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

March 12, 2020 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1717

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australia, 2217
        • St George private Hospital
      • Lismore, New South Wales, Australia, 2480
        • Lismore Base Hospital, Lismore Cancer Care and Haematology Unit
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Port Macquarie, New South Wales, Australia, 2444
        • North Coast Cancer Institute
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital, Department of Medical Oncology
      • Sydney, New South Wales, Australia, 2076
        • Sydney Adventist Hospital
      • Wahroonga, New South Wales, Australia, 2076
        • Australian Clinical Trials Pty Ltd
      • Wahroonga, New South Wales, Australia, 2076
        • SAN Pathology
      • Wahroonga, New South Wales, Australia, 2076
        • SAN Radiology
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater NewCastle
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Heart Care Partners
      • Auchenflower, Queensland, Australia, 4066
        • Icon Cancer Care Wesley
      • Auchenflower, Queensland, Australia, 4066
        • River City Pharmacy
      • Chermside, Queensland, Australia, 4032
        • Icon Cancer Care Chermside
      • Herston, Queensland, Australia, 4006
        • University of Queensland Centre for Clinical Research (UQCCR)
      • Herston, Queensland, Australia, 4029
        • Nuclear Medicine and Imaging Department
      • South Brisbane, Queensland, Australia, 4101
        • Icon Cancer Care South Brisbane
      • South Brisbane, Queensland, Australia, 4101
        • Icon Cancer Foundation
      • South Brisbane, Queensland, Australia, 4101
        • Mater Private Cardiology
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Adelaide Cancer Centre
      • Kurralta Park, South Australia, Australia, 5037
        • APHS Pharmacy
      • Kurralta Park, South Australia, Australia, 5037
        • Cancer Care SA Pty Ltd
      • Kurralta park, South Australia, Australia, 5037
        • Ashford Cancer Centre Research
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Bendigo Health, Bendigo Hospital
      • Bendigo, Victoria, Australia, 3552
        • Bendigo Health Medical Imaging
      • Box Hill, Victoria, Australia, 3128
        • 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
      • Brighton, Victoria, Australia, 3186
        • Cabrini Hospital Brighton
      • Clayton, Victoria, Australia, 3168
        • Monash Health Translation Precinct
      • East Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Centre
      • Geelong, Victoria, Australia, 3220
        • Barwon Health, Geelong Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Malvern, Victoria, Australia, 3144
        • Cabrini Radiology
      • Malvern, Victoria, Australia, 3144
        • MDI Chemer
      • Malvern,, Victoria, Australia, 3144
        • Cabrini Hospital Malvern
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
      • St Albans, Victoria, Australia, 3021
        • Sunshine Hospital
  • Austria
      • Linz, Austria, 4010
        • Krankenhaus der Barmherzigen Schwestern Linz
      • Salzburg, Austria, 5020
        • Ordination Dr. Fink
      • Salzburg, Austria, 5020
        • Salzburger Universitatsklinikum
      • Wien, Austria, 1090
        • Medizinische Universitaet Wien
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Ghent, Belgium, 9000
        • AZ Sint-Lucas
      • Hasselt, Belgium, 3500
        • Jessaziekenhuis
      • Kortrijk, Belgium, 8500
        • AZ Groeninge, Campus KL
      • Leuven, Belgium, 3000
        • UZ Leuven - University Hospital Gasthuisberg
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire de Liege-Urologie
  • Canada
      • Quebec, Canada, G1R 2J6
        • CHU de Quebec - L'Hotel-Dieu de Quebec
      • Quebec, Canada, G1R 3S1
        • Centre de recherche clinique el evaluative en oncologie (CRCEO)
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
      • Calgary, Alberta, Canada, T2S 3C3
        • Tom Baker Cancer Centre - Holy Cross Site
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • British Columbia Cancer Agency, Sindi Ahluwalia Hawkins, Centre for the Southern Interior
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Prostate Centre
      • Victoria, British Columbia, Canada, V8R 1J8
        • Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging
      • Victoria, British Columbia, Canada, V8R 6V5
        • British Columbia Cancer Agency - Vancouver Island Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Manitoba Prostate Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Sciences Centre
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • QEII Health Sciences Centre, Nova Scotia Cancer Centre.
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • London, Ontario, Canada, N6A 4L6
        • London RegCancer Program, London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H8L6
        • The Ottawa Hospital Cancer Centre, General Campus
      • Ottawa, Ontario, Canada, K2H 8P4
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Universite de Montreal
  • Denmark
      • Aalborg, Denmark, 9100
        • Aalborg Hospital Nord
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital
      • Copenhagen, Denmark, 2200
        • Rigshospitalet
      • Frederiksberg, Denmark, 2000
        • Frederiksberg Hospital
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Roskilde, Denmark, 4000
        • Roskilde Sygehus
  • Finland
      • Helsinki, Finland, 00290
        • Helsinki University Central Hospital
      • Helsinki, Finland, 00180
        • Docrates Clinic
      • Oulu, Finland, 90220
        • Oulu University Hospital
      • Tampere, Finland, 33520
        • Tampere University Hospital
  • France
      • Angers, France, 49055
        • ICO Paul Papin
      • Avignon, France, 84000
        • Clinique Rhône Durance
      • Bordeaux, France, FR-33076
        • Institut Bergonie
      • La Roche sur Yon Cedex, France, 85925
        • CHD Vendée
      • Le Mans, France, 72000
        • Centre Jean Bernard - Clinique Victor Hugo
      • Lyon, France, 69008 Cedex 08
        • Centre Léon Bérard
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75013
        • Groupe Hospitalier la Pitié Salpêtrière
      • Paris Cedex 15, France, 75908
        • Hopital Europeen Georges Pompidou
      • Saint Herblain Cedex, France, 44805
        • Centre de Recherche Clinique
      • Saint-Mande, France, FR-94160
        • HIA Begin, Service de Medecine Interne et Oncologie
      • Saint-Priest en Jarez, France, 42271
        • institut de cancérologie Lucien Neuwirth
      • Toulouse, France, 31300
        • Clinique Pasteur
      • Villejuif, France, 94805
        • Institut Gustave Roussy
    • Alsace
      • Strasbourg, Alsace, France, FR-67901
        • Hôpital Civil
    • Bretagne
      • Rennes cedex, Bretagne, France, 35042
        • Centre Eugene Marquis-Service d'Oncologie Medicale
    • Nouvelle Aquitaine
      • Bordeaux, Nouvelle Aquitaine, France, FR-33076
        • Institut Bergonie
  • Germany
      • Berlin, Germany, 12200
        • Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
      • Braunschweig, Germany, 38126
        • Staedtisches Klinikum Braunschweig gGmbH
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden an der
      • Hamburg, Germany, 20246
        • Martini-Klinik am UKE GmbH
      • Hamburg, Germany, 22399
        • Urologikum Hamburg
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg, Klinik Fuer Urologie
      • Homburg/Saar, Germany, 66424
        • Universitaetsklinikum des Saarlandes
      • Mannheim, Germany, 68167
        • Universitaetsklinikum Mannheim, Klinik fuer Urologie
      • Muenster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Tuebingen, Germany, 72076
        • Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie
      • Ulm, Germany, 89075
        • Universitaetsklinikum Ulm
      • Weiden In Der Oberpfalz, Germany, 92637
        • Kliniken Nordoberpfalz AG, Klinikum Weiden
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka University Medical Center
      • Beer Yaakov, Israel, 70300
        • Assaf Harofe Medical Center
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
      • Ramat Gan, Israel, 52621
        • The Chaim Sheba Medical Center
  • Italy
      • Arezzo, Italy, 52100
        • Azienda USL8-Presidio Ospedaliero S.Donato
      • Forli, Italy, 47100
        • Ospedale G.B. Morgagni
      • Rome, Italy, 00152
        • Azienda Ospedaliera San. Camillo Forlanini
    • CR
      • Cremona, CR, Italy, 26100
        • Azienda Socio Sanitaria Territoriale di Cremona
    • FC
      • Meldola, FC, Italy, 47014
        • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
    • TO
      • Orbassano, TO, Italy, 10043
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
  • Japan
      • Chiba, Japan, 2608717
        • Chiba Cancer Center
      • Kyoto, Japan, 6068507
        • Kyoto University Hospital
      • Niigata, Japan, 9518520
        • Niigata University Medical and Dental Hospital
      • Osaka, Japan, 5450051
        • Osaka City University Hospital
      • Tokyo, Japan, 1058471
        • Jikei University Hospital
      • Yamagata, Japan, 9902292
        • Yamagata Prefectural Central Hospital
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 8128582
        • Kyushu University Hospital
    • Kanagawa-ken
      • Yokohama-shi, Kanagawa-ken, Japan, 2360004
        • Yokohama City University Hospital
    • Miyagi
      • Sendai-Shi, Miyagi, Japan, 9800872
        • Tohoku University Hospital
    • Nagasaki
      • Nagasaki-shi, Nagasaki, Japan, 8528501
        • Nagasaki University Hospital
    • Osaka
      • Osaka-sayama, Osaka, Japan, 5898511
        • Kindai University Hospital
      • Osaka-shi, Osaka, Japan, 5418567
        • Osaka International Cancer Institute
      • Suita-shi, Osaka, Japan, 5650871
        • Osaka University Hospital
    • Tokushima
      • Tokushima-shi, Tokushima, Japan, 7708503
        • Tokushima University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138603
        • Nippon Medical School Hospital
      • Itabashi-ku, Tokyo, Japan, 1738610
        • Nihon University Itabashi Hospital
      • Koutou-ku, Tokyo, Japan, 1358550
        • Cancer Institute Hospital
      • Mitaka-shi, Tokyo, Japan, 181 8611
        • Kyorin University Hospital
      • Shinagawa-ku, Tokyo, Japan, 1428666
        • Showa University Hospital
      • Shinjyuku-ku, Tokyo, Japan, 1608582
        • Keio University Hospital
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 7558505
        • Yamaguchi University Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital, Yonsei University Health System
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Jeonnam
      • Hwasun-eup, Hwasun-gun, Jeonnam, Korea, Republic of, 619763
        • Chonnam National University Hwasun Hospital
    • Seoul
      • Gangnam-gu, Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Songpa-gu, Seoul, Korea, Republic of, 05505
        • Asan Medical Center
  • Lithuania
      • Klaipeda, Lithuania, 92288
        • Klaipeda University Hospital
      • Vilnius, Lithuania, 08660
        • Division of Oncourology, National Cancer Institute
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Vrije Universiteit Medical Center, Department of Medical Oncology
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen, Department of Urology
      • Nijmegen, Netherlands, 6525 GA
        • UMC St. Radboud
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 54-144
        • EMC Instytut Medyczny S.A.
    • Lodzkie
      • Lodz, Lodzkie, Poland, 93-509
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Tramatologii im. M.Kopernika w Lodzi
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-214
        • Apteka Szpitalna
      • Gdansk, Pomorskie, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
    • Slaskie
      • Myslowice, Slaskie, Poland, 41-400
        • Niepubliczny Zaklad Opieki Zdrowotnej
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-866
        • Wielkopolskie Centrum Onkologii
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Russian Academy of Medical Sciences Institution
      • St-Petersburg, Russian Federation, 197022
        • State Educational Institution of Higher Professional Education
      • St-Petersburg, Russian Federation, 197758
        • State healthcare institute
      • St.-Petersburg, Russian Federation, 191015
        • North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 119074
        • Department of Urology, National University Hospital
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica
      • Bratislava, Slovakia, 851 05
        • CUIMED s.r.o.
      • Martin, Slovakia, 036 59
        • Univerzitna Nemocnica Martin
      • Nitra, Slovakia, 949 01
        • UROEXAM, spol. s r.o. urologicka ambulancia
      • Presov, Slovakia, 080 01
        • Poliklinika Sekcov, wesper, s.r.o.
      • Presov, Slovakia, 080 01
        • Urocentrum MILAB s.r.o.
  • Spain
      • A Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruna
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro
      • Sabadell(Barcelona), Spain, 08208
        • Corporació Sanitària Parc Taulí
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario German Trias i Pujol
      • Manresa, Barcelona, Spain, 08243
        • Althaia Xarxa Asistencial Manresa
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07010
        • Hospital Son Espases
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra
  • Sweden
      • Gothenburg, Sweden, SE-413 45
        • Sahlgrenska University Hospital
      • Malmo, Sweden, SE-205 02
        • Skåne University Hospital
      • Orebro, Sweden, SE-701 85
        • Orebro University Hospital
      • Stockholm, Sweden, SE-171 76
        • Karolinska University Hospital Solna
      • Umea, Sweden, SE-901 85
        • Umeå University Hospital
  • United Kingdom
      • Brighton, East Sussex, United Kingdom, BN2 5BE
        • Clinical Investigations and Research Unit, Royal Sussex County Hospital
      • Bristol, United Kingdom, BS2 8ED
        • University Hospitals Bristol NHS Foundation Trust
      • Edinburgh, United Kingdom, EH4 2XU
        • Edinburgh Cancer Centre
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom, NW1 2PG
        • University College London Hospital NHS Trust
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2JW
        • Bishops Wood Hospital
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
        • Oxford University Hospitals NHS Trust
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
    • Tyne and Wear
      • Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
        • Northern Centre for Cancer Care
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Velindre Cancer Centre
    • Wirral, Merseyside
      • Bebington, Wirral, Merseyside, United Kingdom, CH63 4JY
        • Clatterbridge Cancer Centre NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85719
        • The University of Arizona Cancer Center-North Campus
      • Tucson, Arizona, United States, 85719
        • The University of Arizona Cancer Certer-North Campus
    • California
      • La Mesa, California, United States, 91942
        • Cancer Center Oncology Medical Group
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • 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, 90095
        • UCLA Clark Urology Clinic
      • Oceanside, California, United States, 92056
        • North County Oncology Medical Clinic, Inc
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • 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
        • Medical Oncology Associates-SD
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Anschutz Cancer Center Pavilion Pharmacy
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital, Anschutz Cancer Pavilion
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Lynn Cancer Institute Center for Hematology Oncology
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Faculty Foundation
    • Kentucky
      • Louisville, Kentucky, United States, 40245
        • Jewish Hospital & St. Mary's Healthcare, Inc.
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaoness Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Karmanos Cancer Institute Weisberg Cancer Treatment Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Barnes-Jewish West County Hospital
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
      • Saint Louis, Missouri, United States, 63108
        • BJH Pharmacy
      • Saint Peters, Missouri, United States, 63376
        • Barnes-Jewish St. Peters Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10029
        • The Mount Sinai Medical Center
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Cancer Centers of North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Levine Cancer Institute
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute - Main
      • Charlotte, North Carolina, United States, 28211
        • Levine Cancer Institute - Southpark
      • Charlotte, North Carolina, United States, 28262
        • Levine Cancer Institute - University
      • Charlotte, North Carolina, United States, 28277
        • Levine Cancer Institute - Ballantyne
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27710
        • Investigational Chemotherapy Services
      • Raleigh, North Carolina, United States, 27607
        • Cancer Centers of North Carolina
    • Oregon
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center Laboratory
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • 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
      • Mount Pleasant, South Carolina, United States, 29464
        • 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
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas
    • Virginia
      • 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
        • Virginia Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During study period (up to 3 years)
Radiographic Progression-free Survival (rPFS)
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.
During study period (up to 20 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During study period (up to 3 years)
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.
During study period (up to 3 years)
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.
During study period (up to 3 years)
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.
During study period (up to 3 years)
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.
During study period (up to 3 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to a maximum of 6.5 years that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
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
Time Frame: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug up to a maximum duration of 6.5 years. Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to a maximum duration of 6.5 years that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2010

Primary Completion (Actual)

September 30, 2013

Study Completion (Actual)

February 14, 2019

Study Registration Dates

First Submitted

September 29, 2010

First Submitted That Met QC Criteria

September 30, 2010

First Posted (Estimate)

October 1, 2010

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDV3100-03
  • 2010-020821-41 (EudraCT Number)
  • C3431003 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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