Prostate Cancer Clinical Trial

Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)

Summary

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses.

Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS).

Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.

View Eligibility Criteria

Eligibility Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
Has met one of the following criteria with regard to abiraterone acetate exposure: (1) is abiraterone-naïve; (2) received prior abiraterone acetate for the treatment of mHSPC or mCRPC, for a minimum of 4 weeks and not progressed while on treatment; or (3) received prior abiraterone acetate for the treatment of mHSPC or mCRPC and progressed on treatment after a minimum of 8 weeks treatment (minimum 14 weeks for those with bone progression)
Has ongoing androgen deprivation with serum testosterone <50 ngdL (<2.0 nM)
Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
Participants must agree to the following during the study treatment period and for at least 90 days after the last dose of enzalutamide: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom
Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization

Exclusion Criteria:

Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications
Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
Has an active infection (including tuberculosis) requiring systemic therapy
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
Has known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients
Has a history of seizure or any condition that may predispose to seizure
Has a history of loss of consciousness within 12 months of screening
Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure>170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit
Has bradycardia (heart rate of <50 beats per minute) on the screening electrocardiogram (ECG)
Has history of prostate cancer progression on ketoconazole
Has had prior treatment with enzalutamide, apalutamide, darolutamide or cytochrome P450 (CYP) 17 inhibitor other than abiraterone acetate
Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization
Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto) prior to randomization
Has received a live or live attenuated vaccine within 30 days prior to randomization
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has a "superscan" bone scan
Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of enzalutamide
Has had an allogenic tissue/solid organ transplant

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1240

Study ID:

NCT03834493

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 254 Locations for this study

