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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,717

Participants

Timeline

Start Date

September 16, 2010

Primary Completion Date

September 30, 2013

Study Completion Date

February 14, 2019

Conditions
Prostate Cancer
Interventions
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.

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.

Trial Locations (269)

1090

Medizinische Universitaet Wien, Vienna

1200

Cliniques Universitaires Saint-Luc, Brussels

2000

Frederiksberg Hospital, Frederiksberg

2031

Prince of Wales Hospital, Randwick

2065

Royal North Shore Hospital, Department of Medical Oncology, St Leonards

2076

Sydney Adventist Hospital, Sydney

Australian Clinical Trials Pty Ltd, Wahroonga

SAN Pathology, Wahroonga

SAN Radiology, Wahroonga

2139

Concord Repatriation General Hospital, Concord

2145

Westmead Hospital, Westmead

2170

Liverpool Hospital, Liverpool

2200

Rigshospitalet, Copenhagen

2217

St George Private Hospital, Kogarah

2298

Calvary Mater Newcastle, Waratah

2444

North Coast Cancer Institute, Port Macquarie

2480

Lismore Base Hospital, Lismore Cancer Care and Haematology Unit, Lismore

2730

Herlev Hospital, Herlev

3000

Peter MacCallum Cancer Centre, Melbourne

UZ Leuven - University Hospital Gasthuisberg, Leuven

3002

Peter MacCallum Cancer Centre, East Melbourne

3021

Sunshine Hospital, St Albans

3084

Austin Hospital, Heidelberg

3128

Eastern Health, Box Hill

MIA Box Hill Radiology, Box Hill

Oncology Eastern Clinical Research Unit (ECRU), Box Hill

Pharmacy Department, Box Hill

3144

Cabrini Hospital Malvern, Malvern

Cabrini Radiology, Malvern

MDI Chemer, Malvern

3168

Monash Health Translation Precinct, Clayton

3186

Cabrini Hospital Brighton, Brighton

3220

Barwon Health, Geelong Hospital, Geelong

3500

Jessaziekenhuis, Hasselt

3550

Bendigo Health, Bendigo Hospital, Bendigo

3552

Bendigo Health Medical Imaging, Bendigo

4000

Centre Hospitalier Universitaire de Liege-Urologie, Liège

Roskilde Sygehus, Roskilde

4006

University of Queensland Centre for Clinical Research (UQCCR), Herston

4010

Krankenhaus der Barmherzigen Schwestern Linz, Linz

4029

Nuclear Medicine and Imaging Department, Herston

4032

Icon Cancer Care Chermside, Chermside

4066

Heart Care Partners, Auchenflower

Icon Cancer Care Wesley, Auchenflower

River City Pharmacy, Auchenflower

4101

Icon Cancer Care South Brisbane, South Brisbane

Icon Cancer Foundation, South Brisbane

Mater Private Cardiology, South Brisbane

5020

Ordination Dr. Fink, Salzburg

Salzburger Universitatsklinikum, Salzburg

5037

Adelaide Cancer Centre, Kurralta Park

APHS Pharmacy, Kurralta Park

Ashford Cancer Centre Research, Kurralta Park

Cancer Care SA Pty Ltd, Kurralta Park

8200

Aarhus Universitetshospital, Aarhus N

8500

AZ Groeninge, Campus KL, Kortrijk

9000

AZ Sint-Lucas, Ghent

9100

Aalborg Hospital Nord, Aalborg

10029

The Mount Sinai Medical Center, New York

10043

Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano

10065

Memorial Sloan-Kettering Cancer Center, New York

10408

National Cancer Center, Goyang-si

12200

Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin, Berlin

13620

Seoul National University Bundang Hospital, Seongnam-si

15006

Complejo Hospitalario Universitario A Coruna, A Coruña

15213

UPMC Presbyterian, Pittsburgh

15232

UPMC Hillman Cancer Center, Pittsburgh

19104

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

20246

Martini-Klinik am UKE Gmbh, Hamburg

22399

Urologikum Hamburg, Hamburg

23456

Virginia Oncology Associates, Virginia Beach

23502

Virginia Oncology Associates, Norfolk

23606

Virginia Oncology Associates, Newport News

23666

Virginia Oncology Associates, Hampton

26100

Azienda Socio Sanitaria Territoriale di Cremona, Cremona

27518

Cancer Centers of North Carolina, Cary

27607

Cancer Centers of North Carolina, Raleigh

27710

Duke University Medical Center, Durham

Investigational Chemotherapy Services, Durham

28034

Hospital Universitario Ramon y Cajal, Madrid

28050

Hospital Madrid Norte Sanchinarro, Madrid

28203

Levine Cancer Institute, Charlotte

28204

Levine Cancer Institute - Main, Charlotte

28211

Levine Cancer Institute - Southpark, Charlotte

28262

Levine Cancer Institute - University, Charlotte

28277

Levine Cancer Institute - Ballantyne, Charlotte

29425

Hematology / Oncology MUSC Hollings Cancer Center, Charleston

Medical University of South Carolina - Urology Services, Charleston

MUSC Department of Radiology, Charleston

MUSC Urology Ambulatory Care, Charleston

29464

MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor, Mt. Pleasant

MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor, Mt. Pleasant

30625

Medizinische Hochschule Hannover, Hanover

31008

Clínica Universidad de Navarra, Pamplona

31048

Bnai Zion Medical Center, Haifa

31300

Clinique Pasteur, Toulouse

33486

Lynn Cancer Institute Center for Hematology Oncology, Boca Raton

33520

Tampere University Hospital, Tampere

35042

Centre Eugene Marquis-Service d'Oncologie Medicale, Rennes

35249

University of Alabama at Birmingham, Birmingham

35294

University of Alabama at Birmingham, Birmingham

38126

Staedtisches Klinikum Braunschweig gGmbH, Braunschweig

40245

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

42271

Institut de Cancerologie Lucien Neuwirth, Saint-Priest-en-Jarez

44805

Centre de Recherche Clinique, Saint-Herblain

47014

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

47100

Ospedale G.B. Morgagni, Forlì

48149

Universitaetsklinikum Muenster, Münster

48201

Karmanos Cancer Institute, Detroit

48334

Karmanos Cancer Institute Weisberg Cancer Treatment Center, Farmington Hills

49055

ICO Paul Papin, Angers

49100

Rabin Medical Center, Petah Tikva

52100

Azienda USL8-Presidio Ospedaliero S.Donato, Arezzo

52621

The Chaim Sheba Medical Center, Ramat Gan

53792

University of Wisconsin Hospital and Clinics, Madison

55905

Mayo Clinic, Rochester

60611

Northwestern Medical Faculty Foundation, Chicago

Northwestern Memorial Hospital, Chicago

63108

BJH Pharmacy, St Louis

63110

Barnes-Jewish Hospital, St Louis

Washington University School of Medicine, St Louis

63141

Barnes-Jewish West County Hospital, Creve Coeur

63376

Barnes-Jewish St. Peters Hospital, City of Saint Peters

66424

Universitaetsklinikum des Saarlandes, Homburg/Saar

68114

Nebraska Methodist Hospital, Omaha

68167

Universitaetsklinikum Mannheim, Klinik fuer Urologie, Mannheim

69120

Universitaetsklinikum Heidelberg, Klinik Fuer Urologie, Heidelberg

70300

Assaf Harofe Medical Center, Beer Yaakov

72000

Centre Jean Bernard - Clinique Victor Hugo, Le Mans

72076

Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie, Tübingen

75005

Institut Curie, Paris

75013

Groupe Hospitalier La Pitie Salpetriere, Paris

75390

UT Southwestern Medical Center at Dallas, Dallas

75908

Hopital Europeen Georges Pompidou, Paris

80045

Anschutz Cancer Center Pavilion Pharmacy, Aurora

University of Colorado Hospital, Anschutz Cancer Pavilion, Aurora

84000

Clinique Rhone Durance, Avignon

84101

Soroka University Medical Center, Beersheba

85719

The University of Arizona Cancer Center-North Campus, Tucson

The University of Arizona Cancer Certer-North Campus, Tucson

85925

CHD Vendee, La Roche-sur-Yon

89075

Universitaetsklinikum Ulm, Ulm

90033

Keck Hospital of USC, Los Angeles

LAC&USC Medical Center, Los Angeles

USC/Norris Comprehensive Cancer Center / Investigational Drug Services, Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles

90095

Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services, Los Angeles

UCLA Clark Urology Clinic, Los Angeles

90220

Oulu University Hospital, Oulu

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

92288

Klaipeda University Hospital, Klaipėda

92637

Kliniken Nordoberpfalz AG, Klinikum Weiden, Weiden in Der Oberpfalz

94305

Stanford University Medical Center, Stanford

94805

Institut Gustave Roussy, Villejuif

95817

UC Davis Medical Center, Sacramento

University of California Davis Comprehensive Cancer Center, Sacramento

97239

Portland VA Medical Center Laboratory, Portland

98109

Seattle Cancer Care Alliance, Seattle

98195

University of Washington Medical Center, Seattle

115478

Russian Academy of Medical Sciences Institution, Moscow

119074

Department of Urology, National University Hospital, Singapore

169608

Singapore General Hospital, Singapore

191015

North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare, Saint Petersburg

197022

State Educational Institution of Higher Professional Education, Saint Petersburg

197758

State healthcare institute, Saint Petersburg

619763

Chonnam National University Hwasun Hospital, Hwasun-eup, Hwasun-gun

1058471

Jikei University Hospital, Tokyo

1138603

Nippon Medical School Hospital, Bunkyo-ku

1358550

Cancer Institute Hospital, Koutou-ku

1428666

Showa University Hospital, Shinagawa-ku

1608582

Keio University Hospital, Shinjyuku-ku

1738610

Nihon University Itabashi Hospital, Itabashi-ku

2360004

Yokohama City University Hospital, Yokohama

2608717

Chiba Cancer Center, Chiba

5418567

Osaka International Cancer Institute, Osaka

5450051

Osaka City University Hospital, Osaka

5650871

Osaka University Hospital, Suita-shi

5898511

Kindai University Hospital, Ōsaka-sayama

6068507

Kyoto University Hospital, Kyoto

7558505

Yamaguchi University Hospital, Ube-shi

7708503

Tokushima University Hospital, Tokushima

8128582

Kyushu University Hospital, Fukuoka

8528501

Nagasaki University Hospital, Nagasaki

9518520

Niigata University Medical and Dental Hospital, Niigata

9800872

Tohoku University Hospital, Sendai

9902292

Yamagata Prefectural Central Hospital, Yamagata

02115

Brigham & Women's Hospital, Boston

02215

Beth Israel Deaoness Medical Center, Boston

Dana Farber Cancer Institute, Boston

T2N 4N2

Alberta Health Services - Cancer Care, 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, Sindi Ahluwalia Hawkins, Centre for the Southern Interior, Kelowna

V5Z 1M9

Vancouver Prostate Centre, Vancouver

V8R 1J8

Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging, Victoria

V8R 6V5

British Columbia Cancer Agency - Vancouver Island Centre, Victoria

R3E 0V9

Manitoba Prostate Centre, Winnipeg

B3H 1V7

QEII Health Sciences Centre, Nova Scotia Cancer Centre., Halifax

B3H 2Y9

QEII Health Sciences Centre, Halifax

B3H 3A7

QEII Health Sciences Centre, Halifax

L8V5C2

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton

N6A 4L6

London RegCancer Program, London Health Sciences Centre, London

K1H8L6

The Ottawa Hospital Cancer Centre, General Campus, Ottawa

K2H 8P4

The Ottawa Hospital Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H2L 4M1

Centre Hospitalier de l'Universite de Montreal, Montreal

G1R 2J6

CHU de Quebec - L'Hotel-Dieu de Quebec, Québec

G1R 3S1

Centre de recherche clinique el evaluative en oncologie (CRCEO), Québec

00180

Docrates Clinic, Helsinki

00290

Helsinki University Central Hospital, Helsinki

FR-67901

Hopital Civil, Strasbourg

FR-33076

Institut Bergonie, Bordeaux

Institut Bergonie, Bordeaux

69008 Cedex 08

Centre Leon Berard, Lyon

FR-94160

HIA Begin, Service de Medecine Interne et Oncologie, Saint-Mandé

01307

Universitaetsklinikum Carl Gustav Carus Dresden an der, Dresden

00152

Azienda Ospedaliera San. Camillo Forlanini, Rome

181 8611

Kyorin University Hospital, Mitaka-shi

08660

Division of Oncourology, National Cancer Institute, Vilnius

1081 HV

Vrije Universiteit Medical Center, Department of Medical Oncology, Amsterdam

5623 EJ

Catharina Ziekenhuis, Eindhoven

9713 GZ

University Medical Center Groningen, Department of Urology, Groningen

6525 GA

UMC St. Radboud, Nijmegen

61-866

Wielkopolskie Centrum Onkologii, Poznan

54-144

EMC Instytut Medyczny S.A., Wroclaw

80-214

Apteka Szpitalna, Gdansk

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

41-400

Niepubliczny Zaklad Opieki Zdrowotnej, Mysłowice

93-509

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

975 17

Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica, Banská Bystrica

851 05

CUIMED s.r.o., Bratislava

036 59

Univerzitna Nemocnica Martin, Martin

949 01

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

080 01

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

UROCENTRUM MILAB s.r.o., Prešov

06351

Samsung Medical Center, Gangnam-gu

05505

Asan Medical Center, Songpa-gu

03722

Severance Hospital, Yonsei University Health System, Seoul

06273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

07010

Hospital Son Espases, Palma de Mallorca

08916

Hospital Universitario German Trias i Pujol, Badalona

08243

Althaia Xarxa Asistencial Manresa, Manresa

08003

Hospital del Mar, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clinic i Provincial, Barcelona

08208

Corporacio Sanitaria Parc Tauli, Sabadell(Barcelona)

SE-413 45

Sahlgrenska University Hospital, Gothenburg

SE-205 02

Skane University Hospital, Malmo

se-701 85

Orebro University Hospital, Örebro

SE-171 76

Karolinska University Hospital Solna, Stockholm

SE-901 85

Umea University Hospital, Umeå

HA6 2JW

Bishops Wood Hospital, Northwood

HA6 2RN

Mount Vernon Hospital, Northwood

OX3 7LJ

Oxford University Hospitals NHS Trust, Oxford

SM2 5PT

Royal Marsden Hospital, Sutton

NE7 7DN

Northern Centre for Cancer Care, Newcastle upon Tyne

CF14 2TL

Velindre Cancer Centre, Cardiff

CH63 4JY

Clatterbridge Cancer Centre NHS Foundation Trust, Bebington

BN2 5BE

Clinical Investigations and Research Unit, Royal Sussex County Hospital, Brighton, East Sussex

BS2 8ED

University Hospitals Bristol NHS Foundation Trust, Bristol

EH4 2XU

Edinburgh Cancer Centre, Edinburgh

NW1 2PG

University College London Hospital NHS Trust, London

SE1 9RT

Guy's and St Thomas' NHS Foundation Trust, London

W12 0HS

Imperial College Healthcare NHS Trust, London

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