Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

1,199

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

September 15, 2011

Study Completion Date

November 2, 2017

Conditions
Castration-Resistant Prostate Cancer
Interventions
DRUG

Enzalutamide

MDV3100, 160 mg orally per day

DRUG

Placebo

Placebo comparator

Trial Locations (249)

1090

ISOTOPIX Ambulatorium fuer, Vienna

Medical University of Vienna, Vienna

1200

Cliniques Universitaires Saint- Luc, Brussels

2031

Prince of Wales Hospital, Department of Medical Oncology, Randwick

2139

Sydney Cancer Centre, Concord

2145

PRP Diagnostic Imaging, Wentworthville

Sydney West Cancer Trials Centre, Department of Medical Oncology, Westmead

2199

Sandton Oncology Centre, Sandton

2444

Mid North Coast Diagnostic Imaging, Port Macquarie

Port Macquarie Base Hospital Pharmacy, Port Macquarie

Port Macquarie Base Hospital, Port Macquarie

2450

North Coast Cancer Institute, Coffs Harbour

2485

The Tweed Hospital, Tweed Heads

3000

University Hospital Gasthuisberg, Leuven

3011

60 Eleanor St, Footscray

Western Hospital, Footscray

3050

The Royal Melbourne Hospital, Victoria

3065

St. Vincent's Hospital Melbourne, Fitzroy

3084

Austin Hospital, Heidelberg

3199

Peninsula Oncology Centre, Frankston

3500

VZW Jessa Ziekenhuis, Hasselt

4001

Hopelands Cancer Centre, Durban

4010

Krankenhaus der Barmherzigen Schwestern Linz, Linz

4029

Cancer Care Services, Herston

4032

Icon Cancer Care Chermside, Chermside

Southern X-Ray Chermside, Chermside

4064

River City Pharmacy, Auchenflower

Icon Cancer Foundation, Milton

4066

Heart Care Partners, Auchenflower

Icon Cancer Care Wesley, Auchenflower

XRadiology, Toowong

4101

Icon Cancer Care South Brisbane, South Brisbane

Mater Private Cardiology, South Brisbane

Queensland X-Ray, South Brisbane

5000

Department of Medical Oncology, Adelaide

6009

Sir Charles Gairdner Hospital, Department of Medical Oncology, Nedlands

6045

GVI Oncology, Port Elizabeth

7000

Royal Hobart Hospital, Hobart

8300

Policlinico Neuquen, Neuquén

8324

Policlinico Modelo de Cipolletti, Cipolletti

8500

AZ Groeninge - Campus Kennedylaan, Kortrijk

AZ Groeninge - Campus Sint Maarten, Kortrijk

8800

H.-Hartziekenhuis Roeselare-Menen vzw, Roeselare

9000

AZ Sint- Lucas, Ghent

10021

Weill Cornell Medical College-New York Presbyterian Hospital, New York

10043

Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano

10065

Memorial Sloan-Kettering Cancer Center, New York

Weill Cornell Medical College-New York Presbyterian Hospital, New York

12200

Charite - Universitaetsmedizin Berlin-Campus Benjamin Franklin, Berlin

14076

Centre Regional Francois Baclesse de lutte contre le cancer, Caen

14263

Roswell Park Cancer Institute, Buffalo

15132

UPMC Cancer Centers, McKeesport

15232

University of Pittsburgh Cancer Institute, Pittsburgh

15237

UPMC Cancer Centers, Pittsburgh

15240

VA Pittsburgh Healthcare System, Pittsburgh

19104

Hospital of the University of Pennsylvania, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20037

George Washington University-Medical Faculty Associates, Washington D.C.

