Clinical trial NCT06136650: 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)
Official title: MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)
Prostatic Neoplasms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2023-11-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are 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) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.


Eligibility criteria: 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 current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography scan (CT)/magnetic resonance imaging (MRI)
* Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
* 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 six cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
* Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization
* Has ongoing androgen deprivation therapy (ADT) with serum testosterone \<50 ng/dL (\<1.7 nM)
* Has had prior treatment with Poly polymerase inhibitors (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
* Has adequate organ function
* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening
* Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria:

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

* Has presence of gastrointestinal condition
* Is unable to swallow capsules/tablets
* Has history of pituitary dysfunction
* Has poorly controlled diabetes mellitus
* Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
* 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
* History or family history of long QTc syndrome
* Has a history of seizure(s) within 6 months prior to signing the 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

Primary outcomes:
measure: Radiographic Progression-free Survival (rPFS)
timeFrame: Up to approximately 82 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 82 months
Secondary outcomes:
measure: Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
timeFrame: Up to approximately 82 months
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 82 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 82 months
measure: Time to Pain Progression (TTPP)
timeFrame: Up to approximately 82 months
measure: Prostrate-specific Antigen (PSA) Response Rate
timeFrame: Up to approximately 82 months
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: Up to approximately 82 months
measure: Time to first symptomatic skeletal-related event (TSSRE)
timeFrame: Up to approximately 82 months
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 82 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 82 months
measure: Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score
timeFrame: Baseline, and up to approximately 82 months
measure: Time to Deterioration (TTD) in FACT-G Total Score
timeFrame: Up to approximately 82 months
measure: Overall Improvement in FACT-G Total Score
timeFrame: Up to approximately 82 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center - North Campus ( Site 0073)
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica ( Site 0044)
state: California
city: Orange
country: United States
facility: University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Center ( Site 0036)
state: California
city: Redlands
country: United States
facility: Emad Ibrahim,MD,INC. ( Site 0012)
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center ( Site 0099)
state: California
city: Sacramento
country: United States
facility: University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114)
state: California
city: San Francisco
country: United States
facility: San Francisco VA Health Care System ( Site 0093)
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus ( Site 0046)
state: Colorado
city: Highlands Ranch
country: United States
facility: UCHealth Highlands Ranch Hospital ( Site 0111)
state: Colorado
city: Lakewood
country: United States
facility: Colorado Clinical Research ( Site 0067)
state: Colorado
city: Lone Tree
country: United States
facility: University of Colorado Health - Lone Tree Medical Center ( Site 0112)
state: Colorado
city: New Haven
country: United States
facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center ( Site 0103)
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South ( Site 7003)
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Cancer Center ( Site 0107)
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital-Northside Hospital Oncology Network ( Site 0100)
state: Georgia
city: Elmhurst
country: United States
facility: Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074)
state: Illinois
city: Naperville
country: United States
facility: Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075)
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care ( Site 0104)
state: Illinois
city: Carmel
country: United States
facility: Urology of Indiana - Carmel ( Site 0055)
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center ( Site 0048)
state: Kentucky
city: Baltimore
country: United States
facility: Baltimore Veterans Affairs Medical Center ( Site 0069)
state: Maryland
city: Baltimore
country: United States
facility: Greenebaum Comprehensive Cancer Center ( Site 0049)
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology ( Site 0009)
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital ( Site 0015)
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan ( Site 0005)
state: Michigan
city: Saint Louis Park
country: United States
facility: HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072)
state: Minnesota
city: Saint Paul
country: United States
facility: HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092)
state: Minnesota
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center-Research ( Site 0037)
state: Montana
city: Omaha
country: United States
facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
state: Nebraska
city: Las Vegas
country: United States
facility: OptumCare Cancer Care-Research Department ( Site 0078)
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada ( Site 0010)
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 0033)
state: New Jersey
city: Syracuse
country: United States
facility: Associated Medical Professionals - Urology ( Site 0081)
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 0043)
state: Ohio
city: Gahanna
country: United States
facility: Central Ohio Urology Group - Gahanna ( Site 0098)
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare System ( Site 0102)
state: Ohio
city: Bala-Cynwyd
country: United States
facility: MidLantic urology ( Site 0022)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center ( Site 0076)
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)
state: South Carolina
city: Pierre
country: United States
facility: Avera Cancer Institute - Pierre ( Site 0118)
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute- Research ( Site 0094)
state: South Dakota
city: Yankton
country: United States
facility: Avera Cancer Institute - Yankton ( Site 0117)
state: South Dakota
city: Germantown
country: United States
facility: The West Clinic, PLLC dba West Cancer Center ( Site 0063)
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Central/South Texas ( Site 8003)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - DFW ( Site 8001)
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas, PLLC ( Site 0077)
state: Texas
city: Houston
country: United States
facility: Texas Oncology - Gulf Coast ( Site 8002)
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System ( Site 0054)
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0017)
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists (VCS) ( Site 8004)
state: Virginia
city: Richmond
country: United States
facility: VCU Health Adult Outpatient Pavillion ( Site 0061)
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care ( Site 0004)
state: Virginia
city: Spokane
country: United States
facility: Spokane Urology ( Site 0035)
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists (Compass Oncology) ( Site 8008)
state: Washington
city: Milwaukee
country: United States
facility: MEDICAL COLLEGE OF WISCONSIN ( Site 0020)
state: Wisconsin
city: Macquarie University
country: Australia
facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 0214)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 0212)
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0211)
state: Queensland
city: Clayton
country: Australia
facility: Monash Health ( Site 0219)
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210)
state: Victoria
city: Salvador
country: Brazil
facility: Obras Sociais Irma Dulce ( Site 0255)
state: Bahia
city: Fortaleza
country: Brazil
facility: CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0256)
state: Ceara
city: Vitória
country: Brazil
facility: Hospital Santa Rita de Cassia ( Site 0271)
state: Espirito Santo
city: Sao Luis
country: Brazil
facility: Hospital São Domingos ( Site 0258)
state: Maranhao
city: Belo Horizonte
country: Brazil
facility: Hospital Mario Penna ( Site 0264)
state: Minas Gerais
city: Uberaba
country: Brazil
facility: Universidade Federal do Triangulo Mineiro - Hospital de Clinicas ( Site 0262)
state: Minas Gerais
city: Curitiba
country: Brazil
facility: ICTRIALS Pesquisa e Desenvolvimento ( Site 0274)
state: Parana
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS ( Site 0270)
state: Rio Grande Do Sul
city: Bragança Paulista
country: Brazil
facility: Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0251)
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base de São José do Rio Preto ( Site 0275)
state: Sao Paulo
city: Taubaté
country: Brazil
facility: Instituto do Câncer Brasil - Unidade Taubaté ( Site 0263)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano ( Site 0259)
city: Quebec City
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0277)
state: Quebec
city: Temuco
country: Chile
facility: CIDO SpA-Oncology ( Site 0302)
state: Araucania
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule-Oncology ( Site 0306)
state: Maule
city: Santiago
country: Chile
facility: FALP ( Site 0303)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0304)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0301)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS-ACEREY ( Site 0305)
state: Valparaiso
city: Hefei
country: China
facility: The Second Hospital Of Anhui Medical University ( Site 1633)
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital-Urology ( Site 1602)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital-Urinary Surgery ( Site 1620)
state: Beijing
city: Beijing
country: China
facility: First Medical Center of Chinese PLA General Hospital ( Site 1601)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 1623)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital ( Site 1603)
state: Chongqing
city: Chongqing
country: China
facility: Southwest Hospital of Third Military Medical University ( Site 1645)
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 1639)
state: Fujian
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou medical university ( Site 1637)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center-Urology Surgery ( Site 1638)
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 1632)
state: Hubei
city: Wuhan
country: China
facility: The Central Hospital of Wuhan ( Site 1635)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital-Urinary surgery ( Site 1631)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 1630)
state: Hunan
city: NanJing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1615)
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital-Urology ( Site 1609)
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital ( Site 1612)
state: Jiangsu
city: XI An
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University-Oncology department ( Site 1618)
state: Shaanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University-Oncology Department ( Site 1619)
state: Shaanxi
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital ( Site 1622)
state: Shandong
city: Shanghai
country: China
facility: Renji Hosp Shanghai Jiaotong U School of Med ( Site 1624)
state: Shanghai
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University-Urology ( Site 1613)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University-Urology Surgery ( Site 1642)
state: Sichuan
city: Nanchong
country: China
facility: Nanchong Central Hospital-urology ( Site 1647)
state: Sichuan
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University ( Site 1616)
state: Tianjin
city: Urumqi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 1644)
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital ( Site 1643)
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital-Urology ( Site 1641)
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing-urology ( Site 1605)
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital-Urology ( Site 1608)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 1604)
state: Zhejiang
city: Valledupar
country: Colombia
facility: Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0327)
state: Cesar
city: Monteria
country: Colombia
facility: IMAT S.A.S ( Site 0329)
state: Cordoba
city: Bogota
country: Colombia
facility: Los Cobos Medical Center ( Site 0336)
state: Distrito Capital De Bogota
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0326)
state: Distrito Capital De Bogota
city: Piedecuesta
country: Colombia
facility: Fundación Cardiovascular de Colombia ( Site 0328)
state: Santander
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0330)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Clínica Imbanaco S.A.S ( Site 0334)
state: Valle Del Cauca
city: San José
country: Costa Rica
facility: CIMCA-Hemato-Oncology ( Site 0380)
state: San Jose
city: Santa Ana
country: Costa Rica
facility: Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0379)
state: San Jose
city: San Jose
country: Costa Rica
facility: Onco Tech, S.A. ( Site 0376)
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0403)
state: Brno-mesto
city: Brno
country: Czechia
facility: Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0404)
state: Jihomoravsky Kraj
city: Liberec
country: Czechia
facility: Krajská nemocnice Liberec-Department of Urology ( Site 0407)
state: Liberecky Kraj
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0401)
state: Praha 5
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0405)
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze ( Site 0406)
city: Tallinn
country: Estonia
facility: East-Tallinn Central Hospital ( Site 1528)
state: Harjumaa
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation ( Site 1526)
state: Harjumaa
city: Tartu
country: Estonia
facility: Tartu University Hospital-Radiotherapy and oncology ( Site 1527)
state: Tartumaa
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0451)
state: Alsace
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0461)
state: Aquitaine
city: Brest
country: France
facility: CHU-BREST Cavale Blanche ( Site 0456)
state: Finistere
city: Quint-Fonsegrives
country: France
facility: Ramsay Santé - Clinical La Croix Du Sud ( Site 0460)
state: Haute-Garonne
city: Suresnes
country: France
facility: Hôpital Foch ( Site 0455)
state: Hauts-de-Seine
city: Lille
country: France
facility: Centre Bourgogne ( Site 0464)
state: Nord-Pas-de-Calais
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0454)
state: Puy-de-Dome
city: Lyon Cedex08
country: France
facility: CENTRE LEON BERARD ( Site 0459)
state: Rhone-Alpes
city: Villejuif
country: France
facility: Gustave Roussy ( Site 0452)
state: Val-de-Marne
city: Avignon
country: France
facility: Sainte Catherine Institut du Cancer Avignon Provence ( Site 0458)
state: Vaucluse
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph ( Site 0465)
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg-Klinik für Urologie ( Site 0506)
state: Baden-Wurttemberg
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg ( Site 0531)
state: Baden-Wurttemberg
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie ( Site 0529)
state: Baden-Wurttemberg
city: Munich
country: Germany
facility: klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0521)
state: Bayern
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0523)
state: Bayern
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 0510)
state: Hessen
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Urologie ( Site 0527)
state: Niedersachsen
city: Bergisch Gladbach
country: Germany
facility: Marien-Krankenhaus ( Site 0515)
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln ( Site 0518)
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0528)
state: Sachsen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban ( Site 0512)
city: Patras
country: Greece
facility: UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0553)
state: Achaia
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0551)
state: Attiki
city: Chaidari
country: Greece
facility: ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Site 0552)
state: Attiki
city: Ciudad de Guatemala
country: Guatemala
facility: Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0577)
city: Guatemala
country: Guatemala
facility: MEDI-K ( Site 0576)
city: Guatemala
country: Guatemala
facility: CELAN,S.A ( Site 0579)
city: Guatemala
country: Guatemala
facility: INTEGRA Cancer Institute-Oncology ( Site 0578)
city: Guatemala
country: Guatemala
facility: Sanatorio Nuestra Senora del Pilar ( Site 0580)
city: Central
country: Hong Kong
facility: Hong Kong Integrated Oncology Centre ( Site 0603)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 0602)
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C ( Site 0630)
state: Borsod-Abauj-Zemplen
city: Salgótarján
country: Hungary
facility: Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0636)
state: Nograd
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0631)
state: Pest
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0632)
city: Dublin 04
country: Ireland
facility: St. Vincent's University Hospital ( Site 0652)
state: Dublin
city: Dublin
country: Ireland
facility: Tallaght University Hospital ( Site 0651)
city: Afula
country: Israel
facility: Emek Medical Center ( Site 0680)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 0676)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 0679)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 0683)
city: Kfar Saba
country: Israel
facility: Meir Medical Center. ( Site 0682)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0678)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0677)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0681)
city: Meldola
country: Italy
facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1454)
state: Emilia-Romagna
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1452)
state: Lombardia
city: Catania
country: Italy
facility: Ospedale Cannizzaro ( Site 1455)
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 1456)
city: Milano
country: Italy
facility: Ospedale San Raffaele-Oncologia Medica ( Site 1451)
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni ( Site 1458)
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center ( Site 0730)
state: Chiba
city: Eiheiji-cho,Yoshida-gun
country: Japan
facility: University of Fukui Hospital ( Site 0735)
state: Fukui
city: Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan ( Site 0746)
state: Fukuoka
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital ( Site 0726)
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 0756)
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University Hospital ( Site 0741)
state: Hyogo
city: Uchinada
country: Japan
facility: Kanazawa Medical University Hospital ( Site 0734)
state: Ishikawa
city: Kita
country: Japan
facility: Kagawa University Hospital ( Site 0744)
state: Kagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center ( Site 0733)
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Hospital ( Site 0737)
state: Mie
city: Ōmura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center ( Site 0748)
state: Nagasaki
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 0742)
state: Nara
city: Shimajiri
country: Japan
facility: Nanbu Tokushukai Hospital ( Site 0755)
state: Okinawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 0739)
state: Osaka
city: Sakai
country: Japan
facility: Bell Land General Hospital ( Site 0740)
state: Osaka
city: Suita
country: Japan
facility: The University of Osaka Hospital ( Site 0738)
state: Osaka
city: Saga-shi
country: Japan
facility: Saga-Ken Medical Centre Koseikan ( Site 0747)
state: Saga
city: Itabashiku
country: Japan
facility: Nihon University Itabashi Hospital ( Site 0732)
state: Tokyo
city: Minato
country: Japan
facility: The Jikei University Hospital ( Site 0731)
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital ( Site 0728)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0745)
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital ( Site 0758)
city: Gifu
country: Japan
facility: Gifu University Hospital ( Site 0736)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 0743)
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital ( Site 0754)
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center ( Site 0749)
city: Miyazaki
country: Japan
facility: Miyazaki Prefectural Miyazaki Hospital ( Site 0752)
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital ( Site 0751)
city: Nagano
country: Japan
facility: Nagano Municipal Hospital ( Site 0757)
city: Oita
country: Japan
facility: National Hospital Organization Oita Medical Center ( Site 0750)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center-Center for Urologic Cancer ( Site 1254)
state: Kyonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital-Urology ( Site 1253)
state: Kyonggi-do
city: Buk-gu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital-Urology ( Site 1252)
state: Kyongsangbuk-do
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital ( Site 1256)
state: Kyongsangnam-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital-Urology ( Site 1251)
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1255)
city: Liepaja
country: Latvia
facility: Liepaja Regional Hospital ( Site 1553)
city: Riga
country: Latvia
facility: Pauls Stradins Clinical Univeristy Hospital-Urological department ( Site 1551)
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 1576)
state: Kauno Apskritis
city: Vilnius
country: Lithuania
facility: National Cancer Institute ( Site 1577)
state: Vilniaus Miestas
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail ( Site 0905)
state: Johor
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre ( Site 0902)
state: Kuala Lumpur
city: Kuching
country: Malaysia
facility: Sarawak General Hospital-Radiotherapy Unit ( Site 0901)
state: Sarawak
city: Putrajaya
country: Malaysia
facility: National Cancer Institute ( Site 0904)
state: Wilayah Persekutuan Putrajaya
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 0903)
city: Ciudad de México
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V: ( Site 0929)
state: Distrito Federal
city: Ciudad de México
country: Mexico
facility: Higiea Oncologia ( Site 0938)
state: Distrito Federal
city: Tlalpan
country: Mexico
facility: Quemex Medical and Research ( Site 0937)
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Filios Alta Medicina ( Site 0931)
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0932)
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Eukarya Pharmasite S.C. ( Site 0939)
state: Nuevo Leon
city: Oaxaca de Juarez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 0934)
state: Oaxaca
city: Dunedin
country: New Zealand
facility: Dunedin Hospital ( Site 1032)
state: Otago
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 1033)
city: Lima
country: Peru
facility: Aliada-Oncologìa ( Site 1055)
city: Lima
country: Peru
facility: IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1052)
city: Lima
country: Peru
facility: Oncosalud-Clinical Research ( Site 1057)
city: Lima
country: Peru
facility: INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1054)
city: Alcabideche
country: Portugal
facility: Hospital de Cascais Doutor José de Almeida ( Site 1158)
state: Lisboa
city: Vila Nova de Gaia
country: Portugal
facility: Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1156)
state: Porto
city: Braga
country: Portugal
facility: Unidade Local de Saude de Braga - Hospital de Braga ( Site 1151)
city: Lisboa
country: Portugal
facility: Hospital CUF - Tejo ( Site 1157)
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1153)
city: Porto
country: Portugal
facility: Unidade Local de Saude de Santo António - Hospital Santo António ( Site 1152)
city: Ponce
country: Puerto Rico
facility: Advance Urology and Laparoscopic Center ( Site 1178)
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research-Research ( Site 1177)
city: San Juan
country: Puerto Rico
facility: Pan American Center for Oncology Trials - Ciudadela ( Site 1176)
city: București
country: Romania
facility: Spitalul Universitar de Urgență Elias ( Site 1504)
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca ( Site 1503)
state: Cluj
city: Florești
country: Romania
facility: SC Radiotherapy Center Cluj SRL ( Site 1502)
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie "Sfântul Nectarie" ( Site 1501)
state: Dolj
city: Singapore
country: Singapore
facility: National University Hospital ( Site 1201)
state: Central Singapore
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore ( Site 1202)
state: Central Singapore
city: Singapore
country: Singapore
facility: Singapore General Hospital ( Site 1204)
state: Central Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital-Medical Oncology ( Site 1203)
state: Central Singapore
city: Nitra
country: Slovakia
facility: UROEXAM ( Site 1479)
state: Nitriansky Kraj
city: Trencin
country: Slovakia
facility: Privatna Urologicka Ambulancia ( Site 1478)
state: Trenciansky Kraj
city: Port Elizabeth
country: South Africa
facility: CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1230)
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Wits Clinical Research ( Site 1234)
state: Gauteng
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre ( Site 1232)
state: Gauteng
city: Pretoria
country: South Africa
facility: Curo Oncology. ( Site 1237)
state: Gauteng
city: Pretoria
country: South Africa
facility: LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1236)
state: Gauteng
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials ( Site 1233)
state: Western Cape
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli-oncologia ( Site 1282)
state: Barcelona
city: Barcelona
country: Spain
facility: HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1284)
state: Cataluna
city: Girona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Girona ( Site 1285)
state: Gerona
city: A Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruna ( Site 1288)
state: La Coruna
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria-Oncology ( Site 1280)
state: Las Palmas
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1283)
state: Madrid
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos-Oncología ( Site 1281)
city: Malaga
country: Spain
facility: Hospital Quirón Málaga ( Site 1286)
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 1302)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1301)
state: Uppsala Lan
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center ( Site 1336)
state: Tainan
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital ( Site 1337)
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1331)
city: Taichung
country: Taiwan
facility: China Medical University Hospital-Department of Urology ( Site 1335)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1332)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1334)
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 1353)
state: Chiang Mai
city: Muang
country: Thailand
facility: Faculty of Medicine - Khon Kaen University ( Site 1351)
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 1355)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 1356)
state: Krung Thep Maha Nakhon
city: Hatyai
country: Thailand
facility: Songklanagarind hospital ( Site 1352)
state: Songkhla
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1379)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 1376)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1377)
city: Istanbul
country: Turkey
facility: Koc Universitesi Hastanesi ( Site 1384)
city: Istanbul
country: Turkey
facility: T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1381)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1383)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1378)
city: Izmir
country: Turkey
facility: Ege Universitesi Hastanesi-Medical Oncology ( Site 1380)
city: Samsun
country: Turkey
facility: Samsun Medical Park Hastanesi-medical oncology ( Site 1382)
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital ( Site 1426)
state: Cambridgeshire
city: Derby
country: United Kingdom
facility: Royal Derby Hospital ( Site 1431)
state: Derbyshire
city: Torquay
country: United Kingdom
facility: Torbay Hospital ( Site 1429)
state: Devon
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 1440)
state: England
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital ( Site 1430)
state: England
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre ( Site 1428)
state: Glasgow City
city: London
country: United Kingdom
facility: Charing Cross Hospital-Oncology Research ( Site 1434)
state: Hammersmith And Fulham
city: London
country: United Kingdom
facility: University College London Hospital ( Site 1437)
state: London, City Of
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435)
state: London, City Of
city: London
country: United Kingdom
facility: St. George's Hospital-Oncology ( Site 1441)
state: London, City Of
city: Oxford
country: United Kingdom
facility: GenesisCare - Oxford ( Site 1442)
state: Oxfordshire
city: Windsor
country: United Kingdom
facility: GenesisCare - Windsor ( Site 1443)
state: Windsor And Maidenhead
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 1436)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: