Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

1,059

Participants

Timeline

Start Date

November 11, 2009

Primary Completion Date

January 13, 2012

Study Completion Date

November 28, 2016

Conditions
Prostate Cancer
Interventions
DRUG

Lenalidomide

25 mg lenalidomide orally once each day on Days 1-14

DRUG

Docetaxel

75 mg/m2 intravenous docetaxel on Day 1

DRUG

Prednisone

5 mg prednisone orally twice daily on each day of the treatment cycle

DRUG

Placebo

Oral placebo once each day on Days 1-14 of the treatment cycle

Trial Locations (210)

699

Dr. H. Malan, Polokwane

1020

Krankenhaus der Barmherzigen Brueder, Vienna

1070

Hopital Erasme, Brussels

1076

Fovarosi Onkirmanyzat Peterfy S.Utcai Korhaz-Rend.Int es Baleseti Kozp., Budapest

1090

Medizinische Universitat Wien, Vienna

1106

Fovarosi Onkormanyzat Bajcsy-Zsilinszky Korhaz es Rendelointezet, Budapest

1180

Edith Cavell Clinic, Brussels

2020

ZNA Middelheim, Antwerp

2065

Royal North Shore Hospital, St Leonards

2100

Rigshospitalet University Hospital, Copenhagen

2298

Newcastle Calvary Mater Hospital, Waratah

2730

Herlev Hospital, Herlev

3000

UZ Leuven, Leuven

3050

Royal Melbourne Hospital, Parkville

3526

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Miskolc

3690

Border Medical Oncology, Wodonga

4091

The Oncology Centre Durban, Durban, KZ-Natal

Westridge Medical Centre, Durban, KZ-Natal

4277

Vituro GmbH & Co KG, Leipzig

5000

Odense Universitetshospital, Odense C

5011

The Queen Elizabeth Hospital, Woodville South

5020

Landeskrankenhaus Salzburg, Salzburg

5042

Flinders Medical Centre, Bedford Park

6009

Sir Charles Gairdner Hospital, Nedlands

7460

Netcare Oncology and Interventional Centre, Goodwood, W Cape

7623

Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar, Pécs

7925

Groote Schuur Hospital, Cape Town, W Cape

8000

Arhus Universitets hospital, Aarhus C

8036

Medical University of Graz, Graz

8500

AZ Groeninge, Kortrijk

9100

AZ Nikolaas, Sint-Niklaas

10023

Ordine Mauriziano, Candiolo

10032

Columbia Univ Medical Center, New York

10065

Weill Cornell Medical College Dr. Feldman's Office, New York

10967

Vivantes Klinikum am Urban, Berlin

11528

Alexandra General Hospital of Athens, Athens

12208

New York Oncology Hematology P.C., Albany

14564

Agioi Anargyroi Hospital, Athens

20010

Washington Cancer Institute, Washington D.C.

20246

Universitatsklinikum Hamburg-Eppendorf / IVDP, Hamburg

21044

Maryland Oncology Hematology PA, Columbia

21079

Centre Georges Francois Leclerc, Dijon

22031

Fairfax Northern Virginia Hematology Oncology, Fairfax

22081

IORC- Innovation Onkologie Research and Consulting GmbH, Hamburg

23100

Azienda Ospedaliera Istituti Ospitalieri di Cremona, Cremona

23230

Virginia Cancer Institute, Richmond

23502

Virginia Oncology Associates, Norfolk

24014

Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke

24211

Cancer Outreach Associates, Abingdon

25198

Hospital Arnau de Vilanova, Lleida

27607

Cancer Centers of North Carolina, Raleigh

28041

Hospital 12 de Octobre, Madrid

28562

New Bern Cancer Care, New Bern

29010

HCU Virgen de la Victoria, Málaga

29210

South Carolina Oncology Associates, PA, Columbia

29401

Ralph H. Johnson VA Medical Center, Charleston

29650

Cancer Center of the Carolinas, Greer

30035

Ospedale di Mirano, Mirano (VE)

