Prostate Cancer Clinical Trial

Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

Summary

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).

There are two primary study hypotheses.

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

Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone 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.

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Full Description

With Amendment 6 (effective date: 29-Sep-2022), all participants will be unblinded and placebo treatment will be stopping. Participants who are deemed to be deriving clinical benefit from treatment may continue at the discretion of the investigator.

View Eligibility Criteria

Eligibility Criteria

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 screening
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 received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug
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 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
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 (non-infectious) pneumonitis that required steroids or current pneumonitis
Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs
Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization
Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
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 co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
Has hypersensitivity to docetaxel or polysorbate 80
Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent
Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
Has received a live vaccine within 30 days prior to randomization
Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization
Has received prior treatment with ketoconazole for prostate cancer
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 120 days after the last dose of study treatment
Has had an allogenic tissue/solid organ transplant

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1090

Study ID:

NCT03834506

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 210 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
University of Southern California Norris Comprehensive Cancer Center ( Site 0061)
Los Angeles California, 90033, United States
USC Norris Oncology Hematology Newport Beach ( Site 0093)
Newport Beach California, 92663, United States
University of California San Francisco ( Site 0023)
San Francisco California, 94158, United States
University of Colorado Cancer Center ( Site 0022)
Aurora Colorado, 80045, United States
Yale Cancer Center ( Site 0038)
New Haven Connecticut, 06510, 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 Hospital- Merriillville ( Site 0008)
Merrillville Indiana, 46410, United States
Karmanos Cancer Institute ( Site 0077)
Detroit Michigan, 48201, United States
Henry Ford Health System ( Site 0039)
Detroit Michigan, 48202, United States
Cancer & Hematology Centers of Western Michigan ( Site 0013)
Grand Rapids Michigan, 49503, United States
Washington University School of Medicine ( Site 0057)
Saint Louis Missouri, 63110, United States
St. Vincent Frontier Cancer Center ( Site 0016)
Billings Montana, 59102, United States
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
Duke Cancer Center ( Site 0010)
Durham North Carolina, 27710, United States
W. G. Bill Hefner VA Medical Center ( Site 0029)
Salisbury North Carolina, 28144, 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
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
Hospital Britanico de Buenos Aires ( Site 1006)
Buenos Aires Caba, C1280, Argentina
Sanatorio Parque ( Site 1002)
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
Instituto Medico Alexander Fleming ( Site 1010)
Buenos Aires , C1426, Argentina
CEMAIC ( Site 1014)
Cordoba , X5008, Argentina
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
Redcliffe Hospital ( Site 0161)
Redcliffe Queensland, 4020, Australia
John Flynn Hospital & Medical Centre ( Site 0164)
Tugun Queensland, 4224, Australia
Hollywood Private Hospital ( Site 0163)
Nedlands Western Australia, 6009, Australia
Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)
Linz Oberosterreich, 4020, Austria
Medizinische Universitat Graz ( Site 0374)
Graz Steiermark, 8036, Austria
SCRI-CCCIT GesmbH ( Site 0371)
Salzburg , 5020, Austria
Medizinische Universitaet Wien ( Site 0375)
Wien , 1090, Austria
Hospital de Caridade de Ijui ( 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
A.C. Camargo Cancer Center ( Site 1026)
Sao Paulo , 01509, Brazil
Nova Scotia Health Authority QEII-HSC ( Site 0114)
Halifax Nova Scotia, B3H 2, 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
Sunnybrook Research Institute ( Site 0108)
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Centre ( Site 0107)
Toronto Ontario, M5G 2, 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
CHU de Quebec-Universite 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
Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)
Santiago Region M. De Santiago, 84203, Chile
Centro de Investigaciones Clinicas Vina del Mar ( Site 1042)
Vina del Mar Valparaiso, 25404, Chile
Peking University First Hospital ( Site 1303)
Beijing Beijing, 10003, China
The Fifth Medical Center of PLA General Hospital ( Site 1307)
Beijing Beijing, 10007, China
Beijing Cancer Hospital ( Site 1305)
Beijing Beijing, 10014, China
The First Affiliated Hospital of Xiamen University ( Site 1319)
Xiamen Fujian, 36100, China
Sun Yat Sen Memorial Hospital ( Site 1323)
Guangzhou Guangdong, 51022, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 1330)
Guangzhou Guangdong, 51023, China
Harbin Medical University Cancer Hospital ( Site 1326)
Harbin Heilongjiang, 15008, China
Henan Cancer Hospital ( Site 1321)
Zhengzhou Henan, 45000, China
Hubei Cancer Hospital ( Site 1329)
Wuhan Hubei, 43007, China
Hunan Cancer Hospital ( Site 1320)
Changsha Hunan, 41001, China
Nanjing Drum Tower Hospital ( Site 1312)
Nanjing Jiangsu, 21000, China
Fudan University Shanghai Cancer Center ( Site 1300)
Shanghai Shanghai, 20003, China
Zhongshan Hospital Fudan University ( Site 1301)
Shanghai Shanghai, 20003, China
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309)
Hangzhou Zhejiang, 31000, China
Zhejiang Provincial People's Hospital ( Site 1310)
Hangzhou Zhejiang, 31001, China
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
Instituto Nacional de Cancerologia E.S.E ( Site 1061)
Bogota Distrito Capital De Bogota, 11032, Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)
Bogota Distrito Capital De Bogota, 11132, Colombia
Oncologos del Occidente S.A. ( Site 1072)
Pereira Risaralda, 66000, 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
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
Centre Leon Berard ( Site 0422)
Lyon Auvergne, 69373, France
Institut Paoli Calmettes. ( Site 0419)
Marseille Bouches-du-Rhone, 13009, France
CHU Jean Minjoz ( Site 0423)
Besancon Doubs, 25000, France
CHU de Brest -Site Hopital Morvan ( Site 0441)
Brest Finistere, 29200, 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, 92151, 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
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
Universitaetsklinikum in Mannheim ( Site 0314)
Mannheim Baden-Wurttemberg, 68167, 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 Wuerzburg ( Site 0302)
Wuerzburg Bayern, 97080, Germany
Universitaetsklinikum Goettingen ( Site 0345)
Goettingen Niedersachsen, 37075, Germany
Uniklinik RWTH Aachen ( Site 0308)
Aachen Nordrhein-Westfalen, 52074, Germany
Universitaetsklinikum des Saarlandes ( Site 0348)
Homburg Saarland, 66421, Germany
Universitaetsklinikum Jena ( Site 0305)
Jena Thuringen, 07747, Germany
Charite Universitaetsmedizin Berlin ( Site 0301)
Berlin , 10117, Germany
Cork University Hospital ( Site 0727)
Cork , T12 Y, Ireland
Tallaght University Hospital ( Site 0730)
Dublin , D24 N, Ireland
Mid Western Cancer Centre ( Site 0728)
Limerick , , Ireland
Soroka Medical Center ( Site 0548)
Beer Sheva , 84101, Israel
Assaf Harofeh MC ( Site 0547)
Beer Yaakov-Zerifin , 70300, Israel
Rambam Medical Center ( 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
Istituto Clinico Humanitas Research Hospital ( Site 0452)
Rozzano Milano, 20089, Italy
Azienda Ospedaliera Cannizzaro ( Site 0458)
Catania , 95126, Italy
A.O. Universitaria di Modena ( Site 0454)
Modena , 41100, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457)
Napoli , 80131, Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 0455)
Roma , 00152, Italy
Azienda Ospedaliera Santa Maria Terni ( Site 0456)
Terni , 05100, Italy
Presidio Ospedaliero Santa Chiara ( Site 0451)
Trento , 38122, 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
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
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, 1932, 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
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
Seoul National University Hospital ( Site 0171)
Seoul , 03080, Korea, Republic of
Asan Medical Center ( Site 0176)
Seoul , 05505, Korea, Republic of
Samsung Medical Center ( Site 0172)
Seoul , 06351, Korea, Republic of
Medisch Centrum Leeuwarden ( Site 0477)
Leeuwarden Fryslan, 8934 , Netherlands
Ziekenhuis Gelderse Vallei ( Site 0485)
Ede Gelderland, 6746 , Netherlands
Radboud University Medical Center ( Site 0470)
Nijmegen Gelderland, 6525 , Netherlands
VieCuri Medisch Centrum ( Site 0487)
Venlo Limburg, 5912 , Netherlands
Jeroen Bosch Ziekenhuis ( Site 1200)
Den Bosch Noord-Brabant, 5223 , Netherlands
Catharina Ziekenhuis ( Site 0472)
Eindhoven Noord-Brabant, 5623 , Netherlands
Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)
Amsterdam Noord-Holland, 1066 , Netherlands
Ziekenhuis Hilversum ( Site 0466)
Hilversum Noord-Holland, 1213 , Netherlands
Ziekenhuisgroep Twente ( Site 0469)
Hengelo Overijssel, 7555 , Netherlands
Reinier de Graaf Groep ( Site 0484)
Delft Zuid-Holland, 2625 , Netherlands
Hagaziekenhuis ( Site 1201)
Den Haag Zuid-Holland, 2545 , Netherlands
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
SBIH City clinical hospital named after D.D. Pletniov ( Site 0575)
Moscow Moskva, 10507, Russian Federation
Russian Scientific Center of Radiology ( Site 0559)
Moscow Moskva, 11748, Russian Federation
Central Clinical Hospital with Polyclinic ( Site 0562)
Moscow Moskva, 12135, Russian Federation
National Medical Research Radiological Center ( Site 0556)
Moscow Moskva, 12528, Russian Federation
Volga District Medical Center Federal Medical and Biological Agency ( Site 0572)
Nizhny Novgorod Nizhegorodskaya Oblast, 60307, 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
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
SPb SBHI City Clinical Oncological Dispensary ( Site 0571)
Saint Petersburg Sankt-Peterburg, 19825, Russian Federation
Leningrad Regional Oncology Center ( Site 0588)
Saint-Petersburg Sankt-Peterburg, 18866, Russian Federation
Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0579)
Tomsk Tomskaya Oblast, 63405, Russian Federation
Instituto Catalan de Oncologia - ICO ( Site 0330)
L Hospitalet De Llobregat Barcelona, 08908, Spain
Hospital Consorci Sanitari Parc Tauli ( Site 0335)
Sabadell Barcelona, 08208, Spain
Hospital Universitario Marques de Valdecilla ( Site 0336)
Santander Cantabria, 39008, Spain
Hospital Josep Trueta ( Site 0321)
Girona Gerona, 17007, Spain
Hospital del Mar ( Site 0333)
Barcelona , 08003, Spain
Hospital Clinic ( Site 0323)
Barcelona , 08036, Spain
Hospital Universitario Ramon y Cajal ( Site 0328)
Madrid , 28034, 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 , 40705, Taiwan
National Taiwan University Hospital ( Site 0131)
Taipei , 10048, Taiwan
Taipei Veterans General Hospital ( Site 0135)
Taipei , 11217, Taiwan
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
Weston Park Hospital ( Site 0539)
Sheffield England, S10 2, United Kingdom
Royal Marsden Hospital ( Site 0526)
Sutton England, SM2 5, United Kingdom
Mount Vernon Cancer Centre ( Site 0536)
Northwood Hertfordshire, HA6 2, United Kingdom
Barts Cancer Institute ( Site 0483)
London London, City Of, EC1A , United Kingdom
University of North Midlands NHS Foundation Trust ( Site 0527)
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1090

Study ID:

NCT03834506

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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