A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

1,297

Participants

Timeline

Start Date

November 28, 2011

Primary Completion Date

September 25, 2017

Study Completion Date

December 15, 2017

Conditions
Prostate Cancer Metastatic
Interventions
BIOLOGICAL

PROSTVAC-V

BIOLOGICAL

PROSTVAC-F

DRUG

GM-CSF

OTHER

GM-CSF Placebo

BIOLOGICAL

Placebo

PROSTVAC V/F Placebo

Trial Locations (220)

1000

Institut Jules Bordet, Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

2020

Ziekenhuisnetwerk Antwerpen - AZ Middelheim, Antwerp

2065

Sydney Haematology and Oncology Clinic, St Leonards

2200

Rigshospitalet, Copenhagen

2298

Calvary Mater Newcastle, Waratah

2730

Herlev Hospital, Herlev

3000

UZ Leuven, Leuven

3084

Austin Hospital, Heidelberg

3165

Monash Medical Centre - Moorabbin Campus, Bentleigh East

3220

Barwon Health, Geelong

3690

Border Medical Oncology, Wodonga

4020

Redcliffe Hospital, Redcliffe

4102

Princess Alexandra Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

6008

St John of God Hospital, Subiaco

7500

Holstebro Sygehus, Holstebro

8800

H.-Hartziekenhuis Roeselare-Menen vzw, Roeselare

9000

AZ Maria Middelares, Ghent

9100

Aalborg Sygehus, Aalborg

10016

University Urology Associates, New York

11215

Brooklyn Urology Research Group, Brooklyn

12601

Hudson Valley Urology, P.C., Poughkeepsie

14004

Hospital Universitario Reina Sofia, Córdoba

15232

UPMC Cancer Pavillion, Pittsburgh

15706

Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela

16801

Mount Nittany Medical Center, State College

17604

Urological Associates Of Lancaster, Lancaster

19004

Urologic Consultants of Southeaster PA LLP, Bala-Cynwyd

19111

Fox Chase Cancer Center, Philadelphia

20010

Washington Cancer Institute, Washington D.C.

20246

Martini-Klinik am UKE GmbH, Hamburg

20770

Myron Murdock M.D. LLC, Greenbelt

20889

Walter Reed Army Medical Center, Bethesda

20892

National Cancer Institute - Center for Cancer Research, Bethesda

21201

Maryland Prostate Center, Baltimore

21204

Greater Baltimore Medical Center, Baltimore

21218

Union Memorial Hospital, Baltimore

22000

Clinique Armoricaine de Radiologie, Saint-Brieuc

23502

Virginia Oncology Associates PC, Norfolk

26003

The Schiffler Cancer Center, Wheeling

27704

Regional Cancer Care PA, Durham

27705

Durham VA Medical Center, Durham

28007

Hospital General Universitario Gregorio Marañon, Madrid

28025

Northeast Urology Research, Concord

28033

MD Anderson International Espana, Madrid

28041

Hospital 12 de Octubre, Madrid

28050

Centro Integral Oncológico Clara Campal, Madrid

28144

W.G. (Bill) Hefner VA Medical Center, Salisbury

28204

Presbyterian Hospital Center for Cancer Research, Charlotte

28222

Hospital Universitario Puerta de Hierro, Majadahonda

28922

Hospital Universitario Fundación Alcorcón, Madrid

29010

Hospital General Carlos Haya, Málaga

29209

WJB Dorn VA Medical Center, Columbia

29401

Ralph H Johnson VAMC, Charleston

29572

Carolina Urologic Research Center, Myrtle Beach

29605

Greenville Hospital System, Greenville

31008

Clinica Universitaria de Navarra, Pamplona

Clinica Universitaria de Navarra, Pamplona

31048

Bnei Zion Medical Center, Haifa

31096

Rambam Medical Center, Haifa

33180

South Florida Medical Research, Aventura

33401

Palm Beach Cancer Institute, West Palm Beach

33612

James A Haley Veteran Affairs Medical Center, Tampa

33710

Pinellas Urology, Inc., St. Petersburg

33805

Lakeland Regional Cancer Center, Lakeland

33908

Florida Urology Physicians, Fort Myers

34205

Manatee Medical Research Institute, LLC, Bradenton

35043

Klinikum der Philipps-Universität Marburg, Marburg

37044

Hôpital Bretonneau, Tours

37209

Urology Associates, PC, Nashville

37684

James H. Quillen Veterans Affairs Medical Center, Mountain Home

37920

University of TN Medical Center, Knoxville

38120

The West Clinic, P.C., Memphis

41013

Hospital Virgen del Rocio, Seville

43221

Columbus Urology Research, Columbus

44106

University Hospitals Case Medical Center, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44718

Gabrail Cancer Center, Canton

45147

Universitätsklinikum Essen, Essen

45267

University of Cincinnati Medical Center, Cincinnati

46601

Northern Indiana Cancer Research Consortium, South Bend

47130

First Urology PSC, Jeffersonville

49933

Centre Paul Papin, Angers

50009

Hospital Universitario Miguel Servet, Zaragoza

50266

The Iowa Clinic, PC Iowa Urology, West Des Moines

51056

Institut Jean Godinot - Centre de lutte contre le cancer, Reims

52621

The Chaim Sheba Medical Center, Ramat Gan

53127

Universitätsklinikum Bonn, Bonn

53226

Medical College of Wisconsin, Milwaukee

54000

Centre d'Oncologie de Gentilly, Nancy

54511

Centre Alexis Vautrin - Centre Régional de lutte contre le cancer de Lorraine, Vandœuvre-lès-Nancy

55131

Universitätsmedizin der JGU Mainz, Mainz

55905

Mayo Clinic, Rochester

58100

Edith Wolfson Medical Center, Holon

58501

St. Alexius Medical Center, Bismarck

60590

Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt am Main, Frankfurt

60612

Jesse Brown VA, Chicago

64128

Kansas City VA Medical Center, Kansas City

68130

GU Research Network, LLC, Omaha

Nebraska Cancer Specialists, Omaha

69373

Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70112

Tulane University, New Orleans

70121

Ochsner Cancer Institute, New Orleans

70300

Assaf Harofe Medical Center, Tzrifin

72076

Universitätsklinikum Tübingen, Tübingen

72766

Studienpraxis Urologie, Reutlingen

75005

HIA du Val de Grâce, Paris

Institut Curie, Paris

75014

Fondation Hôpital Saint-Joseph, Paris

Institut Mutualiste Montsouris, Paris

75225

Urology Clinics of North Texas, Dallas

75230

Mary Crowley Cancer Research Center, Dallas

76504

Central Texas Veterans Health Care System, Temple

76508

Scott and White Memorial Hospital, Temple

79106

Chirurgische Universitätsklinik Freiburg, Freiburg im Breisgau

80045

University of Colorado, Aurora

80211

The Urology Center of Colorado, Denver

81737

Stadtisches Klinikum Muchen GmbH, Munich

83814

North Idaho Urology, Coeur d'Alene

84101

Soroka University Medical Center, Beersheba

84107

Salt Lake Research, Salt Lake City

84132

University of Utah, Salt Lake City

85258

Scottsdale Healthcare, Scottsdale

85925

Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries, La Roche-sur-Yon

89075

Universitatsklinikum Ulm, Ulm

Universitätsklinikum Ulm, Ulm

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

89502

VA Sierra Nevada HealthCare System, Reno

90048

Cedars-Sinai Medical Center, Los Angeles

90292

Prostate Oncology Specialists, Inc., Marina del Rey

91120

Hadassah University Hospital Ein Kerem, Jerusalem

92120

San Diego Clinical Trials, San Diego

92123

Sharp Memorial Hospital, San Diego

92161

VA San Diego Healthcare System, San Diego

92270

Desert Hematology-Oncology, Rancho Mirage

92404

San Bernardino Urological Associates, San Bernardino

94305

Stanford Advanced Medical Center, Stanford

94704

Alta Bates Summit Medical Center, Berkeley

97080

Universitätsklinikum Würzburg, Würzburg

97477

Willamette Valley Cancer Center, Springfield

98101

Virginia Mason Medical Center, Seattle

98431

Madigan Army Medical Center, Tacoma

99508

Alaska Clinical Research Center, Llc, Anchorage

125248

Moscow Research Oncology Institute n.a. P.A.Gertsen, Moscow

150040

Regional Clinical Oncology Hospital, Yaroslavl

163045

Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk

191015

St. Petersburg Medical Academy of Postgraduate Education, Saint Petersburg

197022

St. Petersburg State Medical University n.a. I.P. Pavlov, Saint Petersburg

197136

"Clinic Andros LLC", Saint Petersburg

198205

City Hospital #15, Saint Petersburg

199178

"Orkli LLC", Saint Petersburg

302020

Orel Oncology Center, Oryol

355047

Stavropol Regional Clinical Oncology Dispensary, Stavropol

420111

Kazan State Medical University, Kazan'

454087

Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk

460021

Orenburg Regional Clinical Oncology Center, Orenburg

600020

Regional Clinical Oncology Center, Vladimir

644013

Clinical Oncology Dispensary, Omsk

02215

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Boston

08054

Delaware Valley Urology LLC - Westhampton, Mount Laurel

08903

The Cancer Institute of New Jersey, New Brunswick

05009

White River Junction Veterans Affairs Medical Center, White River Junction

V1Y 2H4

Southern Interior Medical Research Inc., Kelowna

B3H 2Y9

Capital District Health Authority, Halifax

N3S 6T6

Brantford Urology Research, Brantford

N1R3G2

Cambridge Memorial Hospital, Cambridge

L8N 4A6

St. Josephs Healthcare Hamilton Research Ethics Board, Hamilton

K7L3J7

Queen's University at Kingston, Kingston

N6A 5W9

London Health Sciences Centre, London

L6H 3P1

The Female/Male Health Centres, Oakville

M5G 2M9

Princess Margaret Hospital, Toronto

H2L 4M1

Centre Hospitalier de l'Universite de Montreal, Montreal

G1R 2J6

Centre Hospitalier Universitaire de Quebec Hotel Dieu, Québec

DK-8200

Skejby Sygehus, Århus N

DK-2000

Frederiksberg Hospital, Frederiksberg

DK-4700

Storstrømmens Sygehus Næstved, Næstved

EE-10138

East Tallinn Central Hospital, Tallinn

EE-13419

North Estonia Medical Centre Foundation, Tallinn

EE-51014

Tartu University Hospital, Tartu

07743

Klinikum der Friedrich-Schiller-Universität Jena, Jena

IS-101

Landspitali University Hospital, Reykjavik

1066 CX

NKI-AVL, Amsterdam

1081 HV

VUMC, Amsterdam

6229 HX

Academisch Ziekenhuis Maastricht, Maastricht

6525 GA

Radboudumc, Nijmegen

3015CE

Erasmus MC, Rotterdam

05-827

AMEDS CENTRUM Sp. z o.o., Grodzisk Mazowiecki

08-110

Urologica Praktyka Lekarska Adam Marcheluk, Siedlce

02-616

Szpital sw Elzbiety - Mokotowskie Centrum Medyczne Sp. z o. o., Warsaw

04-749

Miedzyleski Szpital Specjalistyczny w Warszawie, Warsaw

50-556

Klinika Urologii i Onkologii Urologicznej, Uniwersytecki Szpital Kliniczny we Wrocławiu, Wroclaw

00716

Ponce School of Medicine, Ponce

00910

Alliance for Research and Knowledge, San Juan

05004

Hospital Nuestra Señora de Sonsoles, Ávila

08003

Hospital del Mar, Barcelona

08035

Hospital Vall D´Hebron, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

03203

Hospital General Universitario de Elche, Elche

08243

Althaia: Xarxa Assistencial de Manresa, Manresa

07010

Hospital Son Espases, Palma de Mallorca

07198

Fundación Hospital Manacor, Palma de Mallorca

08208

Corporació Sanitaria Parc Taulí, Sabadell

08221

Hospital Mutua de Terrassa, Terrassa

BS2 8ED

Bristol Haematology & Oncology Centre, Bristol

B15 2TH

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham

CF14 2TL

Velindre Hospital, Cardiff

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

GU2 7XP

University of Surrey, Guildford

LS9 7TF

Leeds Teaching Hospitals NHS Trust, St James's University Hospital, Leeds

EC1M 6BQ

St Bartholomews Hospital, London

SW3 6JJ

The Royal Marsden, London

W2 1NY

St Mary's Hospital, London

M20 4BX

Christie Hospital, Manchester

CH63 4JY

The Clatterbridge Cancer Centre NHS Foundation Trust, Metropolitan Borough of Wirral

PL6 8DH

Plymouth Hospitals NHS Trust, Derriford Hospital, Plymouth

SO16 6YD

University of Southampton, Southampton

SM2 5PT

Royal Marsden Hospital, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bavarian Nordic

INDUSTRY