30900

Clinique de Valdegour, Nîmes

31008

Clinica Universitaria de Navarra, Pamplona

31096

Rambam Health Care Campus, Haifa

32806

Cancer Centers of Florida, P.A.- West Gore Street, Orlando

32901

Melbourne Internal Medicine Associates, Melbourne

33076

Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest, Bordeaux

33176

Advanced Medical Specialties, Miami

33321

South Florida Oncology - Hematology, Tamarac

33401

Palm Beach Cancer Institute, LLC, West Palm Beach

34000

Consultorio de Especialidad en Urologia Privado, Durango, DGO

34474

Ocala Oncology Center, Ocala

34655

Florida Cancer Institute - New Hope, New Port Richey

35042

Centre Eugene Marquis, Rennes

37044

CHRU Hopital Bretonneau, Tours

37404

Chattanooga Oncology Hematology Associates, Chattanooga

38501

Cookeville Regional Medical Center, Cookeville

40113

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La, Ústí nad Labem

40225

Universitaetsklinikum Duesseldorf, Düsseldorf

41110

University Hospital of Larissa, Larissa

42270

Institut de Cancerologie de la Loire, Saint Priest En Jaroz

44805

CRLCC Centre Rene Gauducheau, Saint-Herblain

45040

Consultorio Privado- Dr Jose Arturo Rodriguez Rivera, Zapopan, JAL

45242

Oncology Hematology Care, Inc., Cincinnati

46010

Hospital Clinico Universitario de Valencia, Valencia

46219

Indiana University Health, Indianapolis

47014

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.), Meldola

47900

Ospedale degli Infermi di Rimini, Rimini

48149

Universitaetsklinikum Muenster, Münster

49100

Rabin Medical Center, Petah Tikva

49933

CRLCC Paul Papin, Angers

50009

Hospital Universitario Miguel Servet, Zaragoza

53111

Medizinisches Zentrum Bonn-Friedensplatz, Bonn

55185

Lanssjukhuset Ryhov, Jönköping

55404

Minnesota Oncology Hematology, PA, Minneapolis

56068

Praxis fuer Haematologie und Onkologie Koblenz, Koblenz

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

56429

Papageorgiou General Hospital of Thessaloniki, Thessaloniki

58501

Mid Dakota Clinic, PC, Bismarck

59020

Centre Oscar Lambret, Lille

60068

Lutheran General Hospital, Park Ridge

60488

Krankenhaus Nordwest, Frankfurt a.M.

60714

Cancer Care and Hematology Specialists of Chicagoland, Niles

65201

Missouri Cancer Associates, Columbia

67091

Hopital Civil de Strasbourg, Strasbourg

69373

Centre Leon Berard, Lyon

70006

Hematology and Oncology Specialist, LLC, Metairie

70124

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari, Bari

Azienda Ospedaliero-Universitaria Santa Maria della Miserico, Udine

70300

Assaf Harofeh Medical Center, Ẕerifin

72000

Clinique Victor Hugo, Le Mans

72076

University-Hospital Tübingen, Tübingen

73100

Ospedale Vito Fazzi, Lecce

75246

Baylor Sammons Cancer Center, Dallas

75460

Texas Oncology, P.A. - Paris, Paris

75601

Longview Cancer Center, Longview

75702

Texas Oncology, P.A. - Tyler, Tyler

76014

Texas Oncology-Arlington South, Arlington

76092

Southlake Oncology, Southlake

76104

Texas Oncology, P.A.-Fort Worth, Fort Worth

76310

Texas Oncology-Texoma Cancer Center, Wichita Falls

77598

Texas Oncology Deke Slayton Cancer Center, Webster

78758

Texas Oncology, PA, Austin

79106

Texas Oncology, P.A.-Amarillo, Amarillo

Onkologische Praxis Freiburg, Freiburg im Breisgau

79701

Allison Cancer Center, Midland

80909

Rocky Mountain Cancer Centers-Colorado Springs Circle, Colorado Springs

81200

Hospital Fatima, Sinaloa, SIN

81675

TU München - Klinikum rechts der Isar, München

84101

The Soroka University Medical Center, Beersheba

85012

Hematology Oncology Associates, Phoenix

85710

Arizona Oncology, Tucson

86021

CHU de Poitiers, Poitiers

86336

Northern AZ Hematology and Oncology Assoc, Sedona

89075

Universitatsklinikum Ulm, Ulm

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90025

The Angeles Clinc and Research Institute, Los Angeles

90033

University of Southern California, Los Angeles

90185

Norrlands Universitetssjukhus, Umeå

90292

Prostate Oncology Specialists, Marina del Rey

90822

VA Long Beach Healthcare System, Long Beach

92025

Southwest Cancer Center - Escondido, Escondido

92037

Scripps Cancer Center - Clinical Research, La Jolla

94805

Institut Gustave Roussy, Villejuif

97062

Northwest Cancer Specialists-Tualatin, Tualatin

99218

Evergreen Hematology and Oncology, Spokane

99336

Columbia Basin Hematology and Oncology, Kennewick

105005

Moscow Oncology Clinical Dispensary 1, Moscow

150054

Yaroslavl Regional Clinical Oncology Hospital, Yaroslavl

197758

Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg, Pesochny Vlg Saint Petersburg

249036

Medical Radiology Research Centre RAMS, Obninsk

344011

NSHI Dorozhnaya Clinical Hospital of OAO Russian Railways, Rostov-on-Don

354057

Oncology Dispensary 2 of Krasnodar Region, Sochi

644013

State Institution of Heath Omsk Regional Oncology Dispensary, Omsk

91010-3000

City of Hope Cancer Center, Duarte

94035-5821

Stanford University Medical Center, Stanford

07922

Summit Medical Group Overlook Oncology Center, Berkeley Heights

07960

Hematology-Oncology Associates of NNJ, P, Morristown

08060

Hematology Oncology Associates of South Jersey, Mount Holly

37203-1632

Sarah Cannon Research Institute UK, Nashville

05009

Veterans Education and Research Association of Northern New England, Inc., White River Junction

98108-1532

VA Puget Sound HCS Seattle Division, Seattle

SA 5000

Royal Adelaide Hospital, Adelaide

NSW 2050

Chris O'Brien Lifehouse, Camperdown

NSW 2444

Port Macquarie Base Hospital, Port Macquarie

QLD 4020

Redcliffe Hospital, Redcliffe

NSW 2145

Westmead Hospital, Westmead

QLD 4102

Princess Alexandra Hospital, Woolloongabba

M1P 2T7

The Health Institute for Men CMX Research Inc, Toronto

H2X 1N8

Les Urologues Specialises, Montreal

430 12

Krajska zdravotni, a.s. Nemocnice Chomutov, o.z., Chomutov

150 06

Fakultni nemocnice Motol, Prague

06846

Diakonissenkrankenhaus Dessau gGmbH, Dessau

00149

Azienda Ospedaliera San Camillo Forlanini, Roma

07760

Hospital Angeles Lindavista, D.F, DF

1081 HV

VU University Medical Center VU Medisch Centrum, Amsterdam

6800 TA

Ziekenhuis Rijnstate, Arhem

4818 CK

Amphia Ziekenhuis Molengracht, Breda

1782 GZ

Gemini Ziekenhuis, Den Helder

3317 NM

Albert Schweitzer Ziekenhuis Amstelwijck, Dordrecht

5632 EJ

Catharina Ziekenhuis, Eindhoven

8934 AD

Medisch Centrum Leeuwarden, Leeuwarden

2333 ZA

Leids Universitair Medisch Centrum, Leiden

6229 HX

Academisch Ziekenhuis Maastricht, Maastricht

3435 CM

St. Antonius Ziekenhuis Nieuwegein, Nieuwegein

3015 GD

Erasmus Medical Center, Rotterdam

Erasmus Medisch Centrum, Rotterdam

2545 CH

HagaZiekenhuis, The Hague

5042 AD

Twee Steden Ziekenhuis Tilburg, Tilburg

5912 BL

VieCuri Medisch Centrum Venlo, Venlo

8025 AB

Isala Klinieken, Zwolle

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

93-509

Regionalny Osrodek Onkologiczny WSS im. M. Kopernika, Lodz

10-228

ZOZ MSWiA z Warminsko- Mazurskim Centrum Onkologii, Olsztyn

10-513

NZOZ Olsztynski Osr. Onkologiczny Kopernik Sp.z o.o, Olsztyn

44-200

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Rybnik

02-781

Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie, Warsaw

50-981

4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ, Wroclaw

0083

Pretoria Urology Hospital, Pretoria

08003

Hospital del Mar, Barcelona

08907

Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO, Hospitalet de Llobregat, Barcelona

08221

Hospital Mutua de Terrassa, Terrassa (Barcelona)

721 89

Centrallasarettet Vasteras, Västerås

CH63 4JY

Clatterbridge Centre for Oncology NHS Trust, Bebington, Wirral

CB2 0QQ

Addenbrookes Hospital, Cambridge

GU2 7XX

Royal Surrey County Hospital, Guildford

SE1 9RT

Guy's and St Thomas' Hospital - London, London

SW17 0QT

St George's Hospital, London

SW3 6JJ

Royal Marsden Hospital, London

M20 4BX

Christie NHS Trust Hospital, Manchester

NG5 1PB

Nottingham City Hospital, Nottingham

DN15 7BH

Northern Lincolnshire and Goole Hospitals NHS Foundation Trust, Scunthorpe

SM2 5PT

Royal Marsden Hospital, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY