nara Medical University Hospital ( Site 0742)Recruiting
Kashihara, Nara, Japan
Nanbu Tokushukai Hospital ( Site 0755)Active Not Recruiting
Shimajiri, Okinawa, Japan
Kansai Medical University Hospital ( Site 0739)Recruiting
Hirakata, Osaka, Japan
Bell Land General Hospital ( Site 0740)Active Not Recruiting
Sakai, Osaka, Japan
The University of Osaka Hospital ( Site 0738)Recruiting
Suita, Osaka, Japan
Saga-Ken Medical Centre Koseikan ( Site 0747)Recruiting
Saga, Saga-ken, Japan
Nihon University Itabashi Hospital ( Site 0732)Completed
Itabashiku, Tokyo, Japan
The Jikei University Hospital ( Site 0731)Recruiting
Minato, Tokyo, Japan
Akita University Hospital ( Site 0728)Recruiting
Akita, Japan
Kyushu University Hospital ( Site 0745)Active Not Recruiting
Fukuoka, Japan
Fukushima Medical University Hospital ( Site 0758)Recruiting
Fukushima, Japan
Gifu University Hospital ( Site 0736)Recruiting
Gifu, Japan
Hiroshima University Hospital ( Site 0743)Active Not Recruiting
Hiroshima, Japan
Kagoshima University Hospital ( Site 0754)Active Not Recruiting
Kagoshima, Japan
National Hospital Organization Kumamoto Medical Center ( Site 0749)Recruiting
Kumamoto, Japan
Miyazaki Prefectural Miyazaki Hospital ( Site 0752)Recruiting
Miyazaki, Japan
University of Miyazaki Hospital ( Site 0751)Recruiting
Miyazaki, Japan
Nagano Municipal Hospital ( Site 0757)Recruiting
Nagano, Japan
National Hospital Organization Oita Medical Center ( Site 0750)Completed
Ōita, Japan
Liepaja Regional Hospital ( Site 1553)Active Not Recruiting
Liepāja, Latvia
Pauls Stradins Clinical Univeristy Hospital-Urological department ( Site 1551)Recruiting
Riga, Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 1576)Recruiting
Kaunas, Kaunas County, Lithuania
National Cancer Institute ( Site 1577)Recruiting
Vilnius, Vilniaus Miestas, Lithuania
Hospital Sultan Ismail ( Site 0905)Recruiting
Johor Bahru, Johor, Malaysia
University Malaya Medical Centre ( Site 0902)Recruiting
Lembah Pantai, Kuala Lumpur, Malaysia
National Cancer Institute ( Site 0904)Completed
Putrajaya, Putrajaya, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 0901)Recruiting
Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 0903)Recruiting
Kuala Lumpur, Malaysia
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0928)Active Not Recruiting
Guadalajara, Jalisco, Mexico
Health Pharma Professional Research S.A. de C.V: ( Site 0929)Active Not Recruiting
Mexico City, Mexico City, Mexico
Higiea Oncologia ( Site 0938)Active Not Recruiting
Mexico City, Mexico City, Mexico
Quemex Medical and Research ( Site 0937)Active Not Recruiting
Tlalpan, Mexico City, Mexico
Filios Alta Medicina ( Site 0931)Active Not Recruiting
Monterrey, Nuevo León, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0932)Active Not Recruiting
Monterrey, Nuevo León, Mexico
Eukarya Pharmasite S.C. ( Site 0939)Active Not Recruiting
Monterrey, Nuevo León, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0934)Active Not Recruiting
Oaxaca City, Oaxaca, Mexico
Dunedin Hospital ( Site 1032)Completed
Dunedin, Otago, New Zealand
Auckland City Hospital ( Site 1033)Recruiting
Auckland, New Zealand
Aliada-Oncologìa ( Site 1055)Recruiting
Lima, Peru
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1052)Recruiting
Lima, Peru
Oncosalud-Clinical Research ( Site 1057)Recruiting
Lima, Peru
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1054)Active Not Recruiting
Lima, Peru
Hospital de Cascais Doutor José de Almeida ( Site 1158)Active Not Recruiting
Alcabideche, Lisbon District, Portugal
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1156)Active Not Recruiting
Vila Nova de Gaia, Porto District, Portugal
Unidade Local de Saude de Braga - Hospital de Braga ( Site 1151)Active Not Recruiting
Braga, Portugal
Hospital CUF - Tejo ( Site 1157)Active Not Recruiting
Lisbon, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1153)Active Not Recruiting
Lisbon, Portugal
Unidade Local de Saude de Santo António - Hospital Santo António ( Site 1152)Active Not Recruiting
Porto, Portugal
Advance Urology and Laparoscopic Center ( Site 1178)Completed
Ponce, Puerto Rico
Ad-Vance Medical Research-Research ( Site 1177)Recruiting
Ponce, Puerto Rico
Pan American Center for Oncology Trials - Ciudadela ( Site 1176)Recruiting
San Juan, Puerto Rico
Spitalul Universitar de Urgență Elias ( Site 1504)Recruiting
Bucharest, Bucharest, Romania
Cardiomed SRL Cluj-Napoca ( Site 1503)Active Not Recruiting
Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL ( Site 1502)Active Not Recruiting
Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie" ( Site 1501)Active Not Recruiting
Craiova, Dolj, Romania
National University Hospital ( Site 1201)Recruiting
Singapore, Central Singapore, Singapore
National Cancer Centre Singapore ( Site 1202)Recruiting
Singapore, Central Singapore, Singapore
Singapore General Hospital ( Site 1204)Recruiting
Singapore, Central Singapore, Singapore
Tan Tock Seng Hospital-Medical Oncology ( Site 1203)Recruiting
Singapore, Central Singapore, Singapore
UROEXAM ( Site 1479)Active Not Recruiting
Nitra, Nitra Region, Slovakia
Privatna Urologicka Ambulancia ( Site 1478)Active Not Recruiting
Trenčín, Trenčín Region, Slovakia
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1230)Recruiting
Port Elizabeth, Eastern Cape, South Africa
Wits Clinical Research ( Site 1234)Active Not Recruiting
Johannesburg, Gauteng, South Africa
Wilgers Oncology Centre ( Site 1232)Active Not Recruiting
Pretoria, Gauteng, South Africa
Curo Oncology. ( Site 1237)Recruiting
Pretoria, Gauteng, South Africa
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1236)Active Not Recruiting
Pretoria, Gauteng, South Africa
Cape Town Oncology Trials ( Site 1233)Completed
Cape Town, Western Cape, South Africa
National Cancer Center-Center for Urologic Cancer ( Site 1254)Recruiting
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital-Urology ( Site 1253)Recruiting
Seongnam, Kyonggi-do, South Korea
Kyungpook National University Chilgok Hospital-Urology ( Site 1252)Recruiting
Buk-gu, Kyongsangbuk-do, South Korea
Pusan National University Yangsan Hospital ( Site 1256)Recruiting
Pusan, Kyongsangnam-do, South Korea
Seoul National University Hospital-Urology ( Site 1251)Recruiting
Seoul, South Korea
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1255)Recruiting
Seoul, South Korea
Hospital Universitari Parc Tauli-oncologia ( Site 1282)Recruiting
Sabadell, Barcelona, Spain
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1284)Recruiting
Barcelona, Catalonia, Spain
Institut Català d'Oncologia (ICO) - Girona ( Site 1285)Recruiting
Girona, Gerona, Spain
Complexo Hospitalario Universitario A Coruna ( Site 1288)Recruiting
A Coruña, La Coruna, Spain
Hospital Insular de Gran Canaria-Oncology ( Site 1280)Recruiting
Las Palmas de Gran Canaria, Las Palmas, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1283)Recruiting
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario de Burgos-Oncología ( Site 1281)Recruiting
Burgos, Spain
Hospital Quirón Málaga ( Site 1286)Recruiting
Málaga, Spain
Karolinska Universitetssjukhuset Solna ( Site 1302)Active Not Recruiting
Stockholm, Stockholm County, Sweden
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1301)Active Not Recruiting
Uppsala, Uppsala County, Sweden
Chi Mei Medical Center ( Site 1336)Recruiting
Tainan, Tainan, Taiwan
Kaohsiung Veterans General Hospital ( Site 1337)Recruiting
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1331)Recruiting
Kaohsiung City, Taiwan
China Medical University Hospital-Department of Urology ( Site 1335)Recruiting
Taichung, Taiwan
Taichung Veterans General Hospital ( Site 1338)Recruiting
Taichung, Taiwan
Taipei Veterans General Hospital ( Site 1332)Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1334)Recruiting
Taoyuan District, Taiwan
Chulalongkorn University ( Site 1355)Recruiting
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 1356)Recruiting
Bangkok, Bangkok, Thailand
Faculty of Medicine - Khon Kaen University ( Site 1351)Active Not Recruiting
Muang, Changwat Khon Kaen, Thailand
Songklanagarind hospital ( Site 1352)Recruiting
Hat Yai, Changwat Songkhla, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 1353)Recruiting
Muang, Chiang Mai, Thailand
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1379)Recruiting
Adana, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1376)Recruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1377)Recruiting
Ankara, Turkey (Türkiye)
Koc Universitesi Hastanesi ( Site 1384)Recruiting
Istanbul, Turkey (Türkiye)
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1381)Recruiting
Istanbul, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1383)Recruiting
Istanbul, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1378)Recruiting
Istanbul, Turkey (Türkiye)
Ege Universitesi Hastanesi-Medical Oncology ( Site 1380)Recruiting
Izmir, Turkey (Türkiye)
Samsun Medical Park Hastanesi-medical oncology ( Site 1382)Recruiting
Samsun, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1426)Recruiting
Cambridge, Cambridgeshire, United Kingdom
Royal Derby Hospital ( Site 1431)Recruiting
Derby, Derbyshire, United Kingdom
Torbay Hospital ( Site 1429)Recruiting
Torquay, Devon, United Kingdom
Mount Vernon Cancer Centre ( Site 1440)Recruiting
Northwood, England, United Kingdom
The Royal Cornwall Hospital ( Site 1430)Recruiting
Truro, England, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1428)Recruiting
Glasgow, Glasgow City, United Kingdom
Charing Cross Hospital-Oncology Research ( Site 1434)Recruiting
London, Hammersmith and Fulham, United Kingdom
University College London Hospital ( Site 1437)Active Not Recruiting
London, London, City of, United Kingdom
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435)Active Not Recruiting
London, London, City of, United Kingdom
St. George's Hospital-Oncology ( Site 1441)Completed
London, London, City of, United Kingdom
GenesisCare - Oxford ( Site 1442)Active Not Recruiting
Oxford, Oxfordshire, United Kingdom
GenesisCare - Windsor ( Site 1443)Active Not Recruiting
Windsor, Windsor And Maidenhead, United Kingdom
The Christie NHS Foundation Trust ( Site 1436)Recruiting
Manchester, United Kingdom
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) · TrialPath