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)

May 25, 2026 updated by: Merck Sharp & Dohme LLC

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)

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Per Protocol Amendment 08, overall survival (OS) was moved to be a secondary outcome measure.

Study Type

Interventional

Enrollment (Estimated)

1314

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

  • Australia
    • New South Wales
      • Macquarie University, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University-MQ Health Clinical Trials Unit ( Site 0214)
        • Contact:
          • Study Coordinator
          • Phone Number: +61298122956
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital ( Site 0212)
        • Contact:
          • Study Coordinator
          • Phone Number: +61288905200
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0211)
        • Contact:
          • Study Coordinator
          • Phone Number: +61736467712
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health ( Site 0219)
        • Contact:
          • Study Coordinator
          • Phone Number: 0385722415
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210)
        • Contact:
          • Study Coordinator
          • Phone Number: 0385595000
  • Brazil
      • São Paulo, Brazil, 01321-001
        • Active, not recruiting
        • Hospital Paulistano ( Site 0259)
    • Ceará
      • Fortaleza, Ceará, Brazil, 60336-232
        • Active, not recruiting
        • CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0256)
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29043-260
        • Recruiting
        • Hospital Santa Rita de Cassia ( Site 0271)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 27 3334-8183
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40415-006
        • Active, not recruiting
        • Obras Sociais Irma Dulce ( Site 0255)
    • Maranhão
      • São Luís, Maranhão, Brazil, 65060-645
        • Active, not recruiting
        • Hospital São Domingos ( Site 0258)
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30380-472
        • Active, not recruiting
        • Hospital Mario Penna ( Site 0264)
      • Uberaba, Minas Gerais, Brazil, 38025-350
        • Recruiting
        • Universidade Federal do Triangulo Mineiro - Hospital de Clinicas ( Site 0262)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 34 991706916
    • Paraná
      • Curitiba, Paraná, Brazil, 80730-150
        • Active, not recruiting
        • Hospital Universitário Evangélico Mackenzie ( Site 0252)
      • Curitiba, Paraná, Brazil, 80510-130
        • Recruiting
        • ICTRIALS Pesquisa e Desenvolvimento ( Site 0274)
        • Contact:
          • Study Coordinator
          • Phone Number: +5541992620036
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Recruiting
        • Hospital São Lucas da PUCRS ( Site 0270)
        • Contact:
          • Study Coordinator
          • Phone Number: +5551999892554
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil, 88301-220
        • Recruiting
        • Clínica de Neoplasias Litoral ( Site 0269)
        • Contact:
          • Study Coordinator
          • Phone Number: +5549984292436
    • São Paulo
      • Bragança Paulista, São Paulo, Brazil, 12916-542
        • Recruiting
        • Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0251)
        • Contact:
          • Study Coordinator
          • Phone Number: +551124901366
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Hospital de Base de São José do Rio Preto ( Site 0275)
        • Contact:
          • Study Coordinator
          • Phone Number: +551732015054
      • Taubaté, São Paulo, Brazil, 12030-200
        • Active, not recruiting
        • Instituto do Câncer Brasil - Unidade Taubaté ( Site 0263)
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute (Site 0281)
        • Contact:
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2N1
        • Recruiting
        • Trillium Health Partners - Credit Valley Hospital ( Site 0289)
        • Contact:
          • Study Coordinator
          • Phone Number: 9058134299
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus ( Site 0286)
        • Contact:
          • Study Coordinator
          • Phone Number: 613-737-7700
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute ( Site 0285)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-480-5000
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Active, not recruiting
        • Centre Hospitalier de l'Université de Montréal ( Site 0276)
      • Québec, Quebec, Canada, G1J 1Z4
        • Active, not recruiting
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0277)
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4810218
        • Recruiting
        • CIDO SpA-Oncology ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Maule Region
      • Talca, Maule Region, Chile, 3465584
        • Recruiting
        • Clinica Universidad Catolica del Maule-Oncology ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 8330024
        • Recruiting
        • Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +56229490970
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS-ACEREY ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Recruiting
        • The Second Hospital Of Anhui Medical University ( Site 1633)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 02782201756
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital-Urology ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Beijing, Beijing Municipality, China, 100853
        • Active, not recruiting
        • First Medical Center of Chinese PLA General Hospital ( Site 1601)
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer hospital-Urinary Surgery ( Site 1620)
        • Contact:
          • Study Coordinator
          • Phone Number: 86 010 8812 1122
      • Beijing, Beijing Municipality, China, 130021
        • Recruiting
        • Beijing Cancer Hospital ( Site 1623)
        • Contact:
          • Study Coordinator
          • Phone Number: +861088196393
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400038
        • Active, not recruiting
        • Southwest Hospital of Third Military Medical University ( Site 1645)
      • Chongqing, Chongqing Municipality, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: 02365075629
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 1639)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 591-87981262
    • Guangdong
      • Guangzhou, Guangdong, China, 510700
        • Recruiting
        • Sun Yat-sen University Cancer Center-Urology Surgery ( Site 1638)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 20-87341851
      • Guangzhou, Guangdong, China, 510030
        • Recruiting
        • The first affiliated hospital of Guangzhou medical university ( Site 1637)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 2083062114
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital-Urinary surgery ( Site 1631)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613907110640
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 1632)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-83665555
      • Wuhan, Hubei, China, 430014
        • Recruiting
        • The Central Hospital of Wuhan ( Site 1635)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 02782211667
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 1630)
        • Contact:
          • Study Coordinator
          • Phone Number: +86073189762271
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1615)
        • Contact:
          • Study Coordinator
          • Phone Number: 86-025-83106666
      • Nantong, Jiangsu, China, 226361
        • Recruiting
        • Nantong Tumor Hospital-Urology ( Site 1609)
        • Contact:
          • Study Coordinator
          • Phone Number: 0513-86729024
      • Wuxi, Jiangsu, China, 214023
        • Recruiting
        • Wuxi People's Hospital ( Site 1612)
        • Contact:
          • Study Coordinator
          • Phone Number: 0510-85350351
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University-Oncology department ( Site 1618)
        • Contact:
          • Study Coordinator
          • Phone Number: 029-85323112
      • Xi'an, Shaanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University-Oncology Department ( Site 1619)
        • Contact:
          • Study Coordinator
          • Phone Number: 029-87679000
    • Shandong
      • Yantai, Shandong, China, 264099
        • Recruiting
        • Yantai Yuhuangding Hospital ( Site 1622)
        • Contact:
          • Study Coordinator
          • Phone Number: 86 0535 6691999
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200001
        • Active, not recruiting
        • Renji Hosp Shanghai Jiaotong U School of Med ( Site 1624)
      • Shanghai, Shanghai Municipality, China, 200041
        • Recruiting
        • Huadong Hospital Affiliated to Fudan University-Urology ( Site 1613)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-62483180-571301
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University-Urology Surgery ( Site 1642)
        • Contact:
          • Study Coordinator
          • Phone Number: +86028-85422114
      • Nanchong, Sichuan, China, 500643
        • Recruiting
        • Nanchong Central Hospital-urology ( Site 1647)
        • Contact:
          • Study Coordinator
          • Phone Number: 0817-2606822
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300211
        • Recruiting
        • The Second Hospital of Tianjin Medical University ( Site 1616)
        • Contact:
          • Study Coordinator
          • Phone Number: +862288326748
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Recruiting
        • Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 1644)
        • Contact:
          • Study Coordinator
          • Phone Number: 86 09917819156
    • Yunnan
      • Kunming, Yunnan, China, 650107
        • Recruiting
        • Yunnan Province Cancer Hospital ( Site 1643)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital-Urology ( Site 1641)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-85893646
      • Jiaxing, Zhejiang, China, 314001
        • Recruiting
        • The First Hospital of Jiaxing-urology ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: 86-0573-82519999
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • Ningbo First Hospital-Urology ( Site 1608)
        • Contact:
          • Study Coordinator
          • Phone Number: +8616301635665
      • Wenzhou, Zhejiang, China, 325015
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University ( Site 1604)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613601635665
  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110121
        • Active, not recruiting
        • Los Cobos Medical Center ( Site 0336)
      • Bogotá, Bogota D.C., Colombia, 111321
        • Recruiting
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0326)
        • Contact:
          • Study Coordinator
          • Phone Number: 6017058333
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Recruiting
        • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0327)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3158505190
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Recruiting
        • IMAT S.A.S ( Site 0329)
        • Contact:
          • Study Coordinator
          • Phone Number: +573135342052
    • Santander Department
      • Piedecuesta, Santander Department, Colombia, 681017
        • Recruiting
        • Fundación Cardiovascular de Colombia ( Site 0328)
        • 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 0334)
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 0330)
        • Contact:
          • Study Coordinator
          • Phone Number: +573133288646
  • Costa Rica
      • San José, Costa Rica, 10103
        • Recruiting
        • Onco Tech, S.A. ( Site 0376)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Provincia de San José
      • San José, Provincia de San José, Costa Rica, 10103
        • Recruiting
        • CIMCA-Hemato-Oncology ( Site 0380)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Santa Ana, Provincia de San José, Costa Rica, 10903
        • Recruiting
        • Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0379)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • Czechia
      • Olomouc, Czechia, 77900
        • Recruiting
        • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0405)
        • Contact:
          • Study Coordinator
          • Phone Number: +420588444295
      • Prague, Czechia, 12808
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze ( Site 0406)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224962219
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 656 53
        • Recruiting
        • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: +420543136216
    • Liberec Region
      • Liberec, Liberec Region, Czechia, 460 01
        • Active, not recruiting
        • Krajská nemocnice Liberec-Department of Urology ( Site 0407)
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224434700
    • South Moravian
      • Brno, South Moravian, Czechia, 602 00
        • Recruiting
        • Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: +420543183087
  • Estonia
    • Harju
      • Tallinn, Harju, Estonia, 11314
        • Active, not recruiting
        • East-Tallinn Central Hospital ( Site 1528)
      • Tallinn, Harju, Estonia, 13419
        • Recruiting
        • North Estonia Medical Centre Foundation ( Site 1526)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Pärnumaa
      • Pärnu, Pärnumaa, Estonia, 80010
    • Tartu
      • Tartu, Tartu, Estonia, 50406
        • Recruiting
        • Tartu University Hospital-Radiotherapy and oncology ( Site 1527)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • France
      • Paris, France, 75014
        • Active, not recruiting
        • Groupe Hospitalier Paris Saint Joseph ( Site 0465)
    • Alsace
      • Strasbourg, Alsace, France, 67200
        • Recruiting
        • Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0451)
        • Contact:
          • Study Coordinator
          • Phone Number: +33368767204
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Recruiting
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0461)
        • Contact:
          • Study Coordinator
          • Phone Number: +33556333333
    • Auvergne-Rhône-Alpes
      • Lyon Cedex08, Auvergne-Rhône-Alpes, France, 69373
        • Recruiting
        • CENTRE LEON BERARD ( Site 0459)
        • Contact:
          • Study Coordinator
          • Phone Number: 33469856243
    • Finistere
      • Brest, Finistere, France, 29609
        • Active, not recruiting
        • CHU-BREST Cavale Blanche ( Site 0456)
    • Haute-Garonne
      • Quint-Fonsegrives, Haute-Garonne, France, 31130
        • Active, not recruiting
        • Ramsay Santé - Clinical La Croix Du Sud ( Site 0460)
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59000
        • Recruiting
        • Centre Bourgogne ( Site 0464)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 3 20 00 97 57
    • Hauts-de-Seine
      • Suresnes, Hauts-de-Seine, France, 92150
        • Active, not recruiting
        • Hôpital Foch ( Site 0455)
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63003
        • Active, not recruiting
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0454)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Active, not recruiting
        • Gustave Roussy ( Site 0452)
    • Vaucluse
      • Avignon, Vaucluse, France, 84000
        • Active, not recruiting
        • Sainte Catherine Institut du Cancer Avignon Provence ( Site 0458)
  • Germany
      • Berlin, Germany, 10967
        • Recruiting
        • Vivantes Klinikum Am Urban ( Site 0512)
        • Contact:
          • Study Coordinator
          • Phone Number: 004930130226301
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049 30 450615297
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Recruiting
        • Universitaetsklinikum Freiburg-Klinik für Urologie ( Site 0506)
        • Contact:
          • Study Coordinator
          • Phone Number: +4976127028900
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg ( Site 0531)
        • Contact:
          • Study Coordinator
          • Phone Number: +496221565982
      • Nürtingen, Baden-Wurttemberg, Germany, 72622
        • Recruiting
        • Studienpraxis Urologie ( Site 0529)
        • Contact:
          • Study Coordinator
          • Phone Number: 491703809223
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Active, not recruiting
        • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0521)
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0523)
        • Contact:
          • Study Coordinator
          • Phone Number: +499417827524
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • Completed
        • Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 0510)
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Recruiting
        • Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Urologie ( Site 0527)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • North Rhine-Westphalia
      • Bergisch Gladbach, North Rhine-Westphalia, Germany, 51465
        • Recruiting
        • Marien-Krankenhaus ( Site 0515)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Active, not recruiting
        • Universitaetsklinikum Koeln ( Site 0518)
      • Duisburg, North Rhine-Westphalia, Germany, 47169
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Completed
        • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0528)
  • Greece
    • Achaia
      • Pátrai, Achaia, Greece, 26504
        • Active, not recruiting
        • UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0553)
    • Attica
      • Athens, Attica, Greece, 115 28
        • Recruiting
        • Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0551)
        • Contact:
          • Study Coordinator
          • Phone Number: +302132162513
      • Chaïdári, Attica, Greece, 124 62
        • Recruiting
        • ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Site 0552)
        • Contact:
          • Study Coordinator
          • Phone Number: +302105832547
  • Guatemala
      • Guatemala City, Guatemala, 01009
        • Recruiting
        • MEDI-K ( Site 0576)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Guatemala City, Guatemala, 01010
        • Recruiting
        • CELAN,S.A ( Site 0579)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Guatemala City, Guatemala, 01010
        • Recruiting
        • INTEGRA Cancer Institute-Oncology ( Site 0578)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Guatemala City, Guatemala, 01010
        • Recruiting
        • Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0577)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Guatemala City, Guatemala, 01015
        • Recruiting
        • Sanatorio Nuestra Senora del Pilar ( Site 0580)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • Hong Kong
      • Central, Hong Kong, 999077
        • Recruiting
        • Hong Kong Integrated Oncology Centre ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: +85237006888
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +85222553838
  • Hungary
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0632)
        • Contact:
          • Study Coordinator
          • Phone Number: +3652411717
    • Borsod-Abauj Zemplen county
      • Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526
        • Recruiting
        • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C ( Site 0630)
        • Contact:
          • Study Coordinator
          • Phone Number: +36204108060
    • Nógrád megye
      • Salgótarján, Nógrád megye, Hungary, 3100
        • Recruiting
        • Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0636)
        • Contact:
          • Study Coordinator
          • Phone Number: +3632522000
    • Pest County
      • Budapest, Pest County, Hungary, 1122
        • Recruiting
        • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0631)
        • Contact:
          • Study Coordinator
          • Phone Number: +36122486001171
  • Ireland
      • Dublin, Ireland, D24 NR0A
        • Recruiting
        • Tallaght University Hospital ( Site 0651)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Dublin
      • Dublin, Dublin, Ireland, D04 T6F4
        • Recruiting
        • St. Vincent's University Hospital ( Site 0652)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • Israel
      • Afula, Israel, 1834111
        • Recruiting
        • Emek Medical Center ( Site 0680)
        • Contact:
          • Study Coordinator
          • Phone Number: 0546708579
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Oncology Division ( Site 0676)
        • Contact:
          • Study Coordinator
          • Phone Number: 04-7776234
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 0683)
        • Contact:
          • Study Coordinator
          • Phone Number: 02-6777111
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 0679)
        • Contact:
          • Study Coordinator
          • Phone Number: 02-666-6044
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center. ( Site 0682)
        • Contact:
          • Study Coordinator
          • Phone Number: 0503745684
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 0678)
        • Contact:
          • Study Coordinator
          • Phone Number: 039378074
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 0677)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-35302191
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center ( Site 0681)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-36972951
  • Italy
      • Catania, Italy, 95126
        • Recruiting
        • Ospedale Cannizzaro ( Site 1455)
        • Contact:
          • Study Coordinator
          • Phone Number: +393487142015
      • Foggia, Italy, 71100
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 1456)
        • Contact:
          • Study Coordinator
          • Phone Number: +390881736426
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele-Oncologia Medica ( Site 1451)
        • Contact:
          • Study Coordinator
          • Phone Number: +390226435668
      • Terni, Italy, 05100
        • Recruiting
        • Azienda Ospedaliera Santa Maria Terni ( Site 1458)
        • Contact:
          • Study Coordinator
          • Phone Number: +390744205410
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Active, not recruiting
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1454)
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1452)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390223903033
  • Japan
      • Akita, Japan, 010-8543
        • Recruiting
        • Akita University Hospital ( Site 0728)
        • Contact:
          • Study Coordinator
          • Phone Number: +81188341111
      • Fukuoka, Japan, 812-8582
        • Active, not recruiting
        • Kyushu University Hospital ( Site 0745)
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital ( Site 0758)
        • Contact:
          • Study Coordinator
          • Phone Number: +81245471111
      • Gifu, Japan, 501-1112
        • Recruiting
        • Gifu University Hospital ( Site 0736)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-58-230-6000
      • Hiroshima, Japan, 734-8551
        • Active, not recruiting
        • Hiroshima University Hospital ( Site 0743)
      • Kagoshima, Japan, 890-8520
        • Active, not recruiting
        • Kagoshima University Hospital ( Site 0754)
      • Kumamoto, Japan, 860-0008
        • Recruiting
        • National Hospital Organization Kumamoto Medical Center ( Site 0749)
        • Contact:
          • Study Coordinator
          • Phone Number: +81963536501
      • Miyazaki, Japan, 880-8510
        • Recruiting
        • Miyazaki Prefectural Miyazaki Hospital ( Site 0752)
        • Contact:
          • Study Coordinator
          • Phone Number: +81985244181
      • Miyazaki, Japan, 889-1692
        • Recruiting
        • University of Miyazaki Hospital ( Site 0751)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-98-585-1510
      • Nagano, Japan, 381-8551
        • Recruiting
        • Nagano Municipal Hospital ( Site 0757)
        • Contact:
          • Study Coordinator
          • Phone Number: +81262951199
      • Ōita, Japan, 870-0263
        • Completed
        • National Hospital Organization Oita Medical Center ( Site 0750)
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Recruiting
        • Toho University Sakura Medical Center ( Site 0730)
        • Contact:
          • Study Coordinator
          • Phone Number: +81434628811
    • Fukui
      • Eiheiji-cho,Yoshida-gun, Fukui, Japan, 910-1193
        • Recruiting
        • University of Fukui Hospital ( Site 0735)
        • Contact:
          • Study Coordinator
          • Phone Number: +81776613111
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Recruiting
        • Hospital of the University of Occupational and Environmental Health, Japan ( Site 0746)
        • Contact:
          • Study Coordinator
          • Phone Number: +81936031611
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Recruiting
        • Sapporo Medical University Hospital ( Site 0726)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-611-2111
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital ( Site 0756)
        • Contact:
          • Study Coordinator
          • Phone Number: +81117161161
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital ( Site 0741)
        • Contact:
          • Study Coordinator
          • Phone Number: +81783825111
    • Ishikawa-ken
      • Mukai-awagasaki, Ishikawa-ken, Japan, 920-0265
        • Recruiting
        • Kanazawa Medical University Hospital ( Site 0734)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-76-286-3511
    • Kagawa-ken
      • Kita, Kagawa-ken, Japan, 761-0701
        • Recruiting
        • Kagawa University Hospital ( Site 0744)
        • Contact:
          • Study Coordinator
          • Phone Number: +81878985111
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center ( Site 0733)
        • Contact:
          • Study Coordinator
          • Phone Number: +81452615656
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Active, not recruiting
        • Mie University Hospital ( Site 0737)
    • Nagasaki
      • Ōmura, Nagasaki, Japan, 856-8562
        • Recruiting
        • National Hospital Organization Nagasaki Medical Center ( Site 0748)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-957-52-3121
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Recruiting
        • Nara Medical University Hospital ( Site 0742)
        • Contact:
          • Study Coordinator
          • Phone Number: +81744223051
    • Okinawa
      • Shimajiri, Okinawa, Japan, 901-0417
        • Active, not recruiting
        • Nanbu Tokushukai Hospital ( Site 0755)
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 0739)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-804-0101
      • Sakai, Osaka, Japan, 599-8247
        • Active, not recruiting
        • Bell Land General Hospital ( Site 0740)
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • The University of Osaka Hospital ( Site 0738)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6879-5111
    • Saga-ken
      • Saga, Saga-ken, Japan, 840-8571
        • Recruiting
        • Saga-Ken Medical Centre Koseikan ( Site 0747)
        • Contact:
          • Study Coordinator
          • Phone Number: +81952242171
    • Tokyo
      • Itabashiku, Tokyo, Japan, 173-8610
        • Completed
        • Nihon University Itabashi Hospital ( Site 0732)
      • Minato, Tokyo, Japan, 105-8471
        • Recruiting
        • The Jikei University Hospital ( Site 0731)
        • Contact:
          • Study Coordinator
          • Phone Number: +81339728111
  • Latvia
      • Liepāja, Latvia, LV3414
        • Active, not recruiting
        • Liepaja Regional Hospital ( Site 1553)
      • Riga, Latvia, LV-1002
        • Recruiting
        • Pauls Stradins Clinical Univeristy Hospital-Urological department ( Site 1551)
        • Contact:
          • Study Coordinator
          • Phone Number: +371 29262596
  • Lithuania
    • Kaunas County
      • Kaunas, Kaunas County, Lithuania, 50161
        • Recruiting
        • Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 1576)
        • Contact:
          • Study Coordinator
          • Phone Number: +37037326090
    • Vilniaus Miestas
      • Vilnius, Vilniaus Miestas, Lithuania, 08660
        • Recruiting
        • National Cancer Institute ( Site 1577)
        • Contact:
          • Study Coordinator
          • Phone Number: +37052786815
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: +60326155810
    • Johor
      • Johor Bahru, Johor, Malaysia, 81100
        • Recruiting
        • Hospital Sultan Ismail ( Site 0905)
        • Contact:
          • Study Coordinator
          • Phone Number: +6073565155
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: +60479492351
    • Putrajaya
      • Putrajaya, Putrajaya, Malaysia, 62250
        • Completed
        • National Cancer Institute ( Site 0904)
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Sarawak General Hospital-Radiotherapy Unit ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: +6082276820
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44630
        • Active, not recruiting
        • CIO - Centro de Inmuno-Oncología de Occidente ( Site 0928)
    • Mexico City
      • Mexico City, Mexico City, Mexico, 03100
        • Active, not recruiting
        • Health Pharma Professional Research S.A. de C.V: ( Site 0929)
      • Mexico City, Mexico City, Mexico, 11810
        • Active, not recruiting
        • Higiea Oncologia ( Site 0938)
      • Tlalpan, Mexico City, Mexico, 14308
        • Active, not recruiting
        • Quemex Medical and Research ( Site 0937)
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Active, not recruiting
        • Filios Alta Medicina ( Site 0931)
      • Monterrey, Nuevo León, Mexico, 64460
        • Active, not recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0932)
      • Monterrey, Nuevo León, Mexico, 64718
        • Active, not recruiting
        • Eukarya Pharmasite S.C. ( Site 0939)
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Active, not recruiting
        • Centro de Investigacion Clinica de Oaxaca ( Site 0934)
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital ( Site 1033)
        • Contact:
          • Study Coordinator
          • Phone Number: +6493074949 x 21468
    • Otago
      • Dunedin, Otago, New Zealand, 9016
        • Completed
        • Dunedin Hospital ( Site 1032)
  • Peru
      • Lima, Peru, 15036
        • Recruiting
        • IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1052)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Lima, Peru, 15036
        • Recruiting
        • Oncosalud-Clinical Research ( Site 1057)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Lima, Peru, 15036
        • Recruiting
        • Aliada-Oncologìa ( Site 1055)
        • Contact:
          • Study Coordinator
          • Phone Number: 5116505000
      • Lima, Peru, 15038
        • Active, not recruiting
        • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1054)
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • Unidade Local de Saude de Braga - Hospital de Braga ( Site 1151)
        • Contact:
          • Study Coordinator
          • Phone Number: 351253027249
      • Lisbon, Portugal, 1350-352
        • Recruiting
        • Hospital CUF - Tejo ( Site 1157)
        • Contact:
          • Study Coordinator
          • Phone Number: +35121 392 6100
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1153)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351217805000
      • Porto, Portugal, 4099-001
        • Recruiting
        • Unidade Local de Saude de Santo António - Hospital Santo António ( Site 1152)
        • Contact:
          • Study Coordinator
          • Phone Number: 351222077500
    • Lisbon District
      • Alcabideche, Lisbon District, Portugal, 2755-009
        • Recruiting
        • Hospital de Cascais Doutor José de Almeida ( Site 1158)
        • Contact:
          • Study Coordinator
          • Phone Number: (351) 214653000
    • Porto District
      • Vila Nova de Gaia, Porto District, Portugal, 4434-502
        • Recruiting
        • Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1156)
        • Contact:
          • Study Coordinator
          • Phone Number: 351227865100
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Recruiting
        • Ad-Vance Medical Research-Research ( Site 1177)
        • Contact:
          • Study Coordinator
          • Phone Number: +1787-651-6697
      • Ponce, Puerto Rico, 00716
        • Completed
        • Advance Urology and Laparoscopic Center ( Site 1178)
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Pan American Center for Oncology Trials - Ciudadela ( Site 1176)
        • Contact:
          • Study Coordinator
          • Phone Number: +1 787-407-3333
  • Romania
      • Bucharest, Romania, 050659
        • Recruiting
        • Spitalul Clinic ''Prof Dr. Theodor Burghele" (Site 1505)
        • Contact:
    • Bucharest
      • Bucharest, Bucharest, Romania, 011461
        • Recruiting
        • Spitalul Universitar de Urgență Elias ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: +40213161600
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Active, not recruiting
        • Cardiomed SRL Cluj-Napoca ( Site 1503)
      • Florești, Cluj, Romania, 407280
        • Active, not recruiting
        • SC Radiotherapy Center Cluj SRL ( Site 1502)
    • Dolj
      • Craiova, Dolj, Romania, 200746
        • Active, not recruiting
        • Centrul de Oncologie "Sfântul Nectarie" ( Site 1501)
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +6564368000
      • Singapore, Central Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital-Medical Oncology ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +65-62566011
      • Singapore, Central Singapore, Singapore, 169608
        • Recruiting
        • Singapore General Hospital ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Singapore, Central Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • Slovakia
    • Nitra Region
      • Nitra, Nitra Region, Slovakia, 949 01
        • Recruiting
        • UROEXAM ( Site 1479)
        • Contact:
          • Study Coordinator
          • Phone Number: +421377729428
    • Trenčín Region
      • Trenčín, Trenčín Region, Slovakia, 911 01
        • Recruiting
        • Privatna Urologicka Ambulancia ( Site 1478)
        • Contact:
          • Study Coordinator
          • Phone Number: +421905343753
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6055
        • Recruiting
        • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1230)
        • Contact:
          • Study Coordinator
          • Phone Number: 27413630581
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • Wits Clinical Research ( Site 1234)
        • Contact:
          • Study Coordinator
          • Phone Number: +27113390620
      • Pretoria, Gauteng, South Africa, 0040
        • Recruiting
        • Wilgers Oncology Centre ( Site 1232)
        • Contact:
          • Study Coordinator
          • Phone Number: +27128072744
      • Pretoria, Gauteng, South Africa, 0181
        • Recruiting
        • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1236)
        • Contact:
          • Study Coordinator
          • Phone Number: +27123466701
      • Pretoria, Gauteng, South Africa, 0084
        • Recruiting
        • Curo Oncology. ( Site 1237)
        • Contact:
          • Study Coordinator
          • Phone Number: +27 12 335 6771
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Completed
        • Cape Town Oncology Trials ( Site 1233)
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital-Urology ( Site 1251)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-053-3027
      • Seoul, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1255)
        • Contact:
          • Study Coordinator
          • Phone Number: +82222581401
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center-Center for Urologic Cancer ( Site 1254)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-31-920-1740
      • Seongnam, Kyonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital-Urology ( Site 1253)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-31-787-7342
    • Kyongsangbuk-do
      • Buk-gu, Kyongsangbuk-do, South Korea, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital-Urology ( Site 1252)
        • Contact:
          • Study Coordinator
          • Phone Number: +82532002400
    • Kyongsangnam-do
      • Pusan, Kyongsangnam-do, South Korea, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital ( Site 1256)
        • Contact:
          • Study Coordinator
          • Phone Number: +82553602672
  • Spain
      • Burgos, Spain, 09006
        • Recruiting
        • Hospital Universitario de Burgos-Oncología ( Site 1281)
        • Contact:
          • Study Coordinator
          • Phone Number: +34947281800 (35729)
      • Málaga, Spain, 29004
        • Recruiting
        • Hospital Quirón Málaga ( Site 1286)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 95 194 00 00
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Tauli-oncologia ( Site 1282)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932240084
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Recruiting
        • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1284)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932275402
    • Gerona
      • Girona, Gerona, Spain, 17007
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Girona ( Site 1285)
        • Contact:
          • Study Coordinator
          • Phone Number: +34972225834
    • La Coruna
      • A Coruña, La Coruna, Spain, 15006
        • Recruiting
        • Complexo Hospitalario Universitario A Coruna ( Site 1288)
        • Contact:
          • Study Coordinator
          • Phone Number: 981178000 Ext 291471
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
        • Recruiting
        • Hospital Insular de Gran Canaria-Oncology ( Site 1280)
        • Contact:
          • Study Coordinator
          • Phone Number: +34928441738
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1283)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914521987
  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 64
        • Recruiting
        • Karolinska Universitetssjukhuset Solna ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +46812370000
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 751 85
        • Recruiting
        • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: 0046186110000
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1331)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-7-7317123 #3267
      • Kaohsiung City, Taiwan, 81362
        • Recruiting
        • Kaohsiung Veterans General Hospital ( Site 1337)
        • Contact:
          • Study Coordinator
          • Phone Number: +88673422121x73016
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital-Department of Urology ( Site 1335)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-4-2205-2121
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital ( Site 1338)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-4-23592525
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital ( Site 1332)
        • Contact:
          • Study Coordinator
          • Phone Number: +886228757519x315
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1334)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-4-23592525
    • Tainan
      • Tainan, Tainan, Taiwan, 71004
        • Recruiting
        • Chi Mei Medical Center ( Site 1336)
        • Contact:
          • Study Coordinator
          • Phone Number: 886 933072414
  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 1356)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Bangkok, Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University ( Site 1355)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Changwat Khon Kaen
      • Muang, Changwat Khon Kaen, Thailand, 40002
        • Active, not recruiting
        • Faculty of Medicine - Khon Kaen University ( Site 1351)
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Recruiting
        • Songklanagarind hospital ( Site 1352)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital ( Site 1353)
        • 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 1379)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1376)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1377)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • Koc Universitesi Hastanesi ( Site 1384)
        • Contact:
          • Study Coordinator
          • Phone Number: +908502508250
      • Istanbul, Turkey (Türkiye), 34147
        • Recruiting
        • T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1381)
        • Contact:
          • Study Coordinator
          • Phone Number: +902124147171
      • Istanbul, Turkey (Türkiye), 34668
        • Recruiting
        • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1383)
        • 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 1378)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Izmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Universitesi Hastanesi-Medical Oncology ( Site 1380)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Samsun, Turkey (Türkiye), 55200
        • Recruiting
        • Samsun Medical Park Hastanesi-medical oncology ( Site 1382)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
  • United Kingdom
      • Manchester, United Kingdom, m20 4bx
        • Recruiting
        • The Christie NHS Foundation Trust ( Site 1436)
        • Contact:
          • Study Coordinator
          • Phone Number: +441614463000
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital ( Site 1426)
        • Contact:
          • Study Coordinator
          • Phone Number: 01223216083
    • Derbyshire
      • Derby, Derbyshire, United Kingdom, DE22 3NE
        • Recruiting
        • Royal Derby Hospital ( Site 1431)
        • Contact:
          • Study Coordinator
          • Phone Number: +441332340131
    • Devon
      • Torquay, Devon, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay Hospital ( Site 1429)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
    • England
      • Northwood, England, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Cancer Centre ( Site 1440)
        • Contact:
          • Study Coordinator
          • Phone Number: 1-888-577-8839
      • Truro, England, United Kingdom, TR1 3LJ
        • Recruiting
        • The Royal Cornwall Hospital ( Site 1430)
        • Contact:
          • Study Coordinator
          • Phone Number: 01872258345
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Recruiting
        • The Beatson West of Scotland Cancer Centre ( Site 1428)
        • 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 1434)
        • Contact:
          • Study Coordinator
          • Phone Number: 0208 331 10277
    • London, City of
      • London, London, City of, United Kingdom, SE1 9RT
        • Active, not recruiting
        • Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435)
      • London, London, City of, United Kingdom, SW17 0QT
        • Completed
        • St. George's Hospital-Oncology ( Site 1441)
      • London, London, City of, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital ( Site 1437)
        • Contact:
          • Study Coordinator
          • Phone Number: 0203 447 3042
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX4 6LB
        • Active, not recruiting
        • GenesisCare - Oxford ( Site 1442)
    • Windsor And Maidenhead
      • Windsor, Windsor And Maidenhead, United Kingdom, SL4 3HD
        • Active, not recruiting
        • GenesisCare - Windsor ( Site 1443)
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • The University of Arizona Cancer Center - North Campus ( Site 0073)
        • Contact:
          • Study Coordinator
          • Phone Number: 520-626-1068
    • California
      • Los Angeles, California, United States, 90404
        • Recruiting
        • UCLA Hematology/Oncology - Santa Monica ( Site 0044)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120)
        • Contact:
          • Arash Rezazadeh Kalebasty
          • Phone Number: 502-472-3237
          • Email: arez@hs.uci.edu
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Center ( Site 0036)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Redlands, California, United States, 92373
        • Completed
        • Emad Ibrahim,MD,INC. ( Site 0012)
      • Riverside, California, United States, 92505
        • Recruiting
        • Kaiser Permanente Riverside Medical Center ( Site 0099)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114)
        • Contact:
          • Study Coordinator
          • Phone Number: 916-734-3772
      • San Francisco, California, United States, 94121
        • Recruiting
        • San Francisco VA Health Care System ( Site 0093)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus ( Site 0046)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • UCHealth Highlands Ranch Hospital ( Site 0111)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-516-1000
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Colorado Clinical Research ( Site 0067)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • University of Colorado Health - Lone Tree Medical Center ( Site 0112)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-470-9107
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Active, not recruiting
        • Florida Cancer Specialists - South ( Site 7003)
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Cancer Center ( Site 0107)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • Memorial Hospital West-Memorial Cancer Institute ( Site 0109)
        • Contact:
          • Study Coordinator
          • Phone Number: 954-265-4325
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital-Northside Hospital Oncology Network ( Site 0100)
        • Contact:
          • Study Coordinator
          • Phone Number: 770-590-8311
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois Cancer Care ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Urology of Indiana - Carmel ( Site 0055)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • University of Kentucky Chandler Medical Center ( Site 0048)
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Baltimore Veterans Affairs Medical Center ( Site 0069)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Greenebaum Comprehensive Cancer Center ( Site 0049)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Chesapeake Urology ( Site 0009)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital ( Site 0015)
        • Contact:
          • Study Coordinator
          • Phone Number: 313-916-1784
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan ( Site 0005)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Recruiting
        • HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St. Vincent Frontier Cancer Center-Research ( Site 0037)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care-Research Department ( Site 0078)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Comprehensive Cancer Centers of Nevada ( Site 0010)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey ( Site 0033)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • New York
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Associated Medical Professionals - Urology ( Site 0081)
        • Contact:
          • Study Coordinator
          • Phone Number: 315-478-4185
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center ( Site 0043)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Gahanna, Ohio, United States, 43230
        • Active, not recruiting
        • Central Ohio Urology Group - Gahanna ( Site 0098)
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: 740-454-5271
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • MidLantic urology ( Site 0022)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center ( Site 0076)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Recruiting
        • Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • South Dakota
      • Pierre, South Dakota, United States, 57501
        • Active, not recruiting
        • Avera Cancer Institute - Pierre ( Site 0118)
      • 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
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The West Clinic, PLLC dba West Cancer Center ( Site 0063)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • 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
        • Recruiting
        • Texas Oncology - DFW ( Site 8001)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-370-1000
      • Houston, Texas, United States, 77024
        • Recruiting
        • Texas Oncology - Gulf Coast ( Site 8002)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System ( Site 0054)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute ( Site 0017)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists (VCS) ( Site 8004)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • VCU Health Adult Outpatient Pavillion ( Site 0061)
        • Contact:
          • Study Coordinator
          • Phone Number: 804-628-6430
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Blue Ridge Cancer Care ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Spokane Urology ( Site 0035)
        • Contact:
          • Study Coordinator
          • Phone Number: 888-577-8839
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Northwest Cancer Specialists (Compass Oncology) ( Site 8008)
        • Contact:
          • Study Coordinator
          • Phone Number: 971-708-7600
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • MEDICAL COLLEGE OF WISCONSIN ( Site 0020)
        • Contact:
          • Study Coordinator
          • Phone Number: 414-805-6700

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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
Experimental: Hormone Replacement Therapy (HRT) + Opevesostat
Participants receive opevesostat 5 mg by oral tablets twice daily (BID) plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily (QD) continuously until disease progression. Hydrocortisone 100 mg (oral or intramuscular [IM]) will also be provided to participants for use as rescue medication.
Drug: Dexamethasone
Administered orally
Drug: Fludrocortisone acetate
Administered orally
Drug: Hydrocortisone
Administered orally or IM as a rescue drug
Drug: Opevesostat
Administered orally
Other Names:
  • MK-5684
Active Comparator: Alternative Next-Generation Hormonal Agent (NHA)
Participants receive abiraterone 1000mg QD by oral tablets plus prednisone 5 mg BID by oral tablets or enzalutamide 160 mg QD by oral tablets until disease progression.
Drug: Enzalutamide
Administered orally
Other Names:
  • Xtandi
Drug: Abiraterone acetate
Administered orally
Other Names:
  • Zytiga
  • Yonsa
Drug: Prednisone acetate
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Progression-Free Survival (rPFS)
Time Frame: Up to approximately 52 months
rPFS is defined as the time from randomization to the first documented disease progression per PCWG-modified RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Up to approximately 52 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 82 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 82 months
Duration of Response (DOR)
Time Frame: Up to approximately 82 months
For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression per PCWG-modified RECIST 1.1 as assessed by BICR or death from any cause, whichever occurs first.
Up to approximately 82 months
Time to Pain Progression (TTPP)
Time Frame: Up to approximately 82 months
TTPP is defined as the time from randomization to pain progression. TTTP 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 approximately 82 months
Time to Prostate-specific Antigen (PSA) Progression
Time Frame: Up to approximately 82 months
The time to PSA progression is the time from randomization to PSA progression. The PSA progression date is defined as the date of: 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR 2) ≥25% increase and ≥2 ng/mL increase from baseline.
Up to approximately 82 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 82 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 82 months
Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
Time Frame: Up to approximately 82 months
TFST is defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever occurred first.
Up to approximately 82 months
Objective Response Rate (ORR)
Time Frame: Up to approximately 82 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per PCWG-modified RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Up to approximately 82 months
Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score
Time Frame: Baseline and up to approximately 82 months
The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. The change from baseline in FACT-G total score will be reported.
Baseline and up to approximately 82 months
Time to Deterioration (TTD) in FACT-G Total Score
Time Frame: Up to approximately 82 months
The FACT-G is a HRQoL 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. TTD in FACT-G total score will be reported.
Up to approximately 82 months
Overall Improvement in FACT-G Total Score
Time Frame: Up to approximately 82 months
The FACT-G is a HRQoL 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. The overall improvement in FACT-G total score will be reported.
Up to approximately 82 months
PSA Response Rate
Time Frame: Up to approximately 82 months
The PSA response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response.
Up to approximately 82 months
Time to First Symptomatic Skeletal-Related Event (TSSRE)
Time Frame: Up to approximately 82 months
TSSRE is the time from randomization to the first symptomatic skeletal-related event defined as: 1. use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms 2. occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral) 3. occurrence of spinal cord compression 4. tumor-related orthopedic surgical intervention, whichever occurs first.
Up to approximately 82 months
Number of Participants Who Experience an AE
Time Frame: Up to approximately 82 months
An AE is defined as any unfavorable and unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE will be reported.
Up to approximately 82 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 18, 2023

Primary Completion (Estimated)

May 10, 2028

Study Completion (Estimated)

December 2, 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 27, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5684-004
  • MK-5684-004 (Other Identifier: MSD)
  • jRCT2031240030 (Registry Identifier: Japan Registry of Clinical Trial (jRCT))
  • U1111-1288-5002 (Registry Identifier: UTN)
  • 2023-504957-11-00 (Registry 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.

Clinical Trials on Prostatic Neoplasms

Clinical Trials on Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe