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A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer (PREVAIL)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01212991
First Posted: October 1, 2010
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Drug: Enzalutamide Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: During study period (up to 3 years) ]
    Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.

  • Radiographic Progression-free Survival [ Time Frame: During study period (up to 20 months) ]
    Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.


Secondary Outcome Measures:
  • Time to First Skeletal-related Event [ Time Frame: During study period (up to 3 years) ]
    Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.

  • Time to Initiation of Cytotoxic Chemotherapy [ Time Frame: During study period (up to 3 years) ]
    The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was censored on the date of randomization.

  • Time to Prostate-specific Antigen (PSA) Progression [ Time Frame: During study period (up to 3 years) ]
    Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.

  • Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50% [ Time Frame: During study period (up to 3 years) ]
    PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.

  • Best Overall Soft Tissue Response [ Time Frame: During study period (up to 3 years) ]
    The best overall soft tissue objective response is defined as partial response [PR] or complete response [CR] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.


Enrollment: 1735
Actual Study Start Date: June 22, 2010
Estimated Study Completion Date: September 28, 2018
Primary Completion Date: September 30, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide Drug: Enzalutamide
Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.
Placebo Comparator: Placebo Drug: Placebo
Participants received placebo, administered as four capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212991


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
The University of Arizona Cancer Certer-North Campus
Tucson, Arizona, United States, 85719
United States, California
USC Westside Prostate Cancer Center
Beverly Hills, California, United States, 90211
Cancer Center Oncology Medical Group
La Mesa, California, United States, 91942
Keck Hospital of USC
Los Angeles, California, United States, 90033
LAC&USC Medical Center
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services
Los Angeles, California, United States, 90095
UCLA Clark Urology Clinic
Los Angeles, California, United States, 90095
North County Oncology Medical Clinic, Inc
Oceanside, California, United States, 92056
UC Davis Cancer Center
Sacramento, California, United States, 95817
UC Davis Medical Center
Sacramento, California, United States, 95817
Medical Oncology Associates-SD
San Diego, California, United States, 92123
Sharp Memorial Hospital Investigational Pharmacy
San Diego, California, United States, 92123
Sharp Rees-Stealy
San Diego, California, United States, 92123
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
Anschutz Cancer Center Pavilion Pharmacy
Aurora, Colorado, United States, 80045
University of Colorado Hospital, Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Florida
Lynn Cancer Institute Center for Hematology Oncology
Boca Raton, Florida, United States, 33486
United States, Illinois
Northwestern Memorial Faculty Foundation
Chicago, Illinois, United States, 60611
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Kentucky
Jewish Hospital & St. Mary's Healthcare, Inc.
Louisville, Kentucky, United States, 40245
United States, Massachusetts
Beth Israel Deaoness Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Karmanos Cancer Institute at Farmington Hills
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Barnes-Jewish West County Hospital
Creve Coeur, Missouri, United States, 63141
BJH Pharmacy
Saint Louis, Missouri, United States, 63108
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Barnes-Jewish St. Peters Hospital
Saint Peters, Missouri, United States, 63376
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, New York
The Mount Sinai Medical Center
New York, New York, United States, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Cancer Centers of North Carolina
Cary, North Carolina, United States, 27518
Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Levine Cancer Institute - Main
Charlotte, North Carolina, United States, 28204
Levine Cancer Institute - Southpark
Charlotte, North Carolina, United States, 28211
Levine Cancer Institute - University
Charlotte, North Carolina, United States, 28262
Levine Cancer Institute - Ballantyne
Charlotte, North Carolina, United States, 28277
Duke University Medical Center
Durham, North Carolina, United States, 27710
Investigational Chemotherapy Services
Durham, North Carolina, United States, 27710
Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
United States, Oregon
Portland VA Medical Center Laboratory
Portland, Oregon, United States, 97239
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
UPCI - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Hematology / Oncology MUSC Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Medical University of South Carolina - Urology Services
Charleston, South Carolina, United States, 29425
MUSC Department of Radiology
Charleston, South Carolina, United States, 29425
MUSC Urology Ambulatory Care
Charleston, South Carolina, United States, 29425
MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor
Mount Pleasant, South Carolina, United States, 29464
MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
United States, Virginia
Virginia Oncology Associates
Hampton, Virginia, United States, 23666
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Oncology Associates
Virginia Beach, Virginia, United States, 23456
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
St George Private Hospital
Kogarah, New South Wales, Australia, 2217
Lismore Base Hospital, Lismore Cancer Care and Haematology Unit
Lismore, New South Wales, Australia, 2480
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
North Coast Cancer Institute
Port Macquarie, New South Wales, Australia, 2444
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital, Department of Medical Oncology
St Leonards, New South Wales, Australia, 2065
Sydney Adventist Hospital
Sydney, New South Wales, Australia, 2076
Australian Clinical Trials Pty Ltd
Wahroonga, New South Wales, Australia, 2076
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
PRP Cumberland Diagnostic Imaging
Wentworthville, New South Wales, Australia, 2145
Sydney West Cancer Trials Centre, Department of Medical Oncology
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Heart Care Partners
Auchenflower, Queensland, Australia, 4066
Icon Cancer Care Wesley
Auchenflower, Queensland, Australia, 4066
River City Pharmacy
Auchenflower, Queensland, Australia, 4066
Icon Cancer Care Chermside
Chermside, Queensland, Australia, 4032
University of Queensland Centre for Clinical Research (UQCCR)
Herston, Queensland, Australia, 4006
Nuclear Medicine and Imaging Department
Herston, Queensland, Australia, 4029
Icon Cancer Care South Brisbane
South Brisbane, Queensland, Australia, 4101
Mater Private Cardiology
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia, 5037
APHS Pharmacy
Kurralta Park, South Australia, Australia, 5037
Ashford Cancer Centre Research
Kurralta park, South Australia, Australia, 5037
Cancer Care SA Pty Ltd
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Bendigo Health, Bendigo Hospital
Bendigo, Victoria, Australia, 3550
Bendigo Health Medical Imaging
Bendigo, Victoria, Australia, 3552
Eastern Health
Box Hill, Victoria, Australia, 3128
MIA Box Hill Radiology
Box Hill, Victoria, Australia, 3128
Oncology Eastern Clinical Research Unit (ECRU)
Box Hill, Victoria, Australia, 3128
Pharmacy Department
Box Hill, Victoria, Australia, 3128
Cabrini Hospital Brighton
Brighton, Victoria, Australia, 3186
MIA Victoria
East Bentleigh, Victoria, Australia, 3165
Monash Cancer Centre
East Bentleigh, Victoria, Australia, 3165
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Western Hospital
Footscray, Victoria, Australia, 3011
Barwon Health, Geelong Hospital
Geelong, Victoria, Australia, 3220
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Cabrini Hospital Malvern
Malvern,, Victoria, Australia, 3144
Cabrini Radiology
Malvern, Victoria, Australia, 3144
MDI Chemer
Malvern, Victoria, Australia, 3144
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Austria
Krankenhaus der Barmherzigen Schwestern Linz
Linz, Austria, 4010
Ordination Dr. Fink
Salzburg, Austria, 5020
Salzburger Universitaetsklinikum
Salzburg, Austria, 5020
Medizinische Universitaet Wien
Wien, Austria, 1090
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
AZ Sint-Lucas
Ghent, Belgium, 9000
Jessaziekenhuis
Hasselt, Belgium, 3500
AZ Groeninge, Campus Sint Maarten
Kortrijk, Belgium, 8500
UZ Leuven - University Hospital Gasthuisberg
Leuven, Belgium, 3000
Centre Hospitalier Universitaire de Liege
Liege, Belgium, 4000
Canada, Alberta
Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Tom Baker Cancer Centre - Holy Cross Site
Calgary, Alberta, Canada, T2S 3C3
