Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

1,182

Participants

Timeline

Start Date

May 26, 2014

Primary Completion Date

January 28, 2020

Study Completion Date

January 28, 2020

Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
BIOLOGICAL

DCVAC/PCa

DCVAC/PCa concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). DCVAC/PCa was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of DCVAC/PCa was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.

BIOLOGICAL

Placebo

Placebo concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). Placebo was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of placebo was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.

Trial Locations (177)

1020

Krankenhaus Barmherzige Brueder, Vienna

1090

AKH Universitatskrankenhaus Wien, Vienna

1303

Multifunctional Hospital for Active Treatment Serdika, Sofia

1784

Specialized Hospital for Active Treatment of Oncology Diseases, Sofia

4000

Central Oncology Hospital, Plovdiv

Complex Oncology Center, Plovdiv

5020

Universitatsklinikum fur Urologie und Andrologie, Salzburg

6300

Specialized Hospital for Active treatment in Oncology, Haskovo

10000

Clinical Hospital Center Zagreb, Zagreb

University Hospital Center Sisters of Charity, Zagreb

10029

Mount Sinai Medical Center, New York

10467

Montefiore Medical Center, The Bronx

11000

CHC Zemun, Belgrade

Clinical Center of Serbia, Belgrade

Institute of Oncology and Radiology of Serbia, Belgrade

11080

KBC Bezanijska Kosa, Belgrade

12100

A.O. Santa Croce e Carle Oespedale, Cuneo

12200

Charite Universitatsklinikum Berlin, Berlin

13210

SUNY Upstate Medical University, Syracuse

15232

UPMC Cancer Center, Pittsburgh

18045

Cancer Care Associates St. Luke's University and Health Network, Easton

19004

Urologic Consultants of Southeastern Pennsylvania, Bala-Cynwyd

19111

Fox Chase Cancer Center, Philadelphia

20007

Medstar Georgetown University Hospital, Washington D.C.

20850

Associates In Oncology/Hematology,P.C, Rockville

21201

University of Maryland Greenebaum Cancer Center, Baltimore

22060

Fort Belvoir Community Hospital, Fort Belvoir

22763

Asklepios-Klinik Hamburg-Altona, Hamburg

23502

Virginia Oncology Associates, Norfolk

26100

A.O. Istituti Ospitalieri di Cremona, Cremona

26133

Klinikum Oldenburg AOR, Oldenburg

26389

Praxigemeinschaft fur Onkologie und Urologie, Wilhelmshaven

26506

West Virginia University Mary Babb Randolph Cancer Center, Morgantown

26655

Ammerland Klinik fur Urologie, Westerstede

28007

Hospital General Universitario Gregorio Maranón, Madrid

28040

Hosp. Clinico Univ. San Carlos, Madrid

Instituto de Investigaciones Sanitarias (IIS), Fundacíon Jimenez Díaz (FJD), Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28050

Centro Integral Oncológico Clara Campal (CIOCC), Madrid

28222

Hospital Universitario Puerta de Hierro de Majadahonda, Madrid

28223

Hospital Universitario Quiron Madrid, Pozuelo de Alarcón

28805

Hospital Universitario Príncipe de Asturias, Alcalá de Henares

29010

Hospital Carlos Haya, Málaga

29572

Carolina Urologic Research Center, Myrtle Beach

30322

Winship Cancer Institute of Emory University, Atlanta

30625

Medizinische hochschule Hannover, Hanover

33136

Univ. of Miami, Sylvester Comprehensive Cancer Center, Miami

36604

University of South Alabama Mitchell Cancer Institute, Mobile

37421

Associates in Oncology & Hematology, Chattanooga

38126

Stadtisches Klinikum Braunschweig, Braunschweig

42000

General Hospital Varazdin, Varaždin

45267

UC Health University of Cincinnati, Cincinnati

46003

Urologicke oddeleni, Krajska nemocnice, Liberec

48202

Henry Ford Health System, Detroit

Karmanos Cancer Center, Detroit

50009

Lithuanian University of Health Science Oncology Institute, Kaunas

50937

Klinik und Poliklinik Urologie, Cologne

53100

Azienda Ospedialiera Universitaria Senese, Siena

55404

Minnesota Oncology Hematology, P.A., Minneapolis

64111

Saint Luke's Cancer Institute, Kansas City

66205

University of Kansas Cancer Center & Medical Pavilion, Westwood

67091

Hospital Civil de Strasbourg, Strasbourg

68130

GU Research Network, Omaha

Nebraska Cancer Specialists, Omaha

68167

Universitatsmedizin Mannheim, Mannheim

70112

Tulane University, New Orleans

72076

Universitastsklinikum Tubingen, Tübingen

72622

Studienpraxis Urologie, Nürtingen

75014

Hospital Cochin, Service de Urologie, Paris

75093

Texas Health Physicians Group, Plano

75701

Tyler Hematology Oncology, Tyler

75908

HEGP medical oncology, Paris

76012

Arlington Cancer Center, Arlington

77030

UT Health, Internal Medicine, Division of Oncology, Houston

78217

Cancer Care Network of South Texas, San Antonio

80012

Rocky Mountain Cancer Centers, Aurora

80045

University of Colorado, Aurora

84106

Utah Cancer Specialists, Salt Lake City

85224

Ironwood Cancer & Research Centers, Chandler

89052

Comprehensive Cancer Research Centers of Nevada, Henderson

89075

Universitatsklinikum Ulm, Ulm

90033

Hao Wei Zhang, MD, LLC, Los Angeles

90603

Oncology Institute of Hope and Innovation, Whittier

91054

Waldkrankenhaus St. Marien, Erlangen

92024

California Cancer Associates for Research and Excellence, Encinitas

92123

Sharp Clinical Oncology Research, San Diego

92270

Desert Hematology Oncology Medical Group, Rancho Mirage

92288

Klaipeda University Hospital, Klaipėda

92501

Compassionate Care Research Group, Inc., Riverside

92708

Compassionate Care Research Group, Inc., Fountain Valley

92835

St. Joseph Heritage Healthcare, Fullerton

92879

Compassionate Care Research Group, Inc., Corona

94160

HIA Begin, Saint-Mandé

95123

A.O.U. Policlinico Vittorio Emanuele, Catania

97062

Northwest Cancer Specialists, P.C., Tualatin

97239

Oregon Health & Science University, Portland

98012

Virginia Mason Medical Center, Seattle

98039

Oncologia medica Ospedale S. Vincenzo, Taormina

98405

Northwest Medical Specialties, PLLC, Tacoma

220013

Minsk City Oncological Hospital, Minsk

223040

N.N. Alexandrov National Research Center, Lesnoy

85259-5499

Mayo Clinic, Scottsdale

06519

Yale Cancer Center, New Haven

06360

Eastern CT Hematology and Oncololgy Associates, Norwich

02115

Dana-Farber Cancer Institute, Boston

01655

Umass Memorial Medical Center, Worcester

08724

New Jersey Hematology Oncology Associates, Brick

08648

Premier Urology Associates, LLC / AdvanceMed Research, Lawrenceville

08901

Cancer Institute of New Jersey, New Brunswick

01000

Clinique d'Oncologie Medicale Institut Jules Bordet, Brussels

01070

Erasme Hospital- Urologie, Brussels

01200

Cliniques Universitaires Saint Luc- Urologie, Brussels

09000

Urologie UZ Gent, Ghent

02300

Urology Department St. Elizabeth Ziekenhuis, Turnhout

430 12

Onkologicke centrum, Nemocnice Chomutov, Chomutov

500 05

Klinika onkologie a radioterapie, Fakultni nemocnice, Hradec Králové

586 33

Nemocnice Jihlava, urologicke oddeleni, Jihlava

775 20

Onkologicka klinika, Fakultni nemocnice, Olomouc

708 52

Klinika onkologicka, Fakultni nemocnice, Ostrava-Poruba

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

12 808

Vseobecna fakultni nemocnice v Praze, Prague

140 00

Thomayerova nemocnice, Prague

150 06

Fakultni nemocnice v Motole, Prague

401 13

Krajska zdravotni, urologicke oddeleni, Ústí nad Labem

02100

Rigshospitalet, Copenhagen

75 010

St-Louis IDF Medical Oncology, Paris

75 014

Hopital St. Joseph, Paris

01307

Universtatsklinikum Carl Gustav Carus, Dresden

60 439

Krankenhaus Nordwest, Frankfurt

06120

Universitatsklinikum Halle (Saale), Halle

30 559

Vinzenkrankenhaus Hannover, Hanover

07743

Universitatskinikum Jena, Jena

48 149

Universtatsklinikum Munster, Münster

H-1062

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

H-1097

Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeszet, Budapest

H-1106

Bajcsy-Zsilinsky Korhaz, Budapest

H-5004

Jasz-Nagykun-Szolnok Megyei, Szolnok

Unknown

CRO Aviano, Aviano

00161

Universita di Roma Sapienza, Rome

LV-1079

Paula Stradina Kliniska Universitates slimnica, Riga

08 661

Vilnius University Hospital, Vilnius

08660

National Cancer Institute, Vilnius

1007 MB

VU medical Center, Amsterdam

9401 RK

Wilhemina Ziekenhuis, Assen

1213 XZ

Tergooi Ziekenhuizen, Hilversum

2134 TM

Spaarne Gasthuis, Hoofddorp

08934

Oncology Medisch Centrum, Leeuwarden

06525

UMC St.Radboud, Nijmegen

03079

Oncology Maasstad Ziekenhuis, Rotterdam

62-500

Przychodnia Lekarska (KOMED), Konin

93-513

Szpital im M.Kopernika, Lodz

02-781

INSTYTUT im. Marii Sklodowskiej-Curie, Warsaw

04-125

Centrum Medyczne Ostrobramska, Warsaw

50-556

Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Wroclaw

1500-650

Hospital da Luz, Lisbon

1645-039

Centro Hospitalar de Lisboa Norte, E.P.E - Hospital de Santa Maria, Lisbon

4200-319

Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E, Porto

851 01

J.Breza MEDICAL s.r.o., Bratislava

851 05

Urologicka ambulancia CUIMED s.r.o., Bratislava

036 59

Univerzitna nemocnica Martin, Martin

949 01

Urologicka ambulancia Uroexam, spol. s r.o., Nitra

921 01

UROX s.r.o., Piešťany

080 01

Urocentrum MILAB s.r.o., Prešov

911 01

Privatna urologicka ambulancia, Trenčín

012 07

Fakultna nemocnica s poliklinikou Zilina, Žilina

08035

Hospital Clinic I Provincial de Barcelona, Barcelona

SE-701 85

Örebro University Hospital, Örebrö

901 85

University Hospital Umeå, Dept Oncology, Umeå

CH63 4JY

The Clatterbridge Cancer Centre, Bebington

B15 2TH

University Hospitals Birmingham NHS Foundation Trust, Birmingham

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

GU2 7XX

St. Luke's Cancer Centre Royal Surrey County Hospital NHS Foundation Trust, Guildford

NW3 2QG

Royal Free Hospital, London

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

NE7 7DN

Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne

All Listed Sponsors
lead

SOTIO a.s.

INDUSTRY

NCT02111577 - Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer | Biotech Hunter | Biotech Hunter