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

May 4, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-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-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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1310

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman-Oncology ( Site 0207)
        • Contact:
          • Study Coordinator
          • Phone Number: 01148277000
      • Mendoza, Argentina, M5500AYB
        • Active, not recruiting
        • Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0204)
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
        • Recruiting
        • Hospital Británico de Buenos Aires-Oncology ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: 1143096839
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Recruiting
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: 02234963224
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, 1426ANZ
        • Recruiting
        • Instituto Alexander Fleming-Alexander Fleming ( Site 0206)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Buenos Aires, Buenos Aires F.D., Argentina, C1419AHN
        • Recruiting
        • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DVC
        • Recruiting
        • Sanatorio Parque ( Site 0208)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • Australia
    • New South Wales
      • Dubbo, New South Wales, Australia, 2830
        • Recruiting
        • Dubbo Hospital ( Site 0235)
        • Contact:
          • Study Coordinator
          • Phone Number: 0268096200
      • Macquarie University, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University-MQ Health Clinical Trials Unit ( Site 0234)
        • Contact:
          • Study Coordinator
          • Phone Number: 0298122979
      • Westmead, New South Wales, Australia, 2145
        • Active, not recruiting
        • Westmead Hospital ( Site 0232)
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital-Cancer Care Serices ( Site 0237)
        • Contact:
          • Study Coordinator
          • Phone Number: +6173176 9289
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Active, not recruiting
        • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230)
  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Recruiting
        • Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0280)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276)
        • Contact:
          • Study Coordinator
          • Phone Number: +4373276774724
      • Wels, Upper Austria, Austria, 4600
        • Recruiting
        • Klinikum Wels-Grieskirchen GmbH ( Site 0279)
        • Contact:
          • Study Coordinator
          • Phone Number: +4372424152328
  • Brazil
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29041-295
        • Recruiting
        • Hospital Santa Rita de Cassia-Centro de Pesquisa Clínica ( Site 0320)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40415-006
        • Active, not recruiting
        • Obras Sociais Irma Dulce ( Site 0302)
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-934
        • Recruiting
        • Hospital Felicio Rocho ( Site 0317)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Belo Horizonte, Minas Gerais, Brazil, 30380-472
        • Active, not recruiting
        • Hospital Mario Penna ( Site 0309)
    • Paraná
      • Curitiba, Paraná, Brazil, 80440-220
        • Active, not recruiting
        • Hospital Universitário Evangélico Mackenzie-Centro de Oncologia Mackenzie ( Site 0314)
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil, 88301-220
        • Recruiting
        • Clínica de Neoplasias Litoral ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: +5547984046243
    • São Paulo
      • Bragança Paulista, São Paulo, Brazil, 12916-542
        • Active, not recruiting
        • Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0308)
      • São Paulo, São Paulo, Brazil, 01509-010
        • Active, not recruiting
        • A. C. Camargo Cancer Center ( Site 0310)
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute ( Site 0332)
        • Contact:
          • Study Coordinator
          • Phone Number: 7804328762
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0336)
        • Contact:
          • Study Coordinator
          • Phone Number: 613-737-7700
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute ( Site 0331)
        • Contact:
          • Study Coordinator
          • Phone Number: 647-533-1023
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre ( Site 0330)
        • Contact:
          • Study Coordinator
          • Phone Number: (416) 946-4501
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Recruiting
        • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0328)
        • Contact:
          • Study Coordinator
          • Phone Number: 4504665000 ext 3226
      • Montreal, Quebec, Canada, H2X 3E4
        • Active, not recruiting
        • Centre Hospitalier de l'Université de Montréal ( Site 0326)
      • Québec, Quebec, Canada, G1J 1Z4
        • Recruiting
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0327)
        • Contact:
          • Study Coordinator
          • Phone Number: 418 525-4444
      • Sherbrooke, Quebec, Canada, J1H 5H4
        • Active, not recruiting
        • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0329)
  • Chile
      • Antofagasta, Chile, 1240000
        • Active, not recruiting
        • Bradford Hill Norte ( Site 0357)
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chile, 1720430
        • Active, not recruiting
        • IC La Serena Research ( Site 0356)
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5110683
        • Active, not recruiting
        • Clinical Research Chile SpA ( Site 0358)
    • Maule Region
      • Talca, Maule Region, Chile, 3465584
        • Recruiting
        • Clinica Universidad Catolica del Maule-Oncology ( Site 0355)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Active, not recruiting
        • FALP ( Site 0353)
      • Santiago, Region M. de Santiago, Chile, 8330024
        • Recruiting
        • Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 0351)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Recruiting
        • Second Affiliated hospital of Anhui Medical University-Urology ( Site 0408)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 02782201756
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital-Urology ( Site 0390)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 (010) 64008229
      • Beijing, Beijing Municipality, China, 100050
        • Recruiting
        • Beijing Friendship Hospital Affiliate of Capital University ( Site 0396)
        • Contact:
          • Study Coordinator
          • Phone Number: +86(010)63138375
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer hospital-Urinary Surgery ( Site 0395)
        • Contact:
          • Study Coordinator
          • Phone Number: 86 010 8812 1122
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital ( Site 0416)
        • Contact:
          • Study Coordinator
          • Phone Number: 02365075629
      • Chongqing, Chongqing Municipality, China, 400038
        • Recruiting
        • Southwest Hospital of Third Military Medical University ( Site 0420)
        • Contact:
          • Study Coordinator
          • Phone Number: 023 68765878
      • Chongqing, Chongqing Municipality, China, 404100
        • Recruiting
        • Chongqing Three Gorges Central Hospital's ( Site 0426)
        • Contact:
          • Study Coordinator
          • Phone Number: 023 58103150
      • Chongqing, Chongqing Municipality, China, 400010
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University ( Site 0427)
        • Contact:
          • Study Coordinator
          • Phone Number: 023 89012012
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0414)
        • Contact:
          • Study Coordinator
          • Phone Number: +86059187983333
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated hospital of Xiamen University-Urology ( Site 0415)
        • Contact:
          • Study Coordinator
          • Phone Number: 0592-2132222
    • Guangdong
      • Guangzhou, Guangdong, China, 511400
        • Recruiting
        • Sun Yat-sen University Cancer Center-Internal medicine ( Site 0413)
        • Contact:
          • Study Coordinator
          • Phone Number: +8602087343533
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University ( Site 0412)
        • Contact:
          • Study Coordinator
          • Phone Number: (020) 83062114
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital-Urinary surgery ( Site 0406)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613907110640
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 0407)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-83665555
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 0405)
        • Contact:
          • Study Coordinator
          • Phone Number: 073189762270
    • Jiangsu
      • Huaian, Jiangsu, China, 223300
        • Recruiting
        • First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0436)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 0377)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Wuxi, Jiangsu, China, 214122
        • Recruiting
        • Affiliated hospital of Jiangnan university ( Site 0434)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Cancer Hospital ( Site 0386)
        • Contact:
          • Study Coordinator
          • Phone Number: 86079188317256
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0393)
        • Contact:
          • Study Coordinator
          • Phone Number: 029-85323112
      • Xi'an, Shaanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 0394)
        • Contact:
          • Study Coordinator
          • Phone Number: 029-87679000
    • Shandong
      • Yantai, Shandong, China, 264099
        • Recruiting
        • Yantai Yuhuangding Hospital ( Site 0397)
        • Contact:
          • Study Coordinator
          • Phone Number: 86 0535 6691999
    • Shangai
      • Shanghai, Shangai, China, 200032
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Recruiting
        • Fudan University Shanghai Cancer Center-Urology department ( Site 0376)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-38196379
      • Shanghai, Shanghai Municipality, China, 200041
        • Recruiting
        • Huadong Hospital Affiliated to Fudan University-Urology ( Site 0388)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Sichuan
      • Chengdu, Sichuan, China, 500643
        • Recruiting
        • The Third People's Hospital of Chengdu (CDTPH) ( Site 0428)
        • Contact:
          • Study Coordinator
          • Phone Number: 67566947
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University-Urology Surgery ( Site 0417)
        • Contact:
          • Study Coordinator
          • Phone Number: +86028-85422114
      • Nanchong, Sichuan, China, 500643
        • Recruiting
        • Nanchong Central Hospital-urology ( Site 0422)
        • Contact:
          • Study Coordinator
          • Phone Number: 08172606822
      • Suining, Sichuan, China, 629000
        • Recruiting
        • Suining Central Hospital ( Site 0437)
        • Contact:
          • Study Coordinator
          • Phone Number: 08252292093
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital ( Site 0392)
        • Contact:
          • Study Coordinator
          • Phone Number: +862223340123
      • Tianjin, Tianjin Municipality, China, 300211
        • Recruiting
        • The Second Hospital of Tianjin Medical University ( Site 0391)
        • Contact:
          • Study Coordinator
          • Phone Number: +8602288326748
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Recruiting
        • Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 0419)
        • Contact:
          • Study Coordinator
          • Phone Number: 86 09917819156
    • Yunnan
      • Kunming, Yunnan, China, 650033
        • Recruiting
        • The Second Affiliated Hospital Of Kunming Medical University ( Site 0429)
        • Contact:
          • Study Coordinator
          • Phone Number: 087165351281
      • Kunming, Yunnan, China, 650107
        • Recruiting
        • Yunnan Province Cancer Hospital ( Site 0418)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital-Urology ( Site 0378)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital ( Site 0435)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-88122261
      • Jiaxing, Zhejiang, China, 314001
        • Recruiting
        • The First Hospital of Jiaxing-urology ( Site 0380)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University ( Site 0383)
        • Contact:
          • Study Coordinator
          • Phone Number: 86057487085588
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0379)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 111321
        • Recruiting
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: 6017058333
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Recruiting
        • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3158505190
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Recruiting
        • IMAT S.A.S ( Site 0504)
        • Contact:
          • Study Coordinator
          • Phone Number: +573135342052
    • Santander Department
      • Piedecuesta, Santander Department, Colombia, 681017
        • Recruiting
        • Fundación Cardiovascular de Colombia ( Site 0503)
        • Contact:
          • Study Coordinator
          • Phone Number: +573203400438
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760042
        • Active, not recruiting
        • Clínica Imbanaco S.A.S ( Site 0509)
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 0505)
        • Contact:
          • Study Coordinator
          • Phone Number: +573133288646
  • Czechia
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 656 53
        • Recruiting
        • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553)
        • Contact:
          • Study Coordinator
          • Phone Number: +420 543 136 216
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • Recruiting
        • Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554)
        • Contact:
          • Study Coordinator
          • Phone Number: +420597372264
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • Recruiting
        • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555)
        • Contact:
          • Study Coordinator
          • Phone Number: +420 588 444 699
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Active, not recruiting
        • Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0551)
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Recruiting
        • Rigshospitalet ( Site 0576)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 35453545
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Active, not recruiting
        • Odense Universitetshospital-Department of oncology ( Site 0579)
      • Vejle, Region Syddanmark, Denmark, 7100
        • Recruiting
        • Vejle Sygehus ( Site 0578)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 79405000
  • Finland
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70210
        • Recruiting
        • Kuopion Yliopistollinen Sairaala ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: 35817173311
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampereen yliopistollinen sairaala ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: 358331166811
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Recruiting
        • Turku University Hospital-Department of Oncology ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: 35823130729
  • France
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou ( Site 0628)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Ain
      • Lille, Ain, France, 59020
        • Recruiting
        • Centre Oscar Lambret (Site 0634)
        • Contact:
    • Alsace
      • Strasbourg, Alsace, France, 67200
        • Recruiting
        • Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0627)
        • Contact:
          • Study Coordinator
          • Phone Number: +33368767207
    • Gard
      • Nîmes, Gard, France, 30029
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 0630)
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35042
        • Recruiting
        • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0632)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63003
        • Recruiting
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0629)
        • Contact:
          • Study Coordinator
          • Phone Number: +33473278005
    • Pyrenees-Atlantiques
      • Bayonne, Pyrenees-Atlantiques, France, 64109
        • Recruiting
        • Centre Hospitalier de la Côte Basque ( Site 0633)
        • Contact:
          • Study Coordinator
          • Phone Number: 33559443535
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Recruiting
        • Gustave Roussy ( Site 0626)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049 30 450615297
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0705)
        • Contact:
          • Study Coordinator
          • Phone Number: +4915222815585
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Active, not recruiting
        • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0696)
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
        • Recruiting
        • HELIOS Kliniken Schwerin ( Site 0694)
        • Contact:
          • Study Coordinator
          • Phone Number: +493855202120
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Recruiting
        • Universitätsklinikum Bonn-Klinik und Poliklinik für Urologie und Kinderurologie ( Site 0680)
        • Contact:
          • Study Coordinator
          • Phone Number: +4922828714249
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster - Albert Schweitzer Campus-Klinik für Urologie ( Site 0678)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049251-8344658
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein-Klinik für Urologie ( Site 0691)
        • Contact:
          • Study Coordinator
          • Phone Number: +4945150043699
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Recruiting
        • Universitätsklinikum Jena-Klinik und Poliklinik für Urologie ( Site 0682)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 3641 9 32 9947
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 0727)
        • Contact:
          • Study Coordinator
          • Phone Number: +85222553838
      • Shatin, Hong Kong
        • Recruiting
        • Prince of Wales Hospital ( Site 0730)
        • Contact:
          • Study Coordinator
          • Phone Number: +85235052211
  • Hungary
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758)
        • Contact:
          • Study Coordinator
          • Phone Number: +3652411717
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Recruiting
        • Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752)
        • Contact:
          • Study Coordinator
          • Phone Number: +3676516719
    • Nógrád megye
      • Salgótarján, Nógrád megye, Hungary, 3100
        • Recruiting
        • Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0761)
        • Contact:
          • Study Coordinator
          • Phone Number: +3632522000
    • Pest County
      • Budapest, Pest County, Hungary, 1122
        • Recruiting
        • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756)
        • Contact:
          • Study Coordinator
          • Phone Number: +36122486001171
  • Ireland
      • Dublin, Ireland, D24 NR0A
        • Recruiting
        • Tallaght University Hospital ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Dublin
      • Dublin, Dublin, Ireland, D04 T6F4
        • Recruiting
        • St. Vincent's University Hospital ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • Israel
      • Afula, Israel, 1834111
        • Recruiting
        • Emek Medical Center ( Site 0830)
        • Contact:
          • Study Coordinator
          • Phone Number: 0546708579
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Oncology Division ( Site 0826)
        • Contact:
          • Study Coordinator
          • Phone Number: 04-7776234
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 0833)
        • Contact:
          • Study Coordinator
          • Phone Number: 02-6777111
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center. ( Site 0832)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 0828)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-50-3745684
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 0827)
        • Contact:
          • Study Coordinator
          • Phone Number: : +972-35302191
  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele-Oncologia Medica ( Site 0876)
        • Contact:
          • Study Coordinator
          • Phone Number: +390226435668
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 0879)
        • Contact:
          • Study Coordinator
          • Phone Number: +390543739100
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390223903033
  • Japan
      • Akita, Japan, 010-8543
        • Recruiting
        • Akita University Hospital ( Site 0904)
        • Contact:
          • Study Coordinator
          • Phone Number: +81188341111
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital ( Site 0919)
        • Contact:
          • Study Coordinator
          • Phone Number: +81926411151
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital ( Site 0933)
        • Contact:
          • Study Coordinator
          • Phone Number: +81245471111
      • Gifu, Japan, 501-1112
        • Recruiting
        • Gifu University Hospital ( Site 0910)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-58-230-6000
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital ( Site 0916)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-82-257-5555
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University Hospital ( Site 0929)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-99-275-5111
      • Kumamoto, Japan, 860-0008
        • Recruiting
        • National Hospital Organization Kumamoto Medical Center ( Site 0924)
        • Contact:
          • Study Coordinator
          • Phone Number: +81963536501
      • Miyazaki, Japan, 880-8510
        • Recruiting
        • Miyazaki Prefectural Miyazaki Hospital ( Site 0927)
        • Contact:
          • Study Coordinator
          • Phone Number: +81985244181
      • Miyazaki, Japan, 889-1692
        • Recruiting
        • University of Miyazaki Hospital ( Site 0926)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-98-585-1510
      • Nagano, Japan, 381-8551
        • Recruiting
        • Nagano Municipal Hospital ( Site 0932)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-26-295-1199
      • Ōita, Japan, 870-0263
        • Active, not recruiting
        • National Hospital Organization Oita Medical Center ( Site 0925)
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Recruiting
        • Toho University Sakura Medical Center ( Site 0906)
        • Contact:
          • Study Coordinator
          • Phone Number: +81434628811
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Recruiting
        • Ehime University Hospital ( Site 0918)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-964-5111
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Active, not recruiting
        • Hospital of the University of Occupational and Environmental Health, Japan ( Site 0921)
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital ( Site 0920)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-942-35-3311
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8510
        • Recruiting
        • Asahikawa Medical University Hospital ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-166-65-2111
      • Sapporo, Hokkaido, Japan, 060-8543
        • Recruiting
        • Sapporo Medical University Hospital ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-611-2111
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital ( Site 0931)
        • Contact:
          • Study Coordinator
          • Phone Number: +81117161161
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital ( Site 0914)
        • Contact:
          • Study Coordinator
          • Phone Number: +81783825111
    • Ishikawa-ken
      • Mukai-awagasaki, Ishikawa-ken, Japan, 920-0265
        • Recruiting
        • Kanazawa Medical University Hospital ( Site 0909)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-76-286-3511
    • Kagawa-ken
      • Kita, Kagawa-ken, Japan, 761-0701
        • Recruiting
        • Kagawa University Hospital ( Site 0917)
        • Contact:
          • Study Coordinator
          • Phone Number: +81878985111
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center ( Site 0908)
        • Contact:
          • Study Coordinator
          • Phone Number: +81452615656
    • Nagasaki
      • Ōmura, Nagasaki, Japan, 856-8562
        • Recruiting
        • National Hospital Organization Nagasaki Medical Center ( Site 0923)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-957-52-3121
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Active, not recruiting
        • Nara Medical University Hospital ( Site 0915)
    • Okinawa
      • Shimajiri, Okinawa, Japan, 901-0417
        • Recruiting
        • Nanbu Tokushukai Hospital ( Site 0930)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-98-998-3221
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 0912)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-804-0101
      • Sakai, Osaka, Japan, 599-8247
        • Recruiting
        • Bell Land General Hospital ( Site 0913)
        • Contact:
          • Study Coordinator
          • Phone Number: +81722342001
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • The University of Osaka Hospital ( Site 0911)
        • Contact:
          • Study Coordinator
          • Phone Number: +81668795111
    • Saga-ken
      • Saga, Saga-ken, Japan, 840-8571
        • Active, not recruiting
        • Saga-Ken Medical Centre Koseikan ( Site 0922)
    • Tokyo
      • Minato, Tokyo, Japan, 105-8471
        • Active, not recruiting
        • The Jikei University Hospital ( Site 0907)
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078)
        • Contact:
          • Study Coordinator
          • Phone Number: +60326155810
    • Johor
      • Johor Bahru, Johor, Malaysia, 81100
        • Recruiting
        • Hospital Sultan Ismail ( Site 1081)
        • Contact:
          • Study Coordinator
          • Phone Number: +6073565155
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Active, not recruiting
        • University Malaya Medical Centre ( Site 1077)
    • Putrajaya
      • Putrajaya, Putrajaya, Malaysia, 62250
        • Recruiting
        • National Cancer Institute ( Site 1079)
        • Contact:
          • Study Coordinator
          • Phone Number: +60388925418
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Sarawak General Hospital-Radiotherapy Unit ( Site 1076)
        • Contact:
          • Study Coordinator
          • Phone Number: +6082276820
  • Mexico
      • Oaxaca City, Mexico, 68020
        • Active, not recruiting
        • Centro de Investigacion Clinica de Oaxaca ( Site 1109)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44630
        • Active, not recruiting
        • CIO - Centro de Inmuno-Oncología de Occidente ( Site 1103)
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14308
        • Active, not recruiting
        • Quemex Medical and Research ( Site 1112)
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Active, not recruiting
        • Filios Alta Medicina ( Site 1106)
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Active, not recruiting
        • Medical Care and Research SA de CV ( Site 1108)
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Radboudumc-Medical Oncology ( Site 1152)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 (0)24 361 0353
    • Limburg
      • Sittard-Geleen, Limburg, Netherlands, 6162 BG
        • Active, not recruiting
        • Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1163)
      • Venlo, Limburg, Netherlands, 5912 BL
        • Active, not recruiting
        • VieCuri Medisch Centrum ( Site 1173)
    • North Brabant
      • Tilburg, North Brabant, Netherlands, 5022 GC
        • Recruiting
        • ETZ Elisabeth-Internal Medicine ( Site 1160)
        • Contact:
          • Study Coordinator
          • Phone Number: +3113221 0210
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HV
        • Active, not recruiting
        • Amsterdam UMC, locatie VUmc ( Site 1156)
      • Amsterdam, North Holland, Netherlands, 1066 CX
        • Recruiting
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1153)
        • Contact:
          • Study Coordinator
          • Phone Number: +31205122569
      • Hoofddorp, North Holland, Netherlands, 2134 TM
        • Recruiting
        • Spaarne Gasthuis - Hoofddorp-Oncology ( Site 1170)
        • Contact:
          • Study Coordinator
          • Phone Number: +31232245802
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
        • Recruiting
        • Medische Centrum Leeuwarden ( Site 1172)
        • Contact:
          • Study Coordinator
          • Phone Number: +31582866660
    • South Holland
      • Schiedam, South Holland, Netherlands, 3118 JH
        • Recruiting
        • Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151)
        • Contact:
          • Study Coordinator
          • Phone Number: 003110- 4617590
      • The Hague, South Holland, Netherlands, 2545 AA
        • Recruiting
        • Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164)
        • Contact:
          • Study Coordinator
          • Phone Number: +31702102143
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3813TZ
        • Recruiting
        • Meander Medisch Centrum ( Site 1157)
        • Contact:
          • Study Coordinator
          • Phone Number: +003133 - 850 1189
  • New Zealand
    • Bay of Plenty
      • Tauranga, Bay of Plenty, New Zealand, 3112
        • Recruiting
        • Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +64277033845
    • Otago
      • Dunedin, Otago, New Zealand, 9016
        • Recruiting
        • Dunedin Hospital-Southern Blood and Cancers Service ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +64 3 470 9692
  • Norway
    • Akershus
      • Lørenskog, Akershus, Norway, 1474
        • Recruiting
        • Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227)
        • Contact:
          • Study Coordinator
          • Phone Number: +4767963800
    • Sor-Trondelag
      • Trondheim, Sor-Trondelag, Norway, 7030
        • Active, not recruiting
        • St. Olavs Hospital-Kreftklinikken ( Site 1231)
    • Østfold fylke
      • Sarpsborg, Østfold fylke, Norway, 1714
        • Active, not recruiting
        • Sykehuset Østfold Kalnes ( Site 1228)
  • Peru
      • Lima, Peru, 15038
        • Recruiting
        • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1256)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Lima, Peru, 15036
        • Active, not recruiting
        • Aliada-Oncologìa ( Site 1257)
      • Lima, Peru, 15036
        • Active, not recruiting
        • IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1254)
      • Lima, Peru, 15036
        • Active, not recruiting
        • Oncosalud-Clinical Research ( Site 1260)
    • Departamento de Junín
      • Concepción, Departamento de Junín, Peru, 12125
        • Recruiting
        • Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 1258)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • La Libertad
      • Trujillo, La Libertad, Peru, 13009
        • Recruiting
        • Clínica Sánchez Ferrer ( Site 1261)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +48523743589
      • Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland, 86-300
        • Recruiting
        • Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1316)
        • Contact:
          • Study Coordinator
          • Phone Number: +48566414444
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Active, not recruiting
        • Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 1304)
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • Recruiting
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310)
        • Contact:
          • Study Coordinator
          • Phone Number: +48256403301
    • West Pomeranian Voivodeship
      • Koszalin, West Pomeranian Voivodeship, Poland, 75-581
        • Recruiting
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +48943488930
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-730
        • Recruiting
        • Zachodniopomorskie Centrum Onkologii ( Site 1311)
        • Contact:
          • Study Coordinator
          • Phone Number: +48914251502
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Recruiting
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1318)
        • Contact:
          • Study Coordinator
          • Phone Number: +48413674811
  • Puerto Rico
      • Hato Rey, Puerto Rico, 00917
        • Active, not recruiting
        • Puerto Rico Medical Research Center LLC ( Site 1354)
      • Ponce, Puerto Rico, 00717
        • Recruiting
        • Ad-Vance Medical Research-Research ( Site 1353)
        • Contact:
          • Study Coordinator
          • Phone Number: 787-651-6697
      • San Juan, Puerto Rico, 00909
        • Active, not recruiting
        • Pan American Center for Oncology Trials - Ciudadela ( Site 1351)
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore ( Site 1377)
        • Contact:
          • Study Coordinator
          • Phone Number: +65-64368000
      • Singapore, Central Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital-Medical Oncology ( Site 1378)
        • Contact:
          • Study Coordinator
          • Phone Number: +65-62566011
      • Singapore, Central Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital ( Site 1376)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • South Korea
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 1405)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234101767
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital-Oncology ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220721672
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +82222288138
    • Seoul
      • Songpagu, Seoul, South Korea, 05505
        • Active, not recruiting
        • Asan Medical Center-Oncology ( Site 1402)
  • Spain
      • Lugo, Spain, 27003
        • Recruiting
        • Hospital Lucus Augusti-Oncology ( Site 1432)
        • Contact:
          • Study Coordinator
          • Phone Number: +34982296459
      • Seville, Spain, 41013
        • Recruiting
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428)
        • Contact:
          • Study Coordinator
          • Phone Number: 34955013068
    • Cadiz
      • Jerez de la Frontera, Cadiz, Spain, 11407
        • Recruiting
        • Hospital Jerez de la Frontera ( Site 1427)
        • Contact:
          • Study Coordinator
          • Phone Number: +34661753582
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431)
        • Contact:
          • Study Coordinator
          • Phone Number: 34913368263
      • Madrid, Madrid, Comunidad de, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433)
        • Contact:
          • Study Coordinator
          • Phone Number: 608464547
    • Orense
      • Ourense, Orense, Spain, 32005
        • Recruiting
        • Complexo Hospitalario Universitario de Ourense ( Site 1426)
        • Contact:
          • Study Coordinator
          • Phone Number: +34988385471
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Recruiting
        • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 961114229
  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 64
        • Active, not recruiting
        • Karolinska Universitetssjukhuset Solna ( Site 1478)
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 751 85
        • Recruiting
        • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477)
        • Contact:
          • Study Coordinator
          • Phone Number: 0046186110000
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset ( Site 1479)
        • Contact:
          • Study Coordinator
          • Phone Number: 0046313421000
  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital-Department of Urology ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-4-2205-2121
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital-Urology ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-6-2353535
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-2-28712121
      • Taipei, Taiwan, 10002
        • Active, not recruiting
        • National Taiwan University Hospital-Urology ( Site 1506)
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-3-3281200
  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 1531)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Bangkok, Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University ( Site 1530)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Changwat Khon Kaen
      • Muang, Changwat Khon Kaen, Thailand, 40002
        • Recruiting
        • Faculty of Medicine - Khon Kaen University ( Site 1526)
        • Contact:
          • Study Coordinator
          • Phone Number: +66 43 366568-9
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Recruiting
        • Songklanagarind hospital ( Site 1527)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01250
        • Recruiting
        • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1554)
        • Contact:
          • Study Coordinator
          • Phone Number: +903223444444
      • Ankara, Turkey (Türkiye), 06010
        • Recruiting
        • Gulhane Egitim Arastirma Hastanesi ( Site 1558)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Ankara, Turkey (Türkiye), 06520
        • Recruiting
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 1557)
        • Contact:
          • Study Coordinator
          • Phone Number: 903122536666
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Istanbul, Turkey (Türkiye), 34668
        • Recruiting
        • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Istanbul, Turkey (Türkiye), 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1553)
        • Contact:
          • Study Coordinator
          • Phone Number: +902166065200
      • Samsun, Turkey (Türkiye), 55200
        • Recruiting
        • Samsun Medical Park Hastanesi-medical oncology (1560)
        • Contact:
  • United Kingdom
      • Manchester, United Kingdom, m20 4bx
        • Recruiting
        • The Christie NHS Foundation Trust ( Site 1608)
        • Contact:
          • Study Coordinator
          • Phone Number: +441614463000
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: 01223216083
    • England
      • Truro, England, United Kingdom, TR1 3LJ
        • Recruiting
        • The Royal Cornwall Hospital ( Site 1610)
        • Contact:
          • Study Coordinator
          • Phone Number: 01872258345
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Recruiting
        • The Beatson West of Scotland Cancer Centre ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Hammersmith and Fulham
      • London, Hammersmith and Fulham, United Kingdom, W6 8RF
        • Recruiting
        • Charing Cross Hospital-Oncology Research ( Site 1606)
        • Contact:
          • Study Coordinator
          • Phone Number: 0208 331 10277
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • Active, not recruiting
        • University College London Hospital ( Site 1612)
  • United States
    • California
      • Orange, California, United States, 92868
        • Active, not recruiting
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Center ( Site 0036)
        • Contact:
          • Study Coordinator
          • Phone Number: 650-725-2078
      • Riverside, California, United States, 92505
        • Recruiting
        • Kaiser Permanente Riverside Medical Center ( Site 0099)
        • Contact:
          • Study Coordinator
          • Phone Number: 951-809-8361
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Anschutz Cancer Pavilion ( Site 0046)
        • Contact:
          • Study Coordinator
          • Phone Number: 302-290-3598
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • University of Colorado Health - Highlands Ranch Hospital ( Site 0111)
        • Contact:
          • Study Coordinator
          • Phone Number: 302-290-3598
      • Lakewood, Colorado, United States, 80228
        • Active, not recruiting
        • Colorado Clinical Research ( Site 0067)
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • University of Colorado Health - Lone Tree Medical Center ( Site 0112)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-5146
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-737-8076
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists - South ( Site 7003)
        • Contact:
          • Study Coordinator
          • Phone Number: 727-364-9201
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-243-1543
      • Miami, Florida, United States, 33125
        • Active, not recruiting
        • Bruce W. Carter Veterans Affairs Medical Center ( Site 0082)
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center ( Site 0045)
        • Contact:
          • Study Coordinator
          • Phone Number: 773-702-7609
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: 973-330-2391
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa ( Site 0047)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-353-8155
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • University of Kentucky Chandler Medical Center ( Site 0048)
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Active, not recruiting
        • Ochsner Clinic Foundation ( Site 0108)
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Baltimore Veterans Affairs Medical Center ( Site 0069)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-707-4011
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Greenebaum Comprehensive Cancer Center ( Site 0049)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-707-4011
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Active, not recruiting
        • Henry Ford Hospital ( Site 0015)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • M Health Fairview Clinics and Surgery Center ( Site 0019)
        • Contact:
          • Study Coordinator
          • Phone Number: 612-626-1422
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Metro-Minnesota Community Clinical Oncology ( Site 0014)
        • Contact:
          • Study Coordinator
          • Phone Number: 952-993-3252
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Active, not recruiting
        • Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062)
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Recruiting
        • University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-559-8500
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Comprehensive Cancer Centers of Nevada ( Site 0010)
        • Contact:
          • Study Coordinator
          • Phone Number: 702-952-1251
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Atlantic Health System Morristown Medical Center ( Site 0115)
        • Contact:
          • Study Coordinator
          • Phone Number: 973-971-7960
      • New Brunswick, New Jersey, United States, 08901
        • Active, not recruiting
        • Rutgers Cancer Institute of New Jersey ( Site 0033)
    • New York
      • The Bronx, New York, United States, 10468
        • Recruiting
        • James J. Peters VA Medical Center ( Site 0088)
        • Contact:
          • Study Coordinator
          • Phone Number: 718-584-9000
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center ( Site 0043)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-844-3951
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • VA Portland Health Care System ( Site 0058)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-220-8262
      • Portland, Oregon, United States, 97239
        • Active, not recruiting
        • Oregon Health and Science University ( Site 0028)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Active, not recruiting
        • AHN Allegheny General Hospital ( Site 0001)
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Active, not recruiting
        • Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)
    • South Dakota
      • Pierre, South Dakota, United States, 57501
        • Recruiting
        • Avera Cancer Institute - Pierre ( Site 0118)
        • Contact:
          • Study Coordinator
          • Phone Number: 605-224-3370
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute- Research ( Site 0094)
        • Contact:
          • Study Coordinator
          • Phone Number: 605-322-6900
      • Yankton, South Dakota, United States, 57078
        • Recruiting
        • Avera Cancer Institute - Yankton ( Site 0117)
        • Contact:
          • Study Coordinator
          • Phone Number: 605-655-1800
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners ( Site 7000)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-218-4647
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Oncology - Central/South Texas ( Site 8003)
        • Contact:
          • Study Coordinator
          • Phone Number: 512-427-9400
      • Dallas, Texas, United States, 75246
        • Active, not recruiting
        • Texas Oncology - DFW ( Site 8001)
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Texas Oncology - Gulf Coast ( Site 8002)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-467-1722
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System ( Site 0054)
        • Contact:
          • Study Coordinator
          • Phone Number: 434-327-3029
      • Richmond, Virginia, United States, 23219
        • Active, not recruiting
        • VCU Health Adult Outpatient Pavillion ( Site 0061)
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Blue Ridge Cancer Care ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: 540-982-0237
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center ( Site 0013)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-413-9079
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • MEDICAL COLLEGE OF WISCONSIN ( Site 0020)
        • Contact:
          • Study Coordinator
          • Phone Number: 414-805-4600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
  • Has prostate cancer progression while on androgen deprivation therapy (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 by computed tomography/magnetic resonance imaging (CT/MRI).
  • Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
  • Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
  • Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
  • Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
  • Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
  • Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
  • If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression >4 weeks since the last flutamide treatment and >6 weeks since the last bicalutamide or nilutamide treatment
  • Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
  • Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
  • 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 can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom

Exclusion Criteria:

  • Has a gastrointestinal disorder that might affect absorption
  • Has a history of pituitary dysfunction
  • Has poorly controlled diabetes mellitus
  • Has clinically significant abnormal serum potassium or sodium level
  • Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
  • Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
  • Has a history of clinically significant ventricular arrhythmias
  • Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
  • Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications
  • Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization
  • Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization
  • Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
  • Has received colony-stimulating factors within 28 days before the date of randomization
  • Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
  • Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
  • Has a "superscan" bone scan
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has an active infection requiring systemic therapy
  • Has concurrent active HBV or known active HCV infection
  • Has a history of long QTc syndrome
  • Has any of the following at Screening Visit: hypotension (systolic BP <110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
  • Is unable to swallow capsules/tablets
  • Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
  • Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
  • Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle [Silybum marianum])
  • Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Abiraterone Acetate or Enzalutamide
Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.
Drug: Prednisone
Administered orally
Drug: Enzalutamide
Administered orally
Other Names:
  • XTANDI
Drug: Abiraterone acetate
Administered orally
Other Names:
  • ZYTIGA
  • YONSA
Experimental: Opevesostat
Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular [IM]) dose will also be provided to participants for use as rescue medication.
Drug: Fludrocortisone acetate
Administered orally
Drug: Hydrocortisone
Administered orally or IM as a rescue medication
Drug: Dexamethasone
Administered orally as rescue medication
Drug: Opevesostat
Administered orally
Other Names:
  • MK-5684

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants
Time Frame: Up to ~54 months
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.
Up to ~54 months
OS in AR LBD Mutation-Negative Participants
Time Frame: Up to ~54 months
OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-negative participants will be reported for each study arm.
Up to ~54 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST)
Time Frame: Up to ~54 months
TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.
Up to ~54 months
Objective Response (OR)
Time Frame: Up to ~54 months
OR is determined by PCWG-modified RECIST 1.1 as assessed by BICR.
Up to ~54 months
Duration of Response (DOR)
Time Frame: Up to ~54 months
DOR is determined by PCWG-modified RECIST 1.1 as assessed by BICR.
Up to ~54 months
Time to Pain Progression (TTPP)
Time Frame: Up to ~54 months
TTPP is assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and opiate analgesic use (Analgesic Quantification Algorithm [AQA] Score).
Up to ~54 months
Time to Prostate-specific Antigen (PSA) Progression
Time Frame: Up to ~54 months
The time from randomization to PSA progression. The PSA progression date is defined as the date of either: 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.
Up to ~54 months
Time to First Symptomatic Skeletal-related Event (SSRE)
Time Frame: Up to ~54 months
The time from randomization to the first occurrence of any of the following symptomatic skeletal-related events: 1) Use of EBRT to prevent or relieve skeletal symptoms; 2) new symptomatic pathologic bone fracture (vertebral or nonvertebral); 3) spinal cord compression; or 4) tumor-related orthopedic surgical intervention.
Up to ~54 months
Number of Participants Who Experience an Adverse Event
Time Frame: Up to ~54 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~54 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event
Time Frame: Up to ~54 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~54 months
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD Mutation-Positive Participants
Time Frame: Up to ~36 months
rPFS is defined as the time from randomization to the first documented disease progression per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-positive participants will be reported for each study arm.
Up to ~36 months
rPFS Per Prostate Cancer Working Group-modifiedRECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD Mutation-Negative Participants
Time Frame: Up to ~36 months
rPFS is defined as the time from randomization to the first documented disease progression per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-positive participants will be reported for each study arm.
Up to ~36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2023

Primary Completion (Estimated)

August 2, 2028

Study Completion (Estimated)

February 15, 2030

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5684-003
  • MK-5684-003 (Other Identifier: MSD)
  • jRCT2031240029 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
  • U1111-1287-5304 (Registry Identifier: UTN)
  • 2023-504899-25-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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