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency, Sindi Ahluwalia Hawkins, Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging
Victoria, British Columbia, Canada, V8R 1J8
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
Manitoba Prostate Centre
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
QEII Health Sciences Centre, Nova Scotia Cancer Centre.
Halifax, Nova Scotia, Canada, B3H 1V7
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V5C2
London RegCancer Program, London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital Cancer Centre, General Campus
Ottawa, Ontario, Canada, K1H8L6
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K2H 8P4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre Hospitalier de I'Universite de Montreal
Montreal, Quebec, Canada, H2L 4M1
Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec, Canada, G1R 2J6
Centre de recherche clinique el evaluative en oncologie (CRCEO)
Quebec, Canada, G1R 3S1
Denmark
Aalborg Hospital Nord
Aalborg, Denmark, 9100
Skejby Sygehus, Aarhus Universitetshospital
Aarhus N, Denmark, 8200
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Herlev Hospital
Herlev, Denmark, 2730
Rigshospitalet
kobenhavn O, Denmark, 2100
Roskilde Sygehus
Roskilde, Denmark, 4000
Finland
Docrates Clinic
Helsinki, Finland, 00180
Helsinki University Central Hospital
Helsinki, Finland, 00290
Oulu University Hospital
Oulu, Finland, 90220
Tampere University Hospital
Tampere, Finland, 33520
France
Hopital Civil
Strasbourg, Alsace, France, FR-67901
Centre Eugene Marquis-Service d'Oncologie Medicale
Rennes cedex, Bretagne, France, 35042
Institut Bergonie
Bordeaux, Nouvelle Aquitaine, France, FR-33076
Centre Regional de Lutte contre le Cancer Paul Papin
Angers Cedex 09, France, 49933
Clinique Rhone Durance
Avignon, France, 84000
Institut Bergonie
Bordeaux, France, FR-33076
CHD Vendee
La Roche sur Yon Cedex, France, 85925
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, France, 72000
Centre Leon Berard
Lyon, France, 69008 Cedex 08
Hopital Europeen Georges Pompidou
Paris Cedex 15, France, 75908
Institut Curie
Paris, France, 75005
Groupe Hospitalier La Pitie Salpetriere
Paris, France, 75013
Centre Rene Gauducheau
Saint Herblain Cedex, France, 44805
HIA Begin, Service de Medecine Interne et Oncologie
Saint-Mande, France, FR-94160
Institut de Cancerologie Lucien Neuwirth
Saint-Priest en Jarez, France, 42271
Clinique Pasteur
Toulouse, France, 31300
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12200
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany, 38126
Universitaetsklinikum Carl Gustav Carus Dresden an der
Dresden, Germany, 01307
Martini-Klinik am UKE Gmbh
Hamburg, Germany, 20246
Urologikum Hamburg
Hamburg, Germany, 22399
Universitaetsklinikum Heidelberg, Klinik Fuer Urologie
Heidelberg, Germany, 69120
Universitaetsklinikum des Saarlandes
Homburg/Saar, Germany, 66424
Universitaetsklinikum Mannheim, Klinik fuer Urologie
Mannheim, Germany, 68167
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie
Tuebingen, Germany, 72076
Universitaetsklinikum Ulm
Ulm, Germany, 89075
Kliniken Nordoberpfalz AG, Klinikum Weiden
Weiden in der Oberpfalz, Germany, 92637
Israel
Soroka University Medical Center
Beer Sheva, Israel, 84101
Assaf Harofe Medical Center
Beer Yaakov, Israel, 70300
Bnai Zion Medical Center
Haifa, Israel, 31048
Rabin Medical Center
Petach Tikva, Israel, 49100
The Chaim Sheba Medical Center
Ramat Gan, Israel, 52621
Italy
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, CR, Italy, 26100
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, FC, Italy, 47014
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, TO, Italy, 10043
Azienda USL8-Presidio Ospedaliero S.Donato
Arezzo, Italy, 52100
Ospedale G.B. Morgagni
Forli, Italy, 47100
Azienda Ospedaliera San. Camillo Forlanini
Rome, Italy, 00152
Japan
Kyushu University Hospital
Fukuoka-shi, Fukuoka, Japan, 8128582
Yokohama City University Hospital
Yokohama-shi, Kanagawa-ken, Japan, 2360004
Tohoku University Hospital
Sendai-Shi, Miyagi, Japan, 9800872
Nagasaki University Hospital
Nagasaki-shi, Nagasaki, Japan, 8528501
Kindai University Hospital
Osaka-sayama, Osaka, Japan, 5898511
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka-shi, Osaka, Japan, 5378511
Osaka University Hospital
Suita-shi, Osaka, Japan, 5650871
Tokushima University Hospital
Tokushima-shi, Tokushima, Japan, 7708503
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 1738610
Cancer Institute Hospital
Koutou-ku, Tokyo, Japan, 1358550
Kyorin University Hospital
Mitaka-shi, Tokyo, Japan, 181 8611
Showa University Hospital
Shinagawa-ku, Tokyo, Japan, 1428666
Keio University Hospital
Shinjyuku-ku, Tokyo, Japan, 1608582
Yamaguchi University Hospital
Ube-shi, Yamaguchi, Japan, Japan, 7558505
Chiba Cancer Center
Chiba, Japan, 2608717
Kyoto University Hospital
Kyoto, Japan, 6068507
Niigata University Medical and Dental Hospital
Niigata, Japan, 9518520
Osaka City University Hospital
Osaka, Japan, 5450051
Jikei University Hospital
Tokyo, Japan, 1058471
Nippon Medical School Hospital
Tokyo, Japan, 1138603
Yamagata Prefectural Central Hospital
Yamagata, Japan, 9902292
Korea, Republic of
National Cancer Center
Goyang, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonnam-do, Korea, Republic of, 58128
Samsung Medical Center
Gangnam-gu, Seoul, Korea, Republic of, 135 710
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of, 138-736
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 06273
Lithuania
Klaipeda University Hospital
Klaipeda, Lithuania, 92288
Division of Oncourology, National Cancer Institute
Vilnius, Lithuania, 08660
Netherlands
Vrije Universiteit Medical Center, Department of Medical Oncology
Amsterdam, Netherlands, 1081 HV
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
University Medical Center Groningen, Department of Urology
Groningen, Netherlands, 9713 GZ
UMC St. Radboud
Nijmegen, Netherlands, 6525 GA
Poland
EMC Instytut Medyczny S.A.
Wroclaw, Dolnoslaskie, Poland, 54-144
Wojewodzki Szpital Specjalistyczny. im. M. Kopernika
Lodz, Lodzkie, Poland, 93-509
Apteka Szpitalna
Gdansk, Pomorskie, Poland, 80-214
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomorskie, Poland, 80-952
Niepubliczny Zaklad Opieki Zdrowotnej
Myslowice, Slaskie, Poland, 41-400
Wielkopolskie Centrum Onkologii
Poznan, Wielkopolskie, Poland, 61-866
Russian Federation
Russian Academy of Medical Sciences Institution
Moscow, Russian Federation, 115478
State Educational Institution of Higher Professional Education
St-Petersburg, Russian Federation, 197022
North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare
St.-Petersburg, Russian Federation, 191015
Singapore
Department of Urology, National University Hospital
Singapore, Singapore, 119074
Singapore General Hospital
Singapore, Singapore, 169608
Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica
Banska Bystrica, Slovakia, 975 17
CUIMED s.r.o.
Bratislava, Slovakia, 851 05
Univerzitna Nemocnica Martin
Martin, Slovakia, 036 59
UROEXAM, spol. s r.o. urologicka ambulancia
Nitra, Slovakia, 949 01
Poliklinika Sekcov, wesper, s.r.o.
Presov, Slovakia, 080 01
UROCENTRUM MILAB s.r.o.
Presov, Slovakia, 080 01
Spain
Hospital Universitario German Trias i Pujol
Badalona, Barcelona, Spain, 08916
Althaia Xarxa Asistencial Manresa
Manresa, Barcelona, Spain, 08243
Hospital Son Espases
Palma de Mallorca, Islas Baleares, Spain, 07010
Clínica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Complejo Hospitalario Universitario A Coruna
A Coruna, Spain, 15006
Hospital del Mar
Barcelona, Spain, 08003
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Madrid Norte Sanchinarro
Madrid, Spain, 28050
Corporacio Sanitaria Parc Tauli
Sabadell(Barcelona), Spain, 08208
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, SE-413 45
Skane University Hospital
Malmo, Sweden, SE-205 02
Orebro University Hospital
Orebro, Sweden, se-701 85
Karolinska University Hospital Solna
Stockholm, Sweden, SE-171 76
Umea University Hospital
Umea, Sweden, SE-901 85
United Kingdom
Bishops Wood Hospital
Northwood, Middlesex, United Kingdom, HA6 2JW
Mount Vernon Hospital
Northwood, Middlesex, United Kingdom, HA6 2RN
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Northern Centre for Cancer Care
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Velindre Cancer Centre
Cardiff, Wales, United Kingdom, CF14 2TL
Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, Merseyside, United Kingdom, CH63 4JY
Clinical Investigations and Research Unit, Royal Sussex County Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS2 8ED
Edinburgh Cancer Centre
Edinburgh, United Kingdom, EH4 2XU
University College London Hospital NHS Trust
London, United Kingdom, NW1 2PG
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Pfizer
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01212991     History of Changes
Other Study ID Numbers: MDV3100-03
2010-020821-41 ( EudraCT Number )
C3431003 ( Other Identifier: Alias Study Number )
First Submitted: September 29, 2010
First Posted: October 1, 2010
Results First Submitted: October 8, 2014
Results First Posted: October 16, 2014
Last Update Posted: October 4, 2017
Last Verified: September 2017

Keywords provided by Pfizer:
Progressive Metastatic Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases