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NCT06136650PHASE3Recruiting

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)

Merck Sharp & Dohme LLC

Start Date

12/18/2023

Completion Date

12/2/2030

Summary

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

Detailed Description

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

Eligibility Criteria

Age Range: 18 years to No maximum

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 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

Interventions

DRUG

Opevesostat

DRUG

Dexamethasone

DRUG

Fludrocortisone acetate

DRUG

Hydrocortisone

DRUG

Abiraterone acetate

DRUG

Prednisone acetate

DRUG

Enzalutamide

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Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)Prostatic Neoplasms

Locations

The University of Arizona Cancer Center - North Campus ( Site 0073)

Tucson, Arizona 85719

United States

UCLA Hematology/Oncology - Santa Monica ( Site 0044)

Los Angeles, California 90404

United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)

Orange, California 92868

United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120)

Orange, California 92868

United States

Stanford Cancer Center ( Site 0036)

Palo Alto, California 94304

United States

Emad Ibrahim,MD,INC. ( Site 0012)

Redlands, California 92373

United States

Kaiser Permanente Riverside Medical Center ( Site 0099)

Riverside, California 92505

United States

University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114)

Sacramento, California 95817

United States

San Francisco VA Health Care System ( Site 0093)

San Francisco, California 94121

United States

Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)

Vallejo, California 94589

United States

University of Colorado Anschutz Medical Campus ( Site 0046)

Aurora, Colorado 80045

United States

UCHealth Highlands Ranch Hospital ( Site 0111)

Highlands Ranch, Colorado 80129

United States

Colorado Clinical Research ( Site 0067)

Lakewood, Colorado 80228

United States

University of Colorado Health - Lone Tree Medical Center ( Site 0112)

Lone Tree, Colorado 80124

United States

Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)

New Haven, Connecticut 06510

United States

MedStar Washington Hospital Center ( Site 0103)

Washington D.C., District of Columbia 20010

United States

Florida Cancer Specialists - South ( Site 7003)

Fort Myers, Florida 33901

United States

Mount Sinai Cancer Center ( Site 0107)

Miami Beach, Florida 33140

United States

Memorial Hospital West-Memorial Cancer Institute ( Site 0109)

Pembroke Pines, Florida 33028

United States

Northside Hospital-Northside Hospital Oncology Network ( Site 0100)

Atlanta, Georgia 30342

United States

Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074)

Elmhurst, Illinois 60126

United States

Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075)

Naperville, Illinois 60540

United States

Illinois Cancer Care ( Site 0104)

Peoria, Illinois 61615

United States

Urology of Indiana - Carmel ( Site 0055)

Carmel, Indiana 46032

United States

University of Kentucky Chandler Medical Center ( Site 0048)

Lexington, Kentucky 40536

United States

Baltimore Veterans Affairs Medical Center ( Site 0069)

Baltimore, Maryland 21201

United States

Greenebaum Comprehensive Cancer Center ( Site 0049)

Baltimore, Maryland 21201

United States

Chesapeake Urology ( Site 0009)

Towson, Maryland 21204

United States

Henry Ford Hospital ( Site 0015)

Detroit, Michigan 48202

United States

Cancer and Hematology Centers of Western Michigan ( Site 0005)

Grand Rapids, Michigan 49503

United States

Avera Cancer Institute - Marshall (Site 0122)

Marshall, Minnesota 56258

United States

HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072)

Saint Louis Park, Minnesota 55426

United States

HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092)

Saint Paul, Minnesota 55101

United States

St. Vincent Frontier Cancer Center-Research ( Site 0037)

Billings, Montana 59102

United States

Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)

Omaha, Nebraska 68130

United States

OptumCare Cancer Care-Research Department ( Site 0078)

Las Vegas, Nevada 89102

United States

Comprehensive Cancer Centers of Nevada ( Site 0010)

Las Vegas, Nevada 89148

United States

Rutgers Cancer Institute of New Jersey ( Site 0033)

New Brunswick, New Jersey 08901

United States

Associated Medical Professionals - Urology ( Site 0081)

Syracuse, New York 13210

United States

University Hospitals Cleveland Medical Center ( Site 0043)

Cleveland, Ohio 44106

United States

Central Ohio Urology Group - Gahanna ( Site 0098)

Gahanna, Ohio 43230

United States

Genesis Healthcare System ( Site 0102)

Zanesville, Ohio 43701

United States

MidLantic urology ( Site 0022)

Bala-Cynwyd, Pennsylvania 19004

United States

Fox Chase Cancer Center ( Site 0076)

Philadelphia, Pennsylvania 19111

United States

Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)

Charleston, South Carolina 29401

United States

Avera Cancer Institute - Aberdeen (Site 0123)

Aberdeen, South Dakota 57401

United States

Avera Cancer Institute - Mitchell (Site 0121)

Mitchell, South Dakota 57301

United States

Avera Cancer Institute - Pierre ( Site 0118)

Pierre, South Dakota 57501

United States

Avera Cancer Institute- Research ( Site 0094)

Sioux Falls, South Dakota 57105

United States

Avera Cancer Institute - Yankton ( Site 0117)

Yankton, South Dakota 57078

United States

The West Clinic, PLLC dba West Cancer Center ( Site 0063)

Germantown, Tennessee 38138

United States

Texas Oncology - Central/South Texas ( Site 8003)

Austin, Texas 78731

United States

Texas Oncology - DFW ( Site 8001)

Dallas, Texas 75246

United States

Texas Oncology - Gulf Coast ( Site 8002)

Houston, Texas 77024

United States

University of Virginia Health System ( Site 0054)

Charlottesville, Virginia 22908

United States

Inova Schar Cancer Institute ( Site 0017)

Fairfax, Virginia 22031

United States

Virginia Cancer Specialists (VCS) ( Site 8004)

Fairfax, Virginia 22031

United States

VCU Health Adult Outpatient Pavillion ( Site 0061)

Richmond, Virginia 23219

United States

Blue Ridge Cancer Care ( Site 0004)

Roanoke, Virginia 24014

United States

Spokane Urology ( Site 0035)

Spokane, Washington 99202

United States

Northwest Cancer Specialists (Compass Oncology) ( Site 8008)

Vancouver, Washington 98684

United States

MEDICAL COLLEGE OF WISCONSIN ( Site 0020)

Milwaukee, Wisconsin 53226

United States

Macquarie University-MQ Health Clinical Trials Unit ( Site 0214)

Macquarie University, New South Wales 2109

Australia

Westmead Hospital ( Site 0212)

Westmead, New South Wales 2145

Australia

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0211)

Brisbane, Queensland 4029

Australia

Monash Health ( Site 0219)

Clayton, Victoria 3168

Australia

Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210)

Melbourne, Victoria 3000

Australia

CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0256)

Fortaleza, Ceará 60336-232

Brazil

Hospital Santa Rita de Cassia ( Site 0271)

Vitória, Espírito Santo 29043-260

Brazil

Obras Sociais Irma Dulce ( Site 0255)

Salvador, Estado de Bahia 40415-006

Brazil

Hospital São Domingos ( Site 0258)

São Luís, Maranhão 65060-645

Brazil

Hospital Mario Penna ( Site 0264)

Belo Horizonte, Minas Gerais 30380-472

Brazil

Universidade Federal do Triangulo Mineiro - Hospital de Clinicas ( Site 0262)

Uberaba, Minas Gerais 38025-350

Brazil

ICTRIALS Pesquisa e Desenvolvimento ( Site 0274)

Curitiba, Paraná 80510-130

Brazil

Hospital Universitário Evangélico Mackenzie ( Site 0252)

Curitiba, Paraná 80730-150

Brazil

Hospital São Lucas da PUCRS ( Site 0270)

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Clínica de Neoplasias Litoral ( Site 0269)

Itajaí, Santa Catarina 88301-220

Brazil

Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0251)

Bragança Paulista, São Paulo 12916-542

Brazil

Hospital de Base de São José do Rio Preto ( Site 0275)

São José do Rio Preto, São Paulo 15090-000

Brazil

Instituto do Câncer Brasil - Unidade Taubaté ( Site 0263)

Taubaté, São Paulo 12030-200

Brazil

Hospital Paulistano ( Site 0259)

São Paulo, 01321-001

Brazil

Cross Cancer Institute (Site 0281)

Edmonton, Alberta T6G 1Z2

Canada

BC Cancer Abbotsford-Clinical Trials Unit (Site 0287)

Abbotsford British Columbia, British Columbia V2S 0C2

Canada

Trillium Health Partners - Credit Valley Hospital ( Site 0289)

Mississauga, Ontario L5M 2N1

Canada

The Ottawa Hospital - General Campus ( Site 0286)

Ottawa, Ontario K1H 8L6

Canada

Sunnybrook Research Institute ( Site 0285)

Toronto, Ontario M4N 3M5

Canada

Centre Hospitalier de l'Université de Montréal ( Site 0276)

Montreal, Quebec H2X 3E4

Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0277)

Québec, Quebec G1J 1Z4

Canada

CIDO SpA-Oncology ( Site 0302)

Temuco, Araucania 4810218

Chile

Clinica Universidad Catolica del Maule-Oncology ( Site 0306)

Talca, Maule Region 3465584

Chile

FALP ( Site 0303)

Santiago, Region M. de Santiago 7500921

Chile

Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0304)

Santiago, Region M. de Santiago 8330024

Chile

Bradfordhill-Clinical Area ( Site 0301)

Santiago, Region M. de Santiago 8420383

Chile

ONCOCENTRO APYS-ACEREY ( Site 0305)

Viña del Mar, Valparaiso 2520598

Chile

The Second Hospital Of Anhui Medical University ( Site 1633)

Hefei, Anhui 230000

China

Peking University First Hospital-Urology ( Site 1602)

Beijing, Beijing Municipality 100034

China

Beijing Cancer hospital-Urinary Surgery ( Site 1620)

Beijing, Beijing Municipality 100142

China

First Medical Center of Chinese PLA General Hospital ( Site 1601)

Beijing, Beijing Municipality 100853

China

Beijing Cancer Hospital ( Site 1623)

Beijing, Beijing Municipality 130021

China

Chongqing University Cancer Hospital ( Site 1603)

Chongqing, Chongqing Municipality 400030

China

Southwest Hospital of Third Military Medical University ( Site 1645)

Chongqing, Chongqing Municipality 400038

China

The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 1639)

Fuzhou, Fujian 350005

China

The first affiliated hospital of Guangzhou medical university ( Site 1637)

Guangzhou, Guangdong 510030

China

Sun Yat-sen University Cancer Center-Urology Surgery ( Site 1638)

Guangzhou, Guangdong 510700

China

Tongji Hospital Tongji Medical,Science & Technology ( Site 1632)

Wuhan, Hubei 430000

China

The Central Hospital of Wuhan ( Site 1635)

Wuhan, Hubei 430014

China

Hubei Cancer Hospital-Urinary surgery ( Site 1631)

Wuhan, Hubei 430079

China

Hunan Cancer Hospital ( Site 1630)

Changsha, Hunan 410013

China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1615)

Nanjing, Jiangsu 210008

China

Nantong Tumor Hospital-Urology ( Site 1609)

Nantong, Jiangsu 226361

China

Wuxi People's Hospital ( Site 1612)

Wuxi, Jiangsu 214023

China

The Second Affiliated Hospital of Xi'an Jiaotong University-Oncology Department ( Site 1619)

Xi'an, Shaanxi 710004

China

The First Affiliated Hospital of Xi'an Jiaotong University-Oncology department ( Site 1618)

Xi'an, Shaanxi 710061

China

Yantai Yuhuangding Hospital ( Site 1622)

Yantai, Shandong 264099

China

Renji Hosp Shanghai Jiaotong U School of Med ( Site 1624)

Shanghai, Shanghai Municipality 200001

China

Huadong Hospital Affiliated to Fudan University-Urology ( Site 1613)

Shanghai, Shanghai Municipality 200041

China

West China Hospital, Sichuan University-Urology Surgery ( Site 1642)

Chengdu, Sichuan 610041

China

Nanchong Central Hospital-urology ( Site 1647)

Nanchong, Sichuan 500643

China

The Second Hospital of Tianjin Medical University ( Site 1616)

Tianjin, Tianjin Municipality 300211

China

Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 1644)

Ürümqi, Xinjiang 830000

China

Yunnan Province Cancer Hospital ( Site 1643)

Kunming, Yunnan 650107

China

Zhejiang Provincial People's Hospital-Urology ( Site 1641)

Hangzhou, Zhejiang 310014

China

The First Hospital of Jiaxing-urology ( Site 1605)

Jiaxing, Zhejiang 314001

China

Ningbo First Hospital-Urology ( Site 1608)

Ningbo, Zhejiang 315010

China

The First Affiliated Hospital of Wenzhou Medical University ( Site 1604)

Wenzhou, Zhejiang 325015

China

Los Cobos Medical Center ( Site 0336)

Bogotá, Bogota D.C. 110121

Colombia

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0326)

Bogotá, Bogota D.C. 111321

Colombia

Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0327)

Valledupar, Cesar Department 200001

Colombia

IMAT S.A.S ( Site 0329)

Montería, Departamento de Córdoba 230002

Colombia

Fundación Cardiovascular de Colombia ( Site 0328)

Piedecuesta, Santander Department 681017

Colombia

Fundación Valle del Lili ( Site 0330)

Cali, Valle del Cauca Department 760032

Colombia

Clínica Imbanaco S.A.S ( Site 0334)

Cali, Valle del Cauca Department 760042

Colombia

CIMCA-Hemato-Oncology ( Site 0380)

San José, Provincia de San José 10103

Costa Rica

Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0379)

Santa Ana, Provincia de San José 10903

Costa Rica

Onco Tech, S.A. ( Site 0376)

San José, 10103

Costa Rica

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0403)

Brno, Brno-mesto 656 53

Czechia

Krajská nemocnice Liberec-Department of Urology ( Site 0407)

Liberec, Liberec Region 460 01

Czechia

Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0401)

Prague, Praha 5 150 06

Czechia

Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0404)

Brno, South Moravian 602 00

Czechia

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0405)

Olomouc, 77900

Czechia

Vseobecna fakultni nemocnice v Praze ( Site 0406)

Prague, 12808

Czechia

East-Tallinn Central Hospital ( Site 1528)

Tallinn, Harju 11314

Estonia

North Estonia Medical Centre Foundation ( Site 1526)

Tallinn, Harju 13419

Estonia

Pärnu Haigla (Site 1550)

Pärnu, Pärnumaa 80010

Estonia

Tartu University Hospital-Radiotherapy and oncology ( Site 1527)

Tartu, Tartu 50406

Estonia

Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0451)

Strasbourg, Alsace 67200

France

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0461)

Bordeaux, Aquitaine 33076

France

CENTRE LEON BERARD ( Site 0459)

Lyon Cedex08, Auvergne-Rhône-Alpes 69373

France

CHU-BREST Cavale Blanche ( Site 0456)

Brest, Finistere 29609

France

Ramsay Santé - Clinical La Croix Du Sud ( Site 0460)

Quint-Fonsegrives, Haute-Garonne 31130

France

Centre Bourgogne ( Site 0464)

Lille, Hauts-de-France 59000

France

Hôpital Foch ( Site 0455)

Suresnes, Hauts-de-Seine 92150

France

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0454)

Clermont-Ferrand, Puy-de-Dome 63003

France

Gustave Roussy ( Site 0452)

Villejuif, Val-de-Marne 94800

France

Sainte Catherine Institut du Cancer Avignon Provence ( Site 0458)

Avignon, Vaucluse 84000

France

Groupe Hospitalier Paris Saint Joseph ( Site 0465)

Paris, 75014

France

Universitaetsklinikum Freiburg-Klinik für Urologie ( Site 0506)

Freiburg im Breisgau, Baden-Wurttemberg 79106

Germany

Universitaetsklinikum Heidelberg ( Site 0531)

Heidelberg, Baden-Wurttemberg 69120

Germany

Studienpraxis Urologie ( Site 0529)

Nürtingen, Baden-Wurttemberg 72622

Germany

klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0521)

Munich, Bavaria 81675

Germany

Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0523)

Regensburg, Bavaria 93053

Germany

Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 0510)

Marburg, Hesse 35043

Germany

Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Urologie ( Site 0527)

Göttingen, Lower Saxony 37075

Germany

Marien-Krankenhaus ( Site 0515)

Bergisch Gladbach, North Rhine-Westphalia 51465

Germany

Universitaetsklinikum Koeln ( Site 0518)

Cologne, North Rhine-Westphalia 50937

Germany

Urologicum Duisburg (Site 00538)

Duisburg, North Rhine-Westphalia 47169

Germany

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0528)

Dresden, Saxony 01307

Germany

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)

Berlin, 10117

Germany

Vivantes Klinikum Am Urban ( Site 0512)

Berlin, 10967

Germany

UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0553)

Pátrai, Achaia 26504

Greece

Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0551)

Athens, Attica 115 28

Greece

ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Site 0552)

Chaïdári, Attica 124 62

Greece

MEDI-K ( Site 0576)

Guatemala City, 01009

Guatemala

CELAN,S.A ( Site 0579)

Guatemala City, 01010

Guatemala

INTEGRA Cancer Institute-Oncology ( Site 0578)

Guatemala City, 01010

Guatemala

Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0577)

Guatemala City, 01010

Guatemala

Sanatorio Nuestra Senora del Pilar ( Site 0580)

Guatemala City, 01015

Guatemala

Hong Kong Integrated Oncology Centre ( Site 0603)

Central, 999077

Hong Kong

Queen Mary Hospital ( Site 0602)

Hong Kong,

Hong Kong

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C ( Site 0630)

Miskolc, Borsod-Abauj Zemplen county 3526

Hungary

Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0636)

Salgótarján, Nógrád megye 3100

Hungary

Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0631)

Budapest, Pest County 1122

Hungary

Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0632)

Debrecen, 4032

Hungary

St. Vincent's University Hospital ( Site 0652)

Dublin, Dublin D04 T6F4

Ireland

Tallaght University Hospital ( Site 0651)

Dublin, D24 NR0A

Ireland

Emek Medical Center ( Site 0680)

Afula, 1834111

Israel

Rambam Health Care Campus-Oncology Division ( Site 0676)

Haifa, 3109601

Israel

Shaare Zedek Medical Center ( Site 0679)

Jerusalem, 9103102

Israel

Hadassah Medical Center ( Site 0683)

Jerusalem, 9112001

Israel

Meir Medical Center. ( Site 0682)

Kfar Saba, 4428164

Israel

Rabin Medical Center ( Site 0678)

Petah Tikva, 4941492

Israel

Sheba Medical Center ( Site 0677)

Ramat Gan, 5265601

Israel

Sourasky Medical Center ( Site 0681)

Tel Aviv, 6423906

Israel

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1454)

Meldola, Emilia-Romagna 47014

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1452)

Milan, Lombardy 20133

Italy

Ospedale Cannizzaro ( Site 1455)

Catania, 95126

Italy

Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 1456)

Foggia, 71100

Italy

Ospedale San Raffaele-Oncologia Medica ( Site 1451)

Milan, 20132

Italy

Azienda Ospedaliera Santa Maria Terni ( Site 1458)

Terni, 05100

Italy

Toho University Sakura Medical Center ( Site 0730)

Sakura, Chiba 285-8741

Japan

University of Fukui Hospital ( Site 0735)

Eiheiji-cho,Yoshida-gun, Fukui 910-1193

Japan

Hospital of the University of Occupational and Environmental Health, Japan ( Site 0746)

Kitakyushu, Fukuoka 807-8556

Japan

Sapporo Medical University Hospital ( Site 0726)

Sapporo, Hokkaido 060-8543

Japan

Hokkaido University Hospital ( Site 0756)

Sapporo, Hokkaido 060-8648

Japan

Kobe University Hospital ( Site 0741)

Kobe, Hyōgo 650-0017

Japan

Kanazawa Medical University Hospital ( Site 0734)

Mukai-awagasaki, Ishikawa-ken 920-0265

Japan

Kagawa University Hospital ( Site 0744)

Kita, Kagawa-ken 761-0701

Japan

Yokohama City University Medical Center ( Site 0733)

Yokohama, Kanagawa 232-0024

Japan

Mie University Hospital ( Site 0737)

Tsu, Mie-ken 514-8507

Japan

National Hospital Organization Nagasaki Medical Center ( Site 0748)

Ōmura, Nagasaki 856-8562

Japan

Nara Medical University Hospital ( Site 0742)

Kashihara, Nara 634-8522

Japan

Nanbu Tokushukai Hospital ( Site 0755)

Shimajiri, Okinawa 901-0417

Japan

Kansai Medical University Hospital ( Site 0739)

Hirakata, Osaka 573-1191

Japan

Bell Land General Hospital ( Site 0740)

Sakai, Osaka 599-8247

Japan

The University of Osaka Hospital ( Site 0738)

Suita, Osaka 565-0871

Japan

Saga-Ken Medical Centre Koseikan ( Site 0747)

Saga, Saga-ken 840-8571

Japan

Nihon University Itabashi Hospital ( Site 0732)

Itabashiku, Tokyo 173-8610

Japan

The Jikei University Hospital ( Site 0731)

Minato, Tokyo 105-8471

Japan

Akita University Hospital ( Site 0728)

Akita, 010-8543

Japan

Kyushu University Hospital ( Site 0745)

Fukuoka, 812-8582

Japan

Fukushima Medical University Hospital ( Site 0758)

Fukushima, 960-1295

Japan

Gifu University Hospital ( Site 0736)

Gifu, 501-1112

Japan

Hiroshima University Hospital ( Site 0743)

Hiroshima, 734-8551

Japan

Kagoshima University Hospital ( Site 0754)

Kagoshima, 890-8520

Japan

National Hospital Organization Kumamoto Medical Center ( Site 0749)

Kumamoto, 860-0008

Japan

Miyazaki Prefectural Miyazaki Hospital ( Site 0752)

Miyazaki, 880-8510

Japan

University of Miyazaki Hospital ( Site 0751)

Miyazaki, 889-1692

Japan

Nagano Municipal Hospital ( Site 0757)

Nagano, 381-8551

Japan

National Hospital Organization Oita Medical Center ( Site 0750)

Ōita, 870-0263

Japan

Liepaja Regional Hospital ( Site 1553)

Liepāja, LV3414

Latvia

Pauls Stradins Clinical Univeristy Hospital-Urological department ( Site 1551)

Riga, LV-1002

Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 1576)

Kaunas, Kaunas County 50161

Lithuania

National Cancer Institute ( Site 1577)

Vilnius, Vilniaus Miestas 08660

Lithuania

Hospital Sultan Ismail ( Site 0905)

Johor Bahru, Johor 81100

Malaysia

University Malaya Medical Centre ( Site 0902)

Lembah Pantai, Kuala Lumpur 59100

Malaysia

National Cancer Institute ( Site 0904)

Putrajaya, Putrajaya 62250

Malaysia

Sarawak General Hospital-Radiotherapy Unit ( Site 0901)

Kuching, Sarawak 93586

Malaysia

Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 0903)

Kuala Lumpur, 50586

Malaysia

CIO - Centro de Inmuno-Oncología de Occidente ( Site 0928)

Guadalajara, Jalisco 44630

Mexico

Health Pharma Professional Research S.A. de C.V: ( Site 0929)

Mexico City, Mexico City 03100

Mexico

Higiea Oncologia ( Site 0938)

Mexico City, Mexico City 11810

Mexico

Quemex Medical and Research ( Site 0937)

Tlalpan, Mexico City 14308

Mexico

Filios Alta Medicina ( Site 0931)

Monterrey, Nuevo León 64460

Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0932)

Monterrey, Nuevo León 64460

Mexico

Eukarya Pharmasite S.C. ( Site 0939)

Monterrey, Nuevo León 64718

Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 0934)

Oaxaca City, Oaxaca 68020

Mexico

Dunedin Hospital ( Site 1032)

Dunedin, Otago 9016

New Zealand

Auckland City Hospital ( Site 1033)

Auckland, 1023

New Zealand

Aliada-Oncologìa ( Site 1055)

Lima, 15036

Peru

IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1052)

Lima, 15036

Peru

Oncosalud-Clinical Research ( Site 1057)

Lima, 15036

Peru

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1054)

Lima, 15038

Peru

Hospital de Cascais Doutor José de Almeida ( Site 1158)

Alcabideche, Lisbon District 2755-009

Portugal

Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1156)

Vila Nova de Gaia, Porto District 4434-502

Portugal

Unidade Local de Saude de Braga - Hospital de Braga ( Site 1151)

Braga, 4710-243

Portugal

Hospital CUF - Tejo ( Site 1157)

Lisbon, 1350-352

Portugal

Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1153)

Lisbon, 1649-035

Portugal

Unidade Local de Saude de Santo António - Hospital Santo António ( Site 1152)

Porto, 4099-001

Portugal

Advance Urology and Laparoscopic Center ( Site 1178)

Ponce, 00716

Puerto Rico

Ad-Vance Medical Research-Research ( Site 1177)

Ponce, 00717

Puerto Rico

Pan American Center for Oncology Trials - Ciudadela ( Site 1176)

San Juan, 00909

Puerto Rico

Spitalul Universitar de Urgență Elias ( Site 1504)

Bucharest, Bucharest 011461

Romania

Cardiomed SRL Cluj-Napoca ( Site 1503)

Cluj-Napoca, Cluj 400015

Romania

SC Radiotherapy Center Cluj SRL ( Site 1502)

Florești, Cluj 407280

Romania

Centrul de Oncologie "Sfântul Nectarie" ( Site 1501)

Craiova, Dolj 200746

Romania

Delta Health Care SRL (Site 1507)

Bucharest, 014142

Romania

Spitalul Clinic ''Prof Dr. Theodor Burghele" (Site 1505)

Bucharest, 050659

Romania

National University Hospital ( Site 1201)

Singapore, Central Singapore 119074

Singapore

National Cancer Centre Singapore ( Site 1202)

Singapore, Central Singapore 168583

Singapore

Singapore General Hospital ( Site 1204)

Singapore, Central Singapore 169608

Singapore

Tan Tock Seng Hospital-Medical Oncology ( Site 1203)

Singapore, Central Singapore 308433

Singapore

UROEXAM ( Site 1479)

Nitra, Nitra Region 949 01

Slovakia

Privatna Urologicka Ambulancia ( Site 1478)

Trenčín, Trenčín Region 911 01

Slovakia

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1230)

Port Elizabeth, Eastern Cape 6055

South Africa

Wits Clinical Research ( Site 1234)

Johannesburg, Gauteng 2193

South Africa

Wilgers Oncology Centre ( Site 1232)

Pretoria, Gauteng 0040

South Africa

Curo Oncology. ( Site 1237)

Pretoria, Gauteng 0084

South Africa

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1236)

Pretoria, Gauteng 0181

South Africa

Cape Town Oncology Trials ( Site 1233)

Cape Town, Western Cape 7570

South Africa

National Cancer Center-Center for Urologic Cancer ( Site 1254)

Goyang-si, Kyonggi-do 10408

South Korea

Seoul National University Bundang Hospital-Urology ( Site 1253)

Seongnam, Kyonggi-do 13620

South Korea

Kyungpook National University Chilgok Hospital-Urology ( Site 1252)

Buk-gu, Kyongsangbuk-do 41404

South Korea

Pusan National University Yangsan Hospital ( Site 1256)

Pusan, Kyongsangnam-do 50612

South Korea

Seoul National University Hospital-Urology ( Site 1251)

Seoul, 03080

South Korea

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1255)

Seoul, 06591

South Korea

Hospital Universitari Parc Tauli-oncologia ( Site 1282)

Sabadell, Barcelona 08208

Spain

HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1284)

Barcelona, Catalonia 08036

Spain

Institut Català d'Oncologia (ICO) - Girona ( Site 1285)

Girona, Gerona 17007

Spain

Complexo Hospitalario Universitario A Coruna ( Site 1288)

A Coruña, La Coruna 15006

Spain

Hospital Insular de Gran Canaria-Oncology ( Site 1280)

Las Palmas de Gran Canaria, Las Palmas 35016

Spain

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1283)

Pozuelo de Alarcón, Madrid 28223

Spain

Hospital Universitario de Burgos-Oncología ( Site 1281)

Burgos, 09006

Spain

Hospital Quirón Málaga ( Site 1286)

Málaga, 29004

Spain

Karolinska Universitetssjukhuset Solna ( Site 1302)

Stockholm, Stockholm County 171 64

Sweden

Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1301)

Uppsala, Uppsala County 751 85

Sweden

Chi Mei Medical Center ( Site 1336)

Tainan, Tainan 71004

Taiwan

Kaohsiung Veterans General Hospital ( Site 1337)

Kaohsiung City, 81362

Taiwan

Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1331)

Kaohsiung City, 83301

Taiwan

China Medical University Hospital-Department of Urology ( Site 1335)

Taichung, 40447

Taiwan

Taichung Veterans General Hospital ( Site 1338)

Taichung, 40705

Taiwan

Taipei Veterans General Hospital ( Site 1332)

Taipei, 112

Taiwan

Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1334)

Taoyuan, 333

Taiwan

Chulalongkorn University ( Site 1355)

Bangkok, Bangkok 10330

Thailand

Faculty of Medicine Siriraj Hospital ( Site 1356)

Bangkok, Bangkok 10700

Thailand

Faculty of Medicine - Khon Kaen University ( Site 1351)

Muang, Changwat Khon Kaen 40002

Thailand

Songklanagarind hospital ( Site 1352)

Hat Yai, Changwat Songkhla 90110

Thailand

Maharaj Nakorn Chiang Mai Hospital ( Site 1353)

Muang, Chiang Mai 50200

Thailand

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1379)

Adana, 01250

Turkey (Türkiye)

Hacettepe Universite Hastaneleri-oncology hospital ( Site 1376)

Ankara, 06230

Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1377)

Ankara, 06800

Turkey (Türkiye)

Koc Universitesi Hastanesi ( Site 1384)

Istanbul, 34010

Turkey (Türkiye)

T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1381)

Istanbul, 34147

Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1383)

Istanbul, 34668

Turkey (Türkiye)

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1378)

Istanbul, 34722

Turkey (Türkiye)

Ege Universitesi Hastanesi-Medical Oncology ( Site 1380)

Izmir, 35100

Turkey (Türkiye)

Samsun Medical Park Hastanesi-medical oncology ( Site 1382)

Samsun, 55200

Turkey (Türkiye)

Addenbrooke's Hospital ( Site 1426)

Cambridge, Cambridgeshire CB2 2QQ

United Kingdom

Royal Derby Hospital ( Site 1431)

Derby, Derbyshire DE22 3NE

United Kingdom

Torbay Hospital ( Site 1429)

Torquay, Devon TQ2 7AA

United Kingdom

Mount Vernon Cancer Centre ( Site 1440)

Northwood, England HA6 2RN

United Kingdom

The Royal Cornwall Hospital ( Site 1430)

Truro, England TR1 3LJ

United Kingdom

The Beatson West of Scotland Cancer Centre ( Site 1428)

Glasgow, Glasgow City G12 0YN

United Kingdom

Charing Cross Hospital-Oncology Research ( Site 1434)

London, Hammersmith and Fulham W6 8RF

United Kingdom

University College London Hospital ( Site 1437)

London, London, City of NW1 2PG

United Kingdom

Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435)

London, London, City of SE1 9RT

United Kingdom

St. George's Hospital-Oncology ( Site 1441)

London, London, City of SW17 0QT

United Kingdom

GenesisCare - Oxford ( Site 1442)

Oxford, Oxfordshire OX4 6LB

United Kingdom

GenesisCare - Windsor ( Site 1443)

Windsor, Windsor And Maidenhead SL4 3HD

United Kingdom

The Christie NHS Foundation Trust ( Site 1436)

Manchester, m20 4bx

United Kingdom