See Locations Near You

University of South Alabama, Mitchell Cancer Institute ( Site 0065)
Mobile Alabama, 36604, United States
St. Joseph Heritage Healthcare ( Site 0069)
Fullerton California, 92835, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0081)
Los Angeles California, 90404, United States
University of Colorado Cancer Center ( Site 0022)
Aurora Colorado, 80045, United States
Smilow Cancer Hospital at Yale New Haven ( Site 0038)
New Haven Connecticut, 06513, United States
Moffitt Cancer Center ( Site 0080)
Tampa Florida, 33612, United States
Georgia Cancer Center at Augusta University ( Site 0026)
Augusta Georgia, 30912, United States
Mount Sinai Hospital Medical Center ( Site 0042)
Chicago Illinois, 60608, United States
Methodist Hospitals. ( Site 0008)
Merrillville Indiana, 46410, United States
Tulane Cancer Center ( Site 0066)
New Orleans Louisiana, 70112, United States
University of Massachusetts Worcester ( Site 0053)
Worcester Massachusetts, 01655, United States
Cancer & Hematology Centers of Western Michigan ( Site 0013)
Grand Rapids Michigan, 49503, United States
Munson Medical Center ( Site 0030)
Traverse City Michigan, 49684, United States
St. Vincent Frontier Cancer Center ( Site 0016)
Billings Montana, 59102, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0034)
Omaha Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada ( Site 0092)
Las Vegas Nevada, 89169, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
Hackensack New Jersey, 07601, United States
Associated Medical Professionals of NY ( Site 0060)
Syracuse New York, 13210, United States
W. G. Bill Hefner VA Medical Center ( Site 0029)
Salisbury North Carolina, 28144, United States
Gabrail Cancer Center-Research ( Site 0096)
Canton Ohio, 44718, United States
Tri-State Urologic Services PSC, Inc. ( Site 0094)
Cincinnati Ohio, 45212, United States
University Hospitals Cleveland Medical Center ( Site 0036)
Cleveland Ohio, 44106, United States
Oregon Health Sciences University ( Site 0031)
Portland Oregon, 97239, United States
Carolina Urologic Research Center ( Site 0070)
Myrtle Beach South Carolina, 29572, United States
Inova Schar Cancer Institute ( Site 0006)
Fairfax Virginia, 22031, United States
Virginia Cancer Institute ( Site 0052)
Richmond Virginia, 23230, United States
Blue Ridge Cancer Care ( Site 0086)
Roanoke Virginia, 24014, United States
Froedtert Hospital & the Medical College of Wisconsin ( Site 0045)
Milwaukee Wisconsin, 53226, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)
Berazategui Buenos Aires, B1884, Argentina
Instituto de Investigaciones Clinicas ( Site 1000)
Mar del Plata Buenos Aires, B7600, Argentina
Centro de Diagnostico Urologico ( Site 1008)
Buenos Aires Caba, C1120, Argentina
Instituto Medico Alexander Fleming ( Site 1010)
Buenos Aires Caba, , Argentina
Sanatorio Parque ( Site 1002)
Rosario Santa Fe, S2000, Argentina
Instituto de Oncologia de Rosario ( Site 1015)
Rosario Santa Fe, S2000, Argentina
Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)
Buenos Aires , C1012, Argentina
Hospital Aleman ( Site 1004)
Buenos Aires , C1118, Argentina
Centro Medico Dra De Salvo ( Site 1018)
Buenos Aires , C1426, Argentina
CEMAIC ( Site 1014)
Cordoba , X5008, Argentina
Centro Oncologico Riojano Integral ( Site 1005)
La Rioja , F5300, Argentina
Centro Oncologico de Integracion Regional. COIR ( Site 1007)
Mendoza , M5500, Argentina
St. Vincent's Hospital ( Site 0158)
Darlinghurst New South Wales, 2010, Australia
St George Hospital ( Site 0157)
Kogarah New South Wales, 2217, Australia
Macquarie University ( Site 0151)
Macquarie University New South Wales, 2109, Australia
Port Macquarie Base Hospital ( Site 0153)
Port Macquarie New South Wales, 2444, Australia
Calvary Mater Newcastle ( Site 0148)
Waratah New South Wales, 2298, Australia
Gallipoli Medical Research Foundation ( Site 0149)
Greenslopes Queensland, 4120, Australia
Gold Coast University Hospital ( Site 0150)
Southport Queensland, 4215, Australia
Royal Adelaide Hospital ( Site 0154)
Adelaide South Australia, 5000, Australia
Monash Health-Monash Medical Centre ( Site 0147)
Clayton Victoria, 3168, Australia
Fiona Stanley Hospital ( Site 0162)
Perth Western Australia, 6150, Australia
Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
Linz Oberosterreich, 4020, Austria
Medizinische Universität Wien ( Site 0375)
Wien , 1090, Austria
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1036)
Curitiba Parana, 81520, Brazil
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1032)
Natal Rio Grande Do Norte, 59075, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1038)
Ijui Rio Grande Do Sul, 98700, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)
Itajai Santa Catarina, 88301, Brazil
Hospital de Base de Sao Jose de Rio Preto ( Site 1022)
Sao Jose do Rio Preto Sao Paulo, 15090, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1040)
São Paulo Sao Paulo, 04014, Brazil
A.C. Camargo Cancer Center ( Site 1026)
Sao Paulo , 01509, Brazil
MHAT Serdika-Second Department of Medical Oncology ( Site 0505)
Sofia Sofia (stolitsa), 1301, Bulgaria
MHAT Central Hospital ( Site 0503)
Plovdiv , 4000, Bulgaria
Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0507)
Plovdiv , 4004, Bulgaria
BC Cancer - Victoria ( Site 0111)
Victoria British Columbia, V8R 6, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)
Hamilton Ontario, L8V5C, Canada
Grand River Hospital ( Site 0120)
Kitchener Ontario, N2G 1, Canada
Lakeridge Health ( Site 0117)
Oshawa Ontario, L1G 2, Canada
Health Sciences North ( Site 0122)
Sudbury Ontario, P3E 5, Canada
Sunnybrook Research Institute ( Site 0108)
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Centre ( Site 0107)
Toronto Ontario, M5G 2, Canada
CISSS de la Monteregie-Centre ( Site 0119)
Greenfield Park Quebec, J4V 2, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)
Montreal Quebec, H2X 0, Canada
CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)
Rimouski Quebec, G5L 5, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)
Sherbrooke Quebec, J1H 5, Canada
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)
Quebec , G1R 2, Canada
Centro Investigación del Cáncer James Lind ( Site 1041)
Temuco Araucania, 47800, Chile
Rey y Oreilly Limitada ( Site 1048)
Temuco Araucania, 48101, Chile
Fundacion Arturo Lopez Perez ( Site 1049)
Santiago Region M. De Santiago, 75009, Chile
Pontificia Universidad Catolica de Chile ( Site 1047)
Santiago Region M. De Santiago, 83300, Chile
Bradfordhill ( Site 1044)
Santiago Region M. De Santiago, 84203, Chile
Oncocentro ( Site 1045)
Vina del Mar Valparaiso, 25205, Chile
Hospital Pablo Tobon Uribe ( Site 1066)
Medellin Antioquia, 05003, Colombia
Biomelab S A S ( Site 1067)
Barranquilla Atlantico, 08000, Colombia
Clinica de la Costa Ltda. ( Site 1073)
Barranquilla Atlantico, 08002, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)
Valledupar Cesar, 20000, Colombia
Oncomedica S.A. ( Site 1057)
Monteria Cordoba, 23000, Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)
Bogota Distrito Capital De Bogota, 11132, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 1064)
Cali Valle Del Cauca, 76004, Colombia
Hemato Oncologos S.A. ( Site 1065)
Cali Valle Del Cauca, 76004, Colombia
Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 1303)
Brno Brno-mesto, 656 9, Czechia
Nemocnice AGEL Novy Jicin a.s. ( Site 1304)
Nový Jičín Novy Jicin, 741 0, Czechia
Fakultni nemocnice Olomouc ( Site 1301)
Olomouc , 779 0, Czechia
C.H. de Saint Quentin ( Site 0481)
Saint Quentin Aisne, 02321, France
Clinique Sainte Anne ( Site 0431)
Strasbourg Alsace, 67000, France
Centre Jean Perrin ( Site 0434)
Clermont-Ferrand Auvergne, 63011, France
CHU de Brest -Site Hopital Morvan ( Site 0441)
Brest Bretagne, 29200, France
CHU Jean Minjoz ( Site 0423)
Besancon Doubs, 25000, France
Institut Bergonie ( Site 0421)
Bordeaux Gironde, 33076, France
Institut Claudius Regaud IUCT Oncopole ( Site 0418)
Toulouse Haute-Garonne, 31059, France
Hopital Foch ( Site 0428)
Suresnes Hauts-de-Seine, 92150, France
Institut Regional du Cancer de Montpellier - ICM ( Site 0443)
Montpellier Herault, 34298, France
Institut De Cancerologie De L Ouest ( Site 0448)
Saint Herblain Loire-Atlantique, 44805, France
Centre Hospitalier Regional du Orleans ( Site 0430)
Orleans Loiret, 45100, France
Centre D Oncologie de Gentilly ( Site 0432)
Nancy Meurthe-et-Moselle, 54100, France
Centre Hospitalier de Valenciennes ( Site 0439)
Valenciennes Nord, 59300, France
C.H.U. Lyon Sud ( Site 0436)
Pierre Benite Rhone, 69310, France
CHU Amiens Picardie Site Sud Amiens ( Site 0438)
Amiens Somme, 80000, France
Institut Gustave Roussy ( Site 0416)
Villejuif Val-de-Marne, 94800, France
Institut Sainte Catherine ( Site 0447)
Avignon Vaucluse, 84000, France
Institut Mutualiste Montsouris ( Site 0446)
Paris , 75014, France
Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)
Freiburg Baden-Wurttemberg, 79106, Germany
Studienpraxis Urologie ( Site 0309)
Nuertingen Baden-Wurttemberg, 72622, Germany
Universitaetsklinik fuer Urologie ( Site 0307)
Tuebingen Baden-Wurttemberg, 72076, Germany
Klinikum Rechts der Isar ( Site 0300)
Muenchen Bayern, 81675, Germany
Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)
Nuernberg Bayern, 90419, Germany
Universitaetsklinikum Goettingen ( Site 0345)
Goettingen Niedersachsen, 37075, Germany
Uniklinik RWTH Aachen ( Site 0308)
Aachen Nordrhein-Westfalen, 52074, Germany
Universitaetsklinikum Muenster ( Site 0320)
Muenster Nordrhein-Westfalen, 48149, Germany
Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)
Trier Rheinland-Pfalz, 54292, Germany
Universitaetsklinikum des Saarlandes ( Site 0348)
Homburg Saarland, 66421, Germany
Universitaetsklinikum Schleswig Holstein. ( Site 0346)
Luebeck Schleswig-Holstein, 23538, Germany
Universitaetsklinikum Jena ( Site 0305)
Jena Thuringen, 07747, Germany
Charite Universitaetsmedizin Berlin ( Site 0301)
Berlin , 10117, Germany
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1321)
Kecskemét Bacs-Kiskun, 6000, Hungary
Petz Aladár Megyei Oktató Kórház-Onkológiai Osztály ( Site 1324)
Gyor Gyor-Moson-Sopron, 9024, Hungary
Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 1325)
Budapest Pest, 1122, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 1326)
Budapest , 1062, Hungary
Beaumont Hospital ( Site 0726)
Dublin , D09 V, Ireland
Tallaght University Hospital ( Site 0730)
Dublin , D24 N, Ireland
Mid Western Cancer Centre ( Site 0728)
Limerick , V94 Y, Ireland
HaEmek Medical Center ( Site 0548)
Afula , 18341, Israel
Assuta Ashdod Medical Center ( Site 0550)
Ashdod , 77476, Israel
Soroka Medical Center ( Site 0549)
Beer Sheva , 84101, Israel
Rambam Health Care Campus-Oncology Division ( Site 0543)
Haifa , 31096, Israel
Hadassah Ein Kerem Medical Center ( Site 0546)
Jerusalem , 91120, Israel
Meir Medical Center ( Site 0544)
Kfar Saba , 44281, Israel
Rabin Medical Center ( Site 0545)
Petach-Tikwa , 49414, Israel
Chaim Sheba Medical Center ( Site 0541)
Ramat Gan , 52620, Israel
Sourasky Medical Center ( Site 0542)
Tel Aviv , 64239, Israel
Yitzhak Shamir Medical Center ( Site 0547)
Zerifin , 70300, Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 0464)
Meldola Emilia-Romagna, 47014, Italy
Istituto Clinico Humanitas Research Hospital ( Site 0452)
Rozzano Lombardia, 20089, Italy
Presidio Ospedaliero S. Maria Delle Grazie-U.O.C. ONCOLOGIA ( Site 0802)
Pozzuoli Napoli, 80078, Italy
Centro Di Riferimento Oncologico ( Site 0800)
Aviano Pordenone, 33081, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0465)
Verona Veneto, 37134, Italy
Medical Oncology Ospedale San Donato ( Site 0461)
Arezzo , 52100, Italy
Ospedale Policlinico S. Orsola-Malpighi ( Site 0453)
Bologna , 40138, Italy
Azienda Ospedaliera Cannizzaro ( Site 0458)
Catania , 95126, Italy
A.O. Universitaria di Modena ( Site 0454)
Modena , 41124, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0462)
Napoli , 80131, Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
Roma , 00152, Italy
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0801)
Roma , 00168, Italy
Azienda Ospedaliera Santa Maria Terni ( Site 0456)
Terni , 05100, Italy
Az. Osp. Univ. Sta Maria della Misericordia di Udine ( Site 0460)
Udine , 33100, Italy
National Cancer Center Hospital East ( Site 0702)
Kashiwa Chiba, 277-8, Japan
Toho University Sakura Medical Center ( Site 0703)
Sakura Chiba, 285-8, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0716)
Matsuyama Ehime, 791-0, Japan
Iizuka Hospital ( Site 0744)
Iizuka Fukuoka, 820-8, Japan
Hakodate Goryoukaku Hospital ( Site 0739)
Hakodate Hokkaido, 040-8, Japan
Kanazawa University Hospital ( Site 0701)
Kanazawa Ishikawa, 920-8, Japan
Kitasato University Hospital ( Site 0705)
Sagamihara Kanagawa, 252-0, Japan
Yokohama City University Medical Center ( Site 0706)
Yokohama Kanagawa, 232-0, Japan
Miyagi Cancer Center ( Site 0747)
Natori Miyagi, 981-1, Japan
Nara Medical University Hospital ( Site 0715)
Kashihara Nara, 634-8, Japan
Kindai University Hospital ( Site 0714)
Osakasayama Osaka, 589-8, Japan
Osaka University Hospital ( Site 0713)
Suita Osaka, 565-0, Japan
Saitama Medical University International Medical Center ( Site 0708)
Hidaka Saitama, 350-1, Japan
Saitama Medical Center ( Site 0743)
Kawagoe Saitama, 350-8, Japan
Dokkyo Medical University Saitama Medical Center ( Site 0707)
Koshigaya Saitama, 343-8, Japan
Hamamatsu University Hospital ( Site 0720)
Hamamatsu Shizuoka, 431-3, Japan
Yamaguchi University Hospital ( Site 0717)
Ube Yamaguchi, 755-8, Japan
Chiba Cancer Center ( Site 0704)
Chiba , 260-8, Japan
Kyushu University Hospital ( Site 0718)
Fukuoka , 812-8, Japan
Hiroshima Prefectural Hospital ( Site 0748)
Hiroshima , 734-8, Japan
University of Miyazaki Hospital ( Site 0721)
Miyazaki , 889-1, Japan
Nagasaki University Hospital ( Site 0719)
Nagasaki , 852-8, Japan
Toranomon Hospital ( Site 0711)
Tokyo , 105-8, Japan
Nippon Medical School Hospital ( Site 0709)
Tokyo , 113-8, Japan
Keio University Hospital ( Site 0710)
Tokyo , 160-8, Japan
National Cancer Center ( Site 0174)
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0175)
Seongnam-si Kyonggi-do, 13620, Korea, Republic of
Asan Medical Center ( Site 0176)
Songpagu Seoul, 05505, Korea, Republic of
Seoul National University Hospital ( Site 0171)
Seoul , 03080, Korea, Republic of
Samsung Medical Center ( Site 0172)
Seoul , 06351, Korea, Republic of
Radboud University Medical Center ( Site 0470)
Nijmegen Gelderland, 6525 , Netherlands
Maastricht University Medical Centre ( Site 0467)
Maastricht Limburg, 6202A, Netherlands
Amphia Hospital Location Molengracht ( Site 0474)
Breda Noord-Brabant, 4818 , Netherlands
Catharina Ziekenhuis ( Site 0472)
Eindhoven Noord-Brabant, 5623 , Netherlands
Noordwest Ziekenhuisgroep NWZ ( Site 0468)
Alkmaar Noord-Holland, 1815 , Netherlands
Vrije Universiteit Medisch Centrum ( Site 0479)
Amsterdam Noord-Holland, 1081 , Netherlands
Tergooiziekenhuizen ( Site 0466)
Hilversum Noord-Holland, 1213 , Netherlands
Spaarne Ziekenhuis ( Site 0473)
Hoofddorp Noord-Holland, 2134T, Netherlands
Ziekenhuisgroep Twente ( Site 0469)
Hengelo Overijssel, 7555 , Netherlands
Haaglanden MC - locatie Antoniushove ( Site 0471)
Leidschendam Zuid-Holland, 2262 , Netherlands
Franciscus Gasthuis en Vlietland ( Site 0489)
Schiedam Zuid-Holland, 3118 , Netherlands
Tauranga Hospital ( Site 0215)
Tauranga Bay Of Plenty, 3112, New Zealand
Canterbury Regional Cancer & Blood Service ( Site 0195)
Christchurch Canterbury, 8011, New Zealand
Auckland City Hospital ( Site 0193)
Auckland , 1023, New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636)
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Salve Medica SP ( Site 0686)
Lodz Lodzkie, 91-21, Poland
Provita Prolife Centrum Medyczne ( Site 0630)
Tomaszow Mazowiecki Lodzkie, 97-20, Poland
Clinical Best Solutions ( Site 0622)
Warszawa Mazowieckie, 02-79, Poland
Przychodnia Lekarska Komed ( Site 0628)
Konin Wielkopolskie, 62-50, Poland
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624)
Koszalin Zachodniopomorskie, 75-58, Poland
Puerto Rico Medical Research Center LLC ( Site 1122)
San Juan , 00918, Puerto Rico
Fundacion de Investigacion de Diego ( Site 1121)
San Juan , 00927, Puerto Rico
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)
Chelyabinsk Chelyabinskaya Oblast, 45408, Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
Russian Scientific Center of Roentgenoradiology ( Site 0559)
Moscow Moskva, 11748, Russian Federation
Central Clinical Hospital with Polyclinic ( Site 0562)
Moscow Moskva, 12135, Russian Federation
Omsk Clinical Oncology Dispensary ( Site 0568)
Omsk Omskaya Oblast, 64401, Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)
