Clinical trial NCT01212991: A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
Official title: PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Progressive Metastatic Prostate Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
name: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
First posted: 2010-10-01
Enrollment: 1717
Sex: MALE
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 determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.


Eligibility criteria: Randomized, Double Blind Treatment Period:

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
* Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
* Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
* No prior treatment with cytotoxic chemotherapy
* Asymptomatic or mildly symptomatic from prostate cancer

Exclusion Criteria:

* Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
* Known or suspected brain metastasis or active leptomeningeal disease
* History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer

Open-Label Treatment Period:

The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment.

Eligible patients must meet all inclusion criteria.

* Received randomized double-blind treatment in PREVAIL;
* Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;
* Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy;

The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. Each patient must not meet any of the following criteria:

* Has taken commercially available enzalutamide (Xtandi);
* Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
* Known or suspected brain metastasis or active leptomeningeal disease

Primary outcomes:
measure: Overall Survival
timeFrame: During study period (up to 3 years)
measure: Radiographic Progression-free Survival (rPFS)
timeFrame: During study period (up to 20 months)
Secondary outcomes:
measure: Time to First Skeletal-related Event
timeFrame: During study period (up to 3 years)
measure: Time to Initiation of Cytotoxic Chemotherapy
timeFrame: During study period (up to 3 years)
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: During study period (up to 3 years)
measure: Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%
timeFrame: During study period (up to 3 years)
measure: Best Overall Soft Tissue Response
timeFrame: During study period (up to 3 years)
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria for AEs (CTCAE), Version 4.0
timeFrame: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
measure: Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: The University of Arizona Cancer Center-North Campus
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Cancer Certer-North Campus
state: Arizona
city: La Mesa
country: United States
facility: Cancer Center Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: LAC&USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services
state: California
city: Los Angeles
country: United States
facility: UCLA Clark Urology Clinic
state: California
city: Oceanside
country: United States
facility: North County Oncology Medical Clinic, Inc
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: Medical Oncology Associates-SD
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital Investigational Pharmacy
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Center Pavilion Pharmacy
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital, Anschutz Cancer Pavilion
state: Colorado
city: Boca Raton
country: United States
facility: Lynn Cancer Institute Center for Hematology Oncology
state: Florida
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Louisville
country: United States
facility: Jewish Hospital & St. Mary's Healthcare, Inc.
state: Kentucky
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaoness Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Creve Coeur
country: United States
facility: Barnes-Jewish West County Hospital
state: Missouri
city: Saint Louis
country: United States
facility: BJH Pharmacy
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Peters
country: United States
facility: Barnes-Jewish St. Peters Hospital
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Cary
country: United States
facility: Cancer Centers of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute - Main
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute - Southpark
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute - University
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute - Ballantyne
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Durham
country: United States
facility: Investigational Chemotherapy Services
state: North Carolina
city: Raleigh
country: United States
facility: Cancer Centers of North Carolina
state: North Carolina
city: Portland
country: United States
facility: Portland VA Medical Center Laboratory
state: Oregon
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Hematology / Oncology MUSC Hollings Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina - Urology Services
state: South Carolina
city: Charleston
country: United States
facility: MUSC Department of Radiology
state: South Carolina
city: Charleston
country: United States
facility: MUSC Urology Ambulatory Care
state: South Carolina
city: Mount Pleasant
country: United States
facility: MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor
state: South Carolina
city: Mount Pleasant
country: United States
facility: MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Hampton
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St George Private Hospital