20246

Martini-Klinik am UKE GmbH, Hamburg

21231

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

21287

The Johns Hopkins Hospital, Baltimore

22391

Roentgenpraxis, Hamburg

22399

Urologische Gemeinschaftspraxis Poppenbuettel, Hamburg

23114

Virginia Cancer Institute, Midlothian

23188

Virginia Oncology Associates, Williamsburg

23230

Virginia Cancer Institute, Richmond

23320

Virginia Oncology Associates, Chesapeake

23456

Virginia Oncology Associates, Virginia Beach

23502

Virginia Oncology Associates, Norfolk

23606

Virginia Oncology Associates, Newport News

23666

Virginia Oncology Associates, Hampton

26100

"Azienda Ospedaliera Istituti Ospitalieri di Cremona", Cremona

27710

Duke University Medical Center, Durham

Pharmaceutical Research Services, Durham

28050

Hospital Madrid Norte Sanchinarro, Madrid

29425

Hollings Cancer Center, Charleston

Medical University of South Carolina (MUSC), Charleston

29572

Carolina Urologic Research Center, Myrtle Beach

Grand Strand Urology, Myrtle Beach

30318

Peachtree Hematology-Oncology Consultants, P.C., Atlanta

31008

Clinica Universidad de Navarra, Pamplona

33076

Institut Bergonie, Bordeaux

33401

Palm Beach Cancer Institute, West Palm Beach

33410

Palm Beach Cancer Institute, Palm Beach Gardens

33414

Palm Beach Cancer Institute, Wellington

33462

Palm Beach Cancer Institute, Atlantis

35233

University of Alabama at Birmingham, Birmingham

35294

University of Alabama at Birmingham, Birmingham

37055

Tennessee Oncology, PLLC, Dickson

37066

Tennessee Oncology, PLLC, Gallatin

37067

Tennessee Oncology, PLLC, Franklin

37076

Tennessee Oncology, PLLC, Hermitage

37087

Tennessee Oncology, PLLC, Lebanon

37129

Tennessee Oncology, PLLC, Murfreesboro

37167

Tennessee Oncology, PLLC, Smyrna

37203

Tennessee Oncology, PLLC, Nashville

The Sarah Cannon Research Institute, Nashville

37205

Tennessee Oncology, PLLC, Nashville

37207

Tennessee Oncology, PLLC, Nashville

37211

Tennessee Oncology, PLLC, Nashville

37404

Tennessee Oncology, PLLC, Chattanooga

38126

Staedtisches Klinikum Braunschweig gGmbH, Braunschweig

41100

Azienda Ospedaliero-Universitaria di Modena Policlinico, Via Del Pozzo 71

42030

Centre Hospitalier, Saint-Etienne

42055

Centre d'Investigation Clinique, (CIE3), Saint-Etienne

42271

Institut de Cancerologie de la Loire, Saint-Priest-en-Jarez

44805

Centre Rene Gauducheau, Saint-Herblain

48201

Karmanos Cancer Institute, Detroit

48334

Weisberg Cancer Treatment Center, Farmington Hills

49933

Centre Paul Papin, Angers

51056

Institut Jean Godinot, Reims

52074

Universitaetsklinikum Aachen, Aachen

53792

University of Wisconsin Hospital and Clinics, Madison

55905

Mayo Clinic, Rochester

60637

University of Chicago Medical Center, Chicago

University of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

63141

Siteman Cancer Center-West County, Creve Coeur

63376

Siteman Cancer Center, City of Saint Peters

68167

Universitaetsklinikum Mannheim, Mannheim

69003

Groupement Hospitalier Edouard Herriot - Pavillon V, Lyon

69120

Universitaetsklinikum Heidelberg, Heidelberg

69373

Centre Leon Berard, Lyon

69495

Centre Hospitalier Lyon sud, Pierre-Bénite

72000

Clinique Victor Hugo - Centre Jean Bernard, Le Mans

75005

Institut Curie, Paris

75015

Hopital Europeen Georges Pompidou, Paris

75235

Parkland Health and Hospital System, Dallas

75246

Texas Oncology, Sammons Cancer Center, Dallas

75390

UT Southwestern Medical Center at Dallas, Dallas

80045

Research Pharmacist, Aurora

University of Colorado Denver, Anschutz Cancer Pavilion, Aurora

85054

Mayo Clinic Hospital, Phoenix

85258

Premiere Oncology of Arizona, Scottsdale

85259

Mayo Clinic Arizona, Scottsdale

85925

Centre hospitalier departemental Vendee, La Roche-sur-Yon

86021

CHU La Miletrie, Poitiers

87109

New Mexico Oncology Hematology Consultants, Ltd., Albuquerque

89128

Comprehensive Cancer Centers of Nevada, Las Vegas

89135

Nevada Cancer Institute, an affiliate of the UC San Diego Health System, Las Vegas

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90033

LAC & USC Medical Center, Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles

90095

UCLA, Los Angeles

90211

USC Westside Prostate Cancer Center, Beverly Hills

90292

c/o Prostate Oncology Specialist, Inc., Marina del Rey

91010

City of Hope, Duarte

91030

City of Hope Medical Group, South Pasadena

91942

Cancer Center Oncology Medical Group, La Mesa

92056

North County Oncology Medical Clinic, Inc,, Oceanside

92123

Medical Oncology Associates - SD, San Diego

Sharp Memorial Hospital Investigational Pharmacy, San Diego

Sharp Rees-Stealy, San Diego

92151

Hopital Foch, Suresnes

94010

CHU Henri Mondor, Créteil

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

94305

Stanford Hospital and Clinics Research Pharmacy, Stanford

Stanford University Medical Center, Stanford

94805

Institut Gustave Roussy, Villejuif

97239

Portland VA Medical Center, Portland

98109

Seattle Cancer Care Alliance, Seattle

98195

University of Washington Medical Center, Seattle

90211-1850

Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group, Beverly Hills

90095-6984

Ronald Reagan UCLA Medical Center, Los Angeles

06510

C/O: Thomas Ferencz R.Ph., BCOP, New Haven

06520

Yale University School of Med, New Haven

02114

Massachusetts General Hospital (MGH), Boston

02115

Brigham & Women's Hospital (BWH), Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

63110-1094

Barnes-Jewish Hospital, St Louis

37232-5536

Vanderbilt University Medical Center, Nashville

23116-1844

Virginia Cancer Institute, Mechanicsville

23235-4730

Virginia Cancer Institute, Richmond

C1425AWC

Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research), Buenos Aires

X5000JJS

Instituto Oulton, Córdoba

X5004FHP

Clinica Universitaria Privada Reina Fabiola, Córdoba

R8324EMD

Instituto de Investigaciones Clinicas Cipolletti, Cipolletti

S2000DTO

Sanatorio Mapaci, Rosario

S2000KZE

Instituto de Oncologia y Especialidades Medicas, Rosario

S2001ODA

Hospital Italiano Garibaldi, Rosario

C1043AAS

Centro de Diagnostico Dr. Enrique Rossi, Buenos Aires

C1425BEE

Centro de Diagnostico Dr. Enrique Rossi, Buenos Aires

T2N 4N2

Tom Baker Cancer Centre, Calgary

T2S 3C3

Tom Baker Cancer Centre - Holy Cross Site, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V1Y 5L3

British Columbia Cancer Agency, Centre for the Southern Interior, Kelowna

V5Z 4E6

B.C. Cancer Agency - Vancouver Centre, Vancouver

V8R 6V5

British Columbia Cancer Agency - Vancouver Island Centre, Victoria

B3H 1V7

QEII Health Sciences Centre, Halifax

B3H 2Y9

QEII Health Sciences Centre, Halifax

B3H 3A7

QEII Health Sciences Centre, Halifax

L8V 5C2

Juravinski Cancer Centre, Hamilton

N6A 4L6

London Regional Cancer Program, London

M5G 2M9

Princess Margaret Hospital, Toronto

H2L4M1

Centre Hospitalier de l'Universite de Montreal, Montreal

H2X 1N8

The Urology Specialists., Montreal

G1H 6P3

Imagerie medicale de la Capitale, Québec

G1R 2J6

CHU de Quebec, Québec

G1R 3S3

Centre de rechereche clinique et evaluative en oncologie, Québec

Unknown

Hospital San Jose, Santiago

Instituto Nacional del Cancer, Santiago

Centro Investigacion Clinica del Sur, Temuco

Instituto Oncologico, Viña del Mar

B.P. 264 - 06401

Centre hospitalier de Cannes, Cannes

BP110 - 83608

Centre Hospitalier Intercommunal Frejus-Saint Raphael, Fréjus

BP 156 - 13273

Institut Paoli Calmettes, Marseille

D- 10439

Gemeinschaftspraxis Fuer Nuklearmedizin, Berlin

D- 13055

Radiologische Gemeinschaftspraxis, Berlin

D-13055

FacharztzentrumInnere Medizin, Berlin

Praxis Dr. Wolfgang Hoelzer, Berlin

01307

Technical University Dresden, Dresden

D-30625

Medizinische Hochschule Hannover - Klinik fuer Urologie und Urologische Onkologie, Hanover

Medizinische Hochschule Hannover, Hanover

D-48149

Universitaetsklinikum Muenster, Klinik fuer Klinische Radiologie, Münster

Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Nuklearmedizin, Münster

Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Urologie, Münster

D-72076

Abt.f.Diagnostische u. Interventionelle Radiologie, Tübingen

Klinik fuer Urologie, Tübingen

Nuklearmedizin, Tübingen

00152

Azienda Ospedaliera San Camillo Forlanini, Rome

1081 HV

VU Medisch Centrum, Amsterdam

6525 GA

UMC St. Radboud, Nijmegen

3075 EA

Erasmus MC, Rotterdam

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

86-300

Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego, Grudziądz

93-509

Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Regionalny Osrodek Onkologiczny, Lodz

93-513

Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Lodz

76-200

Wojewodzki szpital specjalistyczny im. Janusza Korczaka, Słupsk

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08003

Hospital del Mar, Barcelona

08006

Radiodiagnostic Cetir Clinica Pilar, Barcelona

08025

Hospital Santa Creu i Sant Pau, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

HA6 2JW

Bishops Wood Hospital, Northwood

HA6 2RN

Mount Vernon Hospital, Northwood

SM2 5PT

The Royal Marsden Hospital, Sutton

BT9 7AB

Belfast City Hospital, Belfast

B15 2TH

Cancer Centre, Birmingham

BS2 8ED

Bristol Haematology & Oncology Centre, Bristol

BS2 8HW

Bristol Royal Infirmary, Bristol

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

G12 0YN

The Beatson West of Scotland Cancer Centre, Glasgow

NW1 2BU

University College Hospital, London

W12 0HS

Hammersmith Hospital, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

NE7 7DN

Northern Centre for Cancer Care, Newcastle upon Tyne

OX3 7LJ

Churchill Hospital, Oxford

OX3 7RP

The Manor Hospital Oxford, Oxford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

collaborator

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

INDUSTRY

lead

Pfizer

INDUSTRY