AzTrials
AzTrials

Prostate CancerPhase 3PREVAILNCT01212991

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

A Phase 3 study testing Enzalutamide in people with Prostate Cancer, run by Pfizer at 269 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,717 participants
Where
269 sitesin 22 countries
Study dates
16 Sep 2010to 14 Feb 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

269 sites in 22 countries.

269 sites in 22 countries

United States65 sites

  • Anschutz Cancer Center Pavilion Pharmacy

    Aurora, Colorado, 80045

  • University of Colorado Hospital, Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Lynn Cancer Institute Center for Hematology Oncology

    Boca Raton, Florida, 33486

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaoness Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Cancer Centers of North Carolina

    Cary, North Carolina, 27518

  • Hematology / Oncology MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Medical University of South Carolina - Urology Services

    Charleston, South Carolina, 29425

  • MUSC Department of Radiology

    Charleston, South Carolina, 29425

  • MUSC Urology Ambulatory Care

    Charleston, South Carolina, 29425

  • Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Levine Cancer Institute - Main

    Charlotte, North Carolina, 28204

  • Levine Cancer Institute - Southpark

    Charlotte, North Carolina, 28211

  • Levine Cancer Institute - University

    Charlotte, North Carolina, 28262

  • Levine Cancer Institute - Ballantyne

    Charlotte, North Carolina, 28277

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Barnes-Jewish St. Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Barnes-Jewish West County Hospital

    Creve Coeur, Missouri, 63141

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Investigational Chemotherapy Services

    Durham, North Carolina, 27710

  • Karmanos Cancer Institute Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Cancer Center Oncology Medical Group

    La Mesa, California, 91942

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • LAC&USC Medical Center

    Los Angeles, California, 90033

  • USC/Norris Comprehensive Cancer Center / Investigational Drug Services

    Los Angeles, California, 90033

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services

    Los Angeles, California, 90095

  • UCLA Clark Urology Clinic

    Los Angeles, California, 90095

  • Jewish Hospital & St. Mary's Healthcare, Inc.

    Louisville, Kentucky, 40245

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor

    Mt. Pleasant, South Carolina, 29464

  • MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor

    Mt. Pleasant, South Carolina, 29464

  • The Mount Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • North County Oncology Medical Clinic, Inc

    Oceanside, California, 92056

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Portland VA Medical Center Laboratory

    Portland, Oregon, 97239

  • Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • UC Davis Medical Center

    Sacramento, California, 95817

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Medical Oncology Associates-SD

    San Diego, California, 92123

  • Sharp Memorial Hospital Investigational Pharmacy

    San Diego, California, 92123

  • Sharp Rees-Stealy

    San Diego, California, 92123

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • BJH Pharmacy

    St Louis, Missouri, 63108

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • The University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • The University of Arizona Cancer Certer-North Campus

    Tucson, Arizona, 85719

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

Other trials in United States

Australia42 sites

  • Heart Care Partners

    Auchenflower, Queensland, 4066

  • Icon Cancer Care Wesley

    Auchenflower, Queensland, 4066

  • River City Pharmacy

    Auchenflower, Queensland, 4066

  • Bendigo Health, Bendigo Hospital

    Bendigo, Victoria, 3550

  • Bendigo Health Medical Imaging

    Bendigo, Victoria, 3552

  • Eastern Health

    Box Hill, Victoria, 3128

  • MIA Box Hill Radiology

    Box Hill, Victoria, 3128

  • Oncology Eastern Clinical Research Unit (ECRU)

    Box Hill, Victoria, 3128

  • Pharmacy Department

    Box Hill, Victoria, 3128

  • Cabrini Hospital Brighton

    Brighton, Victoria, 3186

  • Icon Cancer Care Chermside

    Chermside, Queensland, 4032

  • Monash Health Translation Precinct

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • Barwon Health, Geelong Hospital

    Geelong, Victoria, 3220

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • University of Queensland Centre for Clinical Research (UQCCR)

    Herston, Queensland, 4006

  • Nuclear Medicine and Imaging Department

    Herston, Queensland, 4029

  • St George Private Hospital

    Kogarah, New South Wales, 2217

  • Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037

  • APHS Pharmacy

    Kurralta Park, South Australia, 5037

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Cancer Care SA Pty Ltd

    Kurralta Park, South Australia, 5037

  • Lismore Base Hospital, Lismore Cancer Care and Haematology Unit

    Lismore, New South Wales, 2480

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144

  • Cabrini Radiology

    Malvern, Victoria, 3144

  • MDI Chemer

    Malvern, Victoria, 3144

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • North Coast Cancer Institute

    Port Macquarie, New South Wales, 2444

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Icon Cancer Care South Brisbane

    South Brisbane, Queensland, 4101

  • Icon Cancer Foundation

    South Brisbane, Queensland, 4101

  • Mater Private Cardiology

    South Brisbane, Queensland, 4101

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Royal North Shore Hospital, Department of Medical Oncology

    St Leonards, New South Wales, 2065

  • Sydney Adventist Hospital

    Sydney, New South Wales, 2076

  • Australian Clinical Trials Pty Ltd

    Wahroonga, New South Wales, 2076

  • SAN Pathology

    Wahroonga, New South Wales, 2076

  • SAN Radiology

    Wahroonga, New South Wales, 2076

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Japan21 sites

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 1138603

  • Chiba Cancer Center

    Chiba, 2608717

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 8128582

  • Cancer Institute Hospital

    Koutou-ku, Tokyo, 1358550

  • Kyoto University Hospital

    Kyoto, 6068507

  • Kyorin University Hospital

    Mitaka-shi, Tokyo, 181 8611

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 8528501

  • Niigata University Medical and Dental Hospital

    Niigata, 9518520

  • Osaka International Cancer Institute

    Osaka, Osaka, 5418567

  • Osaka City University Hospital

    Osaka, 5450051

  • Kindai University Hospital

    Ōsaka-sayama, Osaka, 5898511

  • Tohoku University Hospital

    Sendai, Miyagi, 9800872

  • Showa University Hospital

    Shinagawa-ku, Tokyo, 1428666

  • Keio University Hospital

    Shinjyuku-ku, Tokyo, 1608582

  • Osaka University Hospital

    Suita-shi, Osaka, 5650871

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 1738610

  • Tokushima University Hospital

    Tokushima, Tokushima, 7708503

  • Jikei University Hospital

    Tokyo, 1058471

  • Yamaguchi University Hospital

    Ube-shi, Yamaguchi, 7558505

  • Yamagata Prefectural Central Hospital

    Yamagata, 9902292

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 2360004

Other trials in Japan

Canada20 sites

  • Alberta Health Services - Cancer Care, Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Tom Baker Cancer Centre - Holy Cross Site

    Calgary, Alberta, T2S 3C3

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Centre, Nova Scotia Cancer Centre.

    Halifax, Nova Scotia, B3H 1V7

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V5C2

  • British Columbia Cancer Agency, Sindi Ahluwalia Hawkins, Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London RegCancer Program, London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L 4M1

  • The Ottawa Hospital Cancer Centre, General Campus

    Ottawa, Ontario, K1H8L6

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K2H 8P4

  • CHU de Quebec - L'Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Centre de recherche clinique el evaluative en oncologie (CRCEO)

    Québec, Quebec, G1R 3S1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • Vancouver Prostate Centre

    Vancouver, British Columbia, V5Z 1M9

  • Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging

    Victoria, British Columbia, V8R 1J8

  • British Columbia Cancer Agency - Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5

  • Manitoba Prostate Centre

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

France17 sites

  • ICO Paul Papin

    Angers, 49055

  • Clinique Rhone Durance

    Avignon, 84000

  • Institut Bergonie

    Bordeaux, New Aquitaine, FR-33076

  • Institut Bergonie

    Bordeaux, FR-33076

  • CHD Vendee

    La Roche-sur-Yon, 85925

  • Centre Jean Bernard - Clinique Victor Hugo

    Le Mans, 72000

  • Centre Leon Berard

    Lyon, 69008 Cedex 08

  • Institut Curie

    Paris, 75005

  • Groupe Hospitalier La Pitie Salpetriere

    Paris, 75013

  • Hopital Europeen Georges Pompidou

    Paris, 75908

  • Centre Eugene Marquis-Service d'Oncologie Medicale

    Rennes, Brittany Region, 35042

  • Centre de Recherche Clinique

    Saint-Herblain, 44805

  • HIA Begin, Service de Medecine Interne et Oncologie

    Saint-Mandé, FR-94160

  • Institut de Cancerologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • Hopital Civil

    Strasbourg, Alsace, FR-67901

  • Clinique Pasteur

    Toulouse, 31300

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany13 sites

  • Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 12200

  • Staedtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38126

  • Universitaetsklinikum Carl Gustav Carus Dresden an der

    Dresden, 01307

  • Martini-Klinik am UKE Gmbh

    Hamburg, 20246

  • Urologikum Hamburg

    Hamburg, 22399

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Heidelberg, Klinik Fuer Urologie

    Heidelberg, 69120

  • Universitaetsklinikum des Saarlandes

    Homburg/Saar, 66424

  • Universitaetsklinikum Mannheim, Klinik fuer Urologie

    Mannheim, 68167

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie

    Tübingen, 72076

  • Universitaetsklinikum Ulm

    Ulm, 89075

  • Kliniken Nordoberpfalz AG, Klinikum Weiden

    Weiden in Der Oberpfalz, 92637

Other trials in Germany

United Kingdom13 sites

  • Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Wirral, Merseyside, CH63 4JY

  • Clinical Investigations and Research Unit, Royal Sussex County Hospital

    Brighton, East Sussex, BN2 5BE

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS2 8ED

  • Velindre Cancer Centre

    Cardiff, Wales, CF14 2TL

  • Edinburgh Cancer Centre

    Edinburgh, EH4 2XU

  • University College London Hospital NHS Trust

    London, NW1 2PG

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

  • Northern Centre for Cancer Care

    Newcastle upon Tyne, TYNE and WEAR, NE7 7DN

  • Bishops Wood Hospital

    Northwood, Middlesex, HA6 2JW

  • Mount Vernon Hospital

    Northwood, Middlesex, HA6 2RN

  • Oxford University Hospitals NHS Trust

    Oxford, Oxfordshire, OX3 7LJ

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Spain11 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Hospital Universitario German Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050

  • Althaia Xarxa Asistencial Manresa

    Manresa, Barcelona, 08243

  • Hospital Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Corporacio Sanitaria Parc Tauli

    Sabadell(Barcelona), 08208

Other trials in Spain

South Korea7 sites

  • Samsung Medical Center

    Gangnam-gu, Seoul, 06351

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun-eup, Hwasun-gun, Jeollanam-do, 619763

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

  • Asan Medical Center

    Songpa-gu, Seoul, 05505

Other trials in South Korea

Belgium6 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • AZ Sint-Lucas

    Ghent, 9000

  • Jessaziekenhuis

    Hasselt, 3500

  • AZ Groeninge, Campus KL

    Kortrijk, 8500

  • UZ Leuven - University Hospital Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege-Urologie

    Liège, 4000

Other trials in Belgium

Denmark6 sites

  • Aalborg Hospital Nord

    Aalborg, 9100

  • Aarhus Universitetshospital

    Aarhus N, 8200

  • Rigshospitalet

    Copenhagen, 2200

  • Frederiksberg Hospital

    Frederiksberg, 2000

  • Herlev Hospital

    Herlev, 2730

  • Roskilde Sygehus

    Roskilde, 4000

Other trials in Denmark

Italy6 sites

  • Azienda USL8-Presidio Ospedaliero S.Donato

    Arezzo, 52100

  • Azienda Socio Sanitaria Territoriale di Cremona

    Cremona, CR, 26100

  • Ospedale G.B. Morgagni

    Forlì, 47100

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

    Meldola, FC, 47014

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, TO, 10043

  • Azienda Ospedaliera San. Camillo Forlanini

    Rome, 00152

Other trials in Italy

Poland6 sites

  • Apteka Szpitalna

    Gdansk, Pomeranian Voivodeship, 80-214

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-952

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Tramatologii im. M.Kopernika w Lodzi

    Lodz, Łódź Voivodeship, 93-509

  • Niepubliczny Zaklad Opieki Zdrowotnej

    Mysłowice, Silesian Voivodeship, 41-400

  • Wielkopolskie Centrum Onkologii

    Poznan, Greater Poland Voivodeship, 61-866

  • EMC Instytut Medyczny S.A.

    Wroclaw, Lower Silesian Voivodeship, 54-144

Other trials in Poland

Slovakia6 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica

    Banská Bystrica, 975 17

  • CUIMED s.r.o.

    Bratislava, 851 05

  • Univerzitna Nemocnica Martin

    Martin, 036 59

  • UROEXAM, spol. s r.o. urologicka ambulancia

    Nitra, 949 01

  • Poliklinika Sekcov, wesper, s.r.o.

    Prešov, 080 01

  • UROCENTRUM MILAB s.r.o.

    Prešov, 080 01

Other trials in Slovakia

Israel5 sites

  • Assaf Harofe Medical Center

    Beer Yaakov, 70300

  • Soroka University Medical Center

    Beersheba, 84101

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rabin Medical Center

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

Sweden5 sites

  • Sahlgrenska University Hospital

    Gothenburg, SE-413 45

  • Skane University Hospital

    Malmö, SE-205 02

  • Orebro University Hospital

    Örebro, se-701 85

  • Karolinska University Hospital Solna

    Stockholm, SE-171 76

  • Umea University Hospital

    Umeå, SE-901 85

Other trials in Sweden

Austria4 sites

  • Krankenhaus der Barmherzigen Schwestern Linz

    Linz, 4010

  • Ordination Dr. Fink

    Salzburg, 5020

  • Salzburger Universitatsklinikum

    Salzburg, 5020

  • Medizinische Universitaet Wien

    Vienna, 1090

Other trials in Austria

Finland4 sites

  • Docrates Clinic

    Helsinki, 00180

  • Helsinki University Central Hospital

    Helsinki, 00290

  • Oulu University Hospital

    Oulu, 90220

  • Tampere University Hospital

    Tampere, 33520

Other trials in Finland

Netherlands4 sites

  • Vrije Universiteit Medical Center, Department of Medical Oncology

    Amsterdam, 1081 HV

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • University Medical Center Groningen, Department of Urology

    Groningen, 9713 GZ

  • UMC St. Radboud

    Nijmegen, 6525 GA

Other trials in Netherlands

Russia4 sites

  • Russian Academy of Medical Sciences Institution

    Moscow, 115478

  • North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare

    Saint Petersburg, 191015

  • State Educational Institution of Higher Professional Education

    Saint Petersburg, 197022

  • State healthcare institute

    Saint Petersburg, 197758

Other trials in Russia

Lithuania2 sites

  • Klaipeda University Hospital

    Klaipėda, 92288

  • Division of Oncourology, National Cancer Institute

    Vilnius, 08660

Other trials in Lithuania

Singapore2 sites

  • Department of Urology, National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

About this study

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

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.

Conditions
Prostate Cancer
Being tested
Enzalutamide, Placebo
Keywords
Progressive Metastatic Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnzalutamideDrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT01212991
Study groupRoleWhat they receive
EnzalutamideExperimentalNot described
Receives: Drug: Enzalutamide
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    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.

    Measured: During study period (up to 3 years)

  2. Radiographic Progression-free Survival (rPFS)

    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.

    Measured: During study period (up to 20 months)

Secondary outcomes (5)

  1. Time to First Skeletal-related Event

    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.

    Measured: During study period (up to 3 years)

  2. Time to Initiation of Cytotoxic Chemotherapy

    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.

    Measured: During study period (up to 3 years)

  3. Time to Prostate-specific Antigen (PSA) Progression

    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.

    Measured: During study period (up to 3 years)

  4. Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%

    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.

    Measured: During study period (up to 3 years)

  5. Best Overall Soft Tissue Response

    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.

    Measured: During study period (up to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2010 (estimated)
  2. Study start16 Sep 2010
  3. Primary completion30 Sep 2013
  4. Study completion14 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,717 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01212991
Sponsor's protocol ID
MDV3100-03
Other IDs
2010-020821-41, C3431003
Acronym
PREVAIL
Status last verified
Mar 2020
First submitted
29 Sep 2010
Last updated
17 Mar 2020
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.

    PubMed 35731340

  • Joshua AM, Armstrong A, Crumbaker M, Scher HI, de Bono J, Tombal B, Hussain M, Sternberg CN, Gillessen S, Carles J, Fizazi K, Lin P, Duggan W, Sugg J, Russell D, Beer TM. Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER. Eur J Cancer. 2022 Jul;170:285-295. doi: 10.1016/j.ejca.2022.04.005. Epub 2022 May 26.

    PubMed 35643841

  • Tombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):288-295. doi: 10.1038/s41391-021-00447-9. Epub 2021 Sep 13.

    PubMed 34518652

  • Armstrong AJ, Lin P, Tombal B, Saad F, Higano CS, Joshua AM, Parli T, Rosbrook B, van Os S, Beer TM. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol. 2020 Sep;78(3):347-357. doi: 10.1016/j.eururo.2020.04.061. Epub 2020 Jun 9.

    PubMed 32527692

  • Armstrong AJ, Al-Adhami M, Lin P, Parli T, Sugg J, Steinberg J, Tombal B, Sternberg CN, de Bono J, Scher HI, Beer TM. Association Between New Unconfirmed Bone Lesions and Outcomes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide: Secondary Analysis of the PREVAIL and AFFIRM Randomized Clinical Trials. JAMA Oncol. 2020 Feb 1;6(2):217-225. doi: 10.1001/jamaoncol.2019.4636.

    PubMed 31830211

  • Armstrong AJ, Lin P, Higano CS, Iversen P, Sternberg CN, Tombal B, Phung D, Parli T, Krivoshik A, Beer TM. Prognostic Association of Prostate-specific Antigen Decline with Clinical Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide in a Randomized Clinical Trial. Eur Urol Oncol. 2019 Nov;2(6):677-684. doi: 10.1016/j.euo.2018.11.005. Epub 2018 Dec 3.

    PubMed 31274110

  • Armstrong AJ, Lin P, Higano CS, Sternberg CN, Sonpavde G, Tombal B, Templeton AJ, Fizazi K, Phung D, Wong EK, Krivoshik A, Beer TM. Development and validation of a prognostic model for overall survival in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Ann Oncol. 2018 Nov 1;29(11):2200-2207. doi: 10.1093/annonc/mdy406.

    PubMed 30202945

  • Rathkopf DE, Beer TM, Loriot Y, Higano CS, Armstrong AJ, Sternberg CN, de Bono JS, Tombal B, Parli T, Bhattacharya S, Phung D, Krivoshik A, Scher HI, Morris MJ. Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):694-701. doi: 10.1001/jamaoncol.2017.5808.

    PubMed 29522174

  • Kim CS, Choi YD, Lee SE, Lee HM, Ueda T, Yonese J, Fukagai T, Chiong E, Lau W, Abhyankar S, Theeuwes A, Tombal B, Beer TM, Kimura G. Post hoc analyses of East Asian patients from the randomized placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer. Medicine (Baltimore). 2017 Jul;96(27):e7223. doi: 10.1097/MD.0000000000007223.

    PubMed 28682871

  • Devlin N, Herdman M, Pavesi M, Phung D, Naidoo S, Beer TM, Tombal B, Loriot Y, Ivanescu C, Parli T, Balk M, Holmstrom S. Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial. Health Qual Life Outcomes. 2017 Jun 23;15(1):130. doi: 10.1186/s12955-017-0704-y.

    PubMed 28645287

  • Bryce AH, Alumkal JJ, Armstrong A, Higano CS, Iversen P, Sternberg CN, Rathkopf D, Loriot Y, de Bono J, Tombal B, Abhyankar S, Lin P, Krivoshik A, Phung D, Beer TM. Radiographic progression with nonrising PSA in metastatic castration-resistant prostate cancer: post hoc analysis of PREVAIL. Prostate Cancer Prostatic Dis. 2017 Jun;20(2):221-227. doi: 10.1038/pcan.2016.71. Epub 2017 Jan 24.

    PubMed 28117385

  • Beer TM, Armstrong AJ, Rathkopf D, Loriot Y, Sternberg CN, Higano CS, Iversen P, Evans CP, Kim CS, Kimura G, Miller K, Saad F, Bjartell AS, Borre M, Mulders P, Tammela TL, Parli T, Sari S, van Os S, Theeuwes A, Tombal B. Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study. Eur Urol. 2017 Feb;71(2):151-154. doi: 10.1016/j.eururo.2016.07.032. Epub 2016 Jul 28.

    PubMed 27477525

  • Kim CS, Theeuwes A, Kwon DD, Choi YD, Chung BH, Lee HM, Lee KH, Lee SE. The PREVAIL trial of enzalutamide in men with chemotherapy-naive, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients. Investig Clin Urol. 2016 May;57(3):174-83. doi: 10.4111/icu.2016.57.3.174. Epub 2016 May 10.

    PubMed 27195316

  • Graff JN, Baciarello G, Armstrong AJ, Higano CS, Iversen P, Flaig TW, Forer D, Parli T, Phung D, Tombal B, Beer TM, Sternberg CN. Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL. Ann Oncol. 2016 Feb;27(2):286-94. doi: 10.1093/annonc/mdv542. Epub 2015 Nov 16.

    PubMed 26578735

  • Loriot Y, Miller K, Sternberg CN, Fizazi K, De Bono JS, Chowdhury S, Higano CS, Noonberg S, Holmstrom S, Mansbach H, Perabo FG, Phung D, Ivanescu C, Skaltsa K, Beer TM, Tombal B. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial. Lancet Oncol. 2015 May;16(5):509-21. doi: 10.1016/S1470-2045(15)70113-0. Epub 2015 Apr 14.

    PubMed 25888263

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enzalutamide in people with Prostate Cancer, run by Pfizer at 269 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 269 sites in United States, Australia, Japan, Canada, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: During study period (up to 3 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01212991, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.

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