state: New South Wales
city: Lismore
country: Australia
facility: Lismore Base Hospital, Lismore Cancer Care and Haematology Unit
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Port Macquarie
country: Australia
facility: North Coast Cancer Institute
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital, Department of Medical Oncology
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Wahroonga
country: Australia
facility: Australian Clinical Trials Pty Ltd
state: New South Wales
city: Wahroonga
country: Australia
facility: SAN Pathology
state: New South Wales
city: Wahroonga
country: Australia
facility: SAN Radiology
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Heart Care Partners
state: Queensland
city: Auchenflower
country: Australia
facility: Icon Cancer Care Wesley
state: Queensland
city: Auchenflower
country: Australia
facility: River City Pharmacy
state: Queensland
city: Chermside
country: Australia
facility: Icon Cancer Care Chermside
state: Queensland
city: Herston
country: Australia
facility: University of Queensland Centre for Clinical Research (UQCCR)
state: Queensland
city: Herston
country: Australia
facility: Nuclear Medicine and Imaging Department
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care South Brisbane
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Foundation
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Private Cardiology
state: Queensland
city: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre
state: South Australia
city: Kurralta Park
country: Australia
facility: APHS Pharmacy
state: South Australia
city: Kurralta park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Kurralta Park
country: Australia
facility: Cancer Care SA Pty Ltd
state: South Australia
city: Bendigo
country: Australia
facility: Bendigo Health, Bendigo Hospital
state: Victoria
city: Bendigo
country: Australia
facility: Bendigo Health Medical Imaging
state: Victoria
city: Box Hill
country: Australia
facility: Eastern Health
state: Victoria
city: Box Hill
country: Australia
facility: MIA Box Hill Radiology
state: Victoria
city: Box Hill
country: Australia
facility: Oncology Eastern Clinical Research Unit (ECRU)
state: Victoria
city: Box Hill
country: Australia
facility: Pharmacy Department
state: Victoria
city: Brighton
country: Australia
facility: Cabrini Hospital Brighton
state: Victoria
city: Clayton
country: Australia
facility: Monash Health Translation Precinct
state: Victoria
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health, Geelong Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Malvern,
country: Australia
facility: Cabrini Hospital Malvern
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Radiology
state: Victoria
city: Malvern
country: Australia
facility: MDI Chemer
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz
city: Salzburg
country: Austria
facility: Ordination Dr. Fink
city: Salzburg
country: Austria
facility: Salzburger Universitatsklinikum
city: Wien
country: Austria
facility: Medizinische Universitaet Wien
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Ghent
country: Belgium
facility: AZ Sint-Lucas
city: Hasselt
country: Belgium
facility: Jessaziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge, Campus KL
city: Leuven
country: Belgium
facility: UZ Leuven - University Hospital Gasthuisberg
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege-Urologie
city: Calgary
country: Canada
facility: Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
state: Alberta
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre - Holy Cross Site
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency, Sindi Ahluwalia Hawkins, Centre for the Southern Interior
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre
state: British Columbia
city: Victoria
country: Canada
facility: Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging
state: British Columbia
city: Victoria
country: Canada
facility: British Columbia Cancer Agency - Vancouver Island Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Prostate Centre
state: Manitoba
city: Halifax
country: Canada
facility: QEII Health Sciences Centre, Nova Scotia Cancer Centre.
state: Nova Scotia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre at Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London RegCancer Program, London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre, General Campus
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - L'Hotel-Dieu de Quebec
city: Quebec
country: Canada
facility: Centre de recherche clinique el evaluative en oncologie (CRCEO)
city: Aalborg
country: Denmark
facility: Aalborg Hospital Nord
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Roskilde
country: Denmark
facility: Roskilde Sygehus
city: Helsinki
country: Finland
facility: Docrates Clinic
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Strasbourg
country: France
facility: Hopital Civil
state: Alsace
city: Rennes cedex
country: France
facility: Centre Eugene Marquis-Service d'Oncologie Medicale
state: Bretagne
city: Bordeaux
country: France
facility: Institut Bergonie
state: Nouvelle Aquitaine
city: Angers
country: France
facility: ICO Paul Papin
city: Avignon
country: France
facility: Clinique Rhone Durance
city: Bordeaux
country: France
facility: Institut Bergonie
city: La Roche sur Yon Cedex
country: France
facility: CHD Vendee
city: Le Mans
country: France
facility: Centre Jean Bernard - Clinique Victor Hugo
city: Lyon
country: France
facility: Centre Leon Berard
city: Paris Cedex 15
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Groupe Hospitalier La Pitie Salpetriere
city: Saint Herblain Cedex
country: France
facility: Centre de Recherche Clinique
city: Saint-Mande
country: France
facility: HIA Begin, Service de Medecine Interne et Oncologie
city: Saint-Priest en Jarez
country: France
facility: Institut de Cancerologie Lucien Neuwirth
city: Toulouse
country: France
facility: Clinique Pasteur
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
city: Braunschweig
country: Germany
facility: Staedtisches Klinikum Braunschweig gGmbH
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden an der
city: Hamburg
country: Germany
facility: Martini-Klinik am UKE Gmbh
city: Hamburg
country: Germany
facility: Urologikum Hamburg
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg, Klinik Fuer Urologie
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim, Klinik fuer Urologie
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Weiden In Der Oberpfalz
country: Germany
facility: Kliniken Nordoberpfalz AG, Klinikum Weiden
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Beer Yaakov
country: Israel
facility: Assaf Harofe Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Cremona
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Cremona
state: CR
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
state: FC
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga
state: TO
city: Arezzo
country: Italy
facility: Azienda USL8-Presidio Ospedaliero S.Donato
city: Forli
country: Italy
facility: Ospedale G.B. Morgagni
city: Rome
country: Italy
facility: Azienda Ospedaliera San. Camillo Forlanini
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa-ken
city: Sendai-Shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Osaka-sayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Tokushima-shi
country: Japan
facility: Tokushima University Hospital
state: Tokushima
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Koutou-ku
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Tokyo
country: Japan
facility: Jikei University Hospital
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Hwasun-eup, Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonnam
city: Gangnam-gu
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Vilnius
country: Lithuania
facility: Division of Oncourology, National Cancer Institute
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medical Center, Department of Medical Oncology
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Groningen
country: Netherlands
facility: University Medical Center Groningen, Department of Urology
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A.
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Tramatologii im. M.Kopernika w Lodzi
state: Lodzkie
city: Gdansk
country: Poland
facility: Apteka Szpitalna
state: Pomorskie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Myslowice
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej
state: Slaskie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii
state: Wielkopolskie
city: Moscow
country: Russian Federation
facility: Russian Academy of Medical Sciences Institution
city: St-Petersburg
country: Russian Federation
facility: State Educational Institution of Higher Professional Education
city: St-Petersburg
country: Russian Federation
facility: State healthcare institute
city: St.-Petersburg
country: Russian Federation
facility: North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare
city: Singapore
country: Singapore
facility: Department of Urology, National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica
city: Bratislava
country: Slovakia
facility: CUIMED s.r.o.
city: Martin
country: Slovakia
facility: Univerzitna Nemocnica Martin
city: Nitra
country: Slovakia
facility: UROEXAM, spol. s r.o. urologicka ambulancia
city: Presov
country: Slovakia
facility: Poliklinika Sekcov, wesper, s.r.o.
city: Presov
country: Slovakia
facility: UROCENTRUM MILAB s.r.o.
city: Badalona
country: Spain
facility: Hospital Universitario German Trias i Pujol
state: Barcelona
city: Manresa
country: Spain
facility: Althaia Xarxa Asistencial Manresa
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Islas Baleares
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Madrid Norte Sanchinarro
city: Sabadell(Barcelona)
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Malmo
country: Sweden
facility: Skane University Hospital
city: Orebro
country: Sweden
facility: Orebro University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Umea
country: Sweden
facility: Umea University Hospital
city: Northwood
country: United Kingdom
facility: Bishops Wood Hospital
state: Middlesex
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
state: Middlesex
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
state: Oxfordshire
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care
state: Tyne and Wear
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
state: Wales
city: Bebington
country: United Kingdom
facility: Clatterbridge Cancer Centre NHS Foundation Trust
state: Wirral, Merseyside
city: Brighton, East Sussex
country: United Kingdom
facility: Clinical Investigations and Research Unit, Royal Sussex County Hospital
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre
city: London
country: United Kingdom
facility: University College London Hospital NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
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