Samara Samarskaya Oblast, 44303, Russian Federation
SBHI Leningrad Regional Oncology Dispensary ( Site 0588)
Saint Petersburg Sankt-Peterburg, 19110, Russian Federation
Clinical Research Center of specialized types medical care-Oncology ( Site 0570)
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)
Tomsk Tomskaya Oblast, 63405, Russian Federation
Instituto Catalan de Oncologia - ICO ( Site 0330)
L Hospitalet De Llobregat Barcelona, 08908, Spain
Hospital Parc Tauli ( Site 0335)
Sabadell Barcelona, 08208, Spain
Hospital Josep Trueta ( Site 0321)
Girona Gerona, 17007, Spain
Hospital Quiron Madrid ( Site 0325)
Pozuelo de Alarcon Madrid, 28223, Spain
Instituto Valenciano de Oncologia ( Site 0331)
Valencia Valenciana, Comunitat, 46009, Spain
Hospital del Mar ( Site 0333)
Barcelona , 08003, Spain
Hospital Provincial San Pedro Alcantara ( Site 0326)
Caceres , 10003, Spain
Hospital Universitario Gregorio Maranon ( Site 0327)
Madrid , 28007, Spain
MD Anderson Cancer Center Madrid ( Site 0332)
Madrid , 28033, Spain
Hospital Clinico San Carlos ( Site 0324)
Madrid , 28040, Spain
Hospital Universitario HM Sanchinarro ( Site 0322)
Madrid , 28050, Spain
Hospital Universitario Virgen de la Victoria ( Site 0337)
Malaga , 29016, Spain
Hospital Virgen del Rocio ( Site 0329)
Sevilla , 41013, Spain
National Cheng Kung University Hospital ( Site 0134)
Tainen Tainan, 704, Taiwan
China Medical University Hospital ( Site 0132)
Taichung , 40447, Taiwan
Taichung Veterans General Hospital ( Site 0133)
Taichung , 407, Taiwan
National Taiwan University Hospital ( Site 0131)
Taipei , 10048, Taiwan
Taipei Veterans General Hospital ( Site 0135)
Taipei , 112, Taiwan
Ege University Medicine of Faculty ( Site 0661)
Bornova Izmir, 35100, Turkey
Baskent University Dr. Turgut Noyan Research and Training Center-ONCCOLOGY ( Site 0618)
Adana , 01250, Turkey
Ankara University Hospital Cebeci ( Site 0613)
Ankara , 06100, Turkey
Hacettepe Universitesi-oncology hospital ( Site 0615)
Ankara , 06230, Turkey
Ankara City Hospital-Medical Oncology ( Site 0616)
Ankara , 06800, Turkey
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (
Istanbul , 34440, Turkey
Acıbadem Maslak Hastanesi ( Site 0660)
İstanbul , 34457, Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0619)
Istanbul , 34722, Turkey
Cherkasy Regional Oncology Dispensary ( Site 1203)
Cherkassy Cherkaska Oblast, 18009, Ukraine
Dnepropetrovsk Regional Clinical Oncology Hospital-Clinical oncological dispensary ( Site 1201)
Dnipropetrovsk Dnipropetrovska Oblast, 49055, Ukraine
Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 1205)
Dnipro Dnipropetrovska Oblast, 49005, Ukraine
Ivano-Frankivsk Regional Hospital-Urology department ( Site 1208)
Ivano-Frankivsk Ivano-Frankivska Oblast, 76008, Ukraine
Communal Non-Commercial Enterprise ""Prykarpatski Clinical Oncological Center"" of Ivano-Frankivsk R
Ivano-Frankivsk Ivano-Frankivska Oblast, 76018, Ukraine
CNPE Regional Center of Oncology-oncourology department ( Site 1202)
Kharkiv Kharkivska Oblast, 61070, Ukraine
LISOD - Israeli Oncological Hospital ""MedX-ray Internationa-Department of Clinical and Scientific (
Kiev Kyivska Oblast, 08720, Ukraine
Municipal non-profit enterprise Kyiv City Clinical Oncology -Oncourology department ( Site 1204)
Kyiv Kyivska Oblast, 03115, Ukraine
University Hospitals Bristol NHS Foundation Trust ( Site 0530)
Bristol Bristol, City Of, BS2 8, United Kingdom
Cambridge University Hospitals NHS Trust ( Site 0540)
Cambridge Cambridgeshire, CB2 0, United Kingdom
Torbay Hospital ( Site 0532)
Torquay Devon, TQ2 7, United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 0482)
London London, City Of, NW1 2, United Kingdom
Musgrove Park Hospital ( Site 0537)
Taunton Somerset, TA1 5, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 0526)
London Sutton, SM2 5, United Kingdom
Western General Hospital ( Site 0531)
Edinburgh Worcestershire, EH42X, United Kingdom
Mount Vernon Cancer Centre ( Site 0536)
Northwood , HA6 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1240

Study ID:

NCT03834493

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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