Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Biological: PlaceboBiological: DCVAC/PCa
- Registration Number
- NCT02111577
- Lead Sponsor
- SOTIO a.s.
- Brief Summary
The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.
- Detailed Description
This was a randomized, double blind, placebo-controlled, multicenter, international, parallel-group phase III study. Patients with metastatic castration-resistant prostate cancer who were candidates to receive standard of care first-line chemotherapy with docetaxel plus prednisone were randomized 2:1 into one of two arms: an investigational arm (DCVAC/PCa) and a control arm (placebo) in addition to chemotherapy (docetaxel plus prednisone).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1182
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo with standard of care chemotherapy Placebo Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator DCVAC/PCa with standard of care chemotherapy DCVAC/PCa Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
- Primary Outcome Measures
Name Time Method Overall Survival, Intention-to-treat Population From randomization to death due to any cause, up to 58 months Overall survival is defined as the time from randomization until death due to any cause.
- Secondary Outcome Measures
Name Time Method Time to PSA Progression, Per Protocol Population Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.
Proportion of Patients With Skeletal-related Events, Per Protocol Population From randomization to the end of the study, up to 57 months Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Skeletal-related events included:
* Radiation therapy to bone
* Pathologic bone fracture
* Spinal cord compression
* Surgery to bone
* Change in antineoplastic therapy to treat bone painOverall Survival, Per Protocol Population From randomization to death due to any cause, up to 58 months Overall survival is defined as the time from randomization until death due to any cause.
Overall Survival, Intention-to-treat Population, Abiraterone as Prior Therapy From randomization to death due to any cause, up to 58 months Overall survival is defined as the time from randomization until death due to any cause.
Overall Survival, Intention-to-treat Population, Enzalutamide as Prior Therapy From randomization to death due to any cause, up to 58 months Overall survival is defined as the time from randomization until death due to any cause.
Radiological Progression-free Survival, Intention-to-treat Population Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Time to First Skeletal-related Event, Intention-to-treat Population Time from randomization to the date of the first skeletal-related event, up to 58 months Skeletal-related events included:
* Radiation therapy to bone
* Pathologic bone fracture
* Spinal cord compression
* Surgery to bone
* Change in antineoplastic therapy to treat bone painProportion of Patients With Skeletal-related Events, Intention-to-treat Population From randomization to the end of the study, up to 57 months Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Skeletal-related events included:
* Radiation therapy to bone
* Pathologic bone fracture
* Spinal cord compression
* Surgery to bone
* Change in antineoplastic therapy to treat bone painTime to PSA Progression, Intention-to-treat Population Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.
Time to First Skeletal-related Event, Per Protocol Population Time from randomization to the date of the first skeletal-related event, up to 58 months Skeletal-related events included:
* Radiation therapy to bone
* Pathologic bone fracture
* Spinal cord compression
* Surgery to bone
* Change in antineoplastic therapy to treat bone painOverall Survival, Intention-to-treat Population, no Prior Abiraterone or Enzalutamide From randomization to death due to any cause, up to 58 months Overall survival is defined as the time from randomization until death due to any cause.
Radiological Progression-free Survival, Per Protocol Population Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Time to Radiological Progression or Skeletal-related Event, Intention-to-treat Population Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Skeletal-related events included:
* Radiation therapy to bone
* Pathologic bone fracture
* Spinal cord compression
* Surgery to bone
* Change in antineoplastic therapy to treat bone painTime to Radiological Progression or Skeletal-related Event, Per Protocol Population Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Skeletal-related events included:
* Radiation therapy to bone
* Pathologic bone fracture
* Spinal cord compression
* Surgery to bone
* Change in antineoplastic therapy to treat bone pain
Trial Locations
- Locations (175)
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Compassionate Care Research Group, Inc.
🇺🇸Riverside, California, United States
Associates in Oncology & Hematology
🇺🇸Chattanooga, Tennessee, United States
Comprehensive Cancer Research Centers of Nevada
🇺🇸Henderson, Nevada, United States
Hao Wei Zhang, MD, LLC
🇺🇸Los Angeles, California, United States
University of Kansas Cancer Center & Medical Pavilion
🇺🇸Westwood, Kansas, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
St. Joseph Heritage Healthcare
🇺🇸Fullerton, California, United States
University of Maryland Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Arlington Cancer Center
🇺🇸Arlington, Texas, United States
Universitatsklinikum fur Urologie und Andrologie
🇦🇹Salzburg, Austria
N.N. Alexandrov National Research Center
🇧🇾Lesnoy, Belarus
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
AKH Universitatskrankenhaus Wien
🇦🇹Wien, Austria
Krankenhaus Barmherzige Brueder
🇦🇹Wien, Austria
Minsk City Oncological Hospital
🇧🇾Minsk, Belarus
Univerzitna nemocnica Martin
🇸🇰Martin, Slovakia
Tergooi Ziekenhuizen
🇳🇱Hilversum, Netherlands
Paula Stradina Kliniska Universitates slimnica
🇱🇻Riga, Latvia
Spaarne Gasthuis
🇳🇱Hoofddorp, Netherlands
CHC Zemun
🇷🇸Belgrade, Serbia
J.Breza MEDICAL s.r.o.
🇸🇰Bratislava, Slovakia
Urologicka ambulancia Uroexam, spol. s r.o.
🇸🇰Nitra, Slovakia
Urocentrum MILAB s.r.o.
🇸🇰Presov, Slovakia
Fakultna nemocnica s poliklinikou Zilina
🇸🇰Zilina, Slovakia
Univ. of Miami, Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
UT Health, Internal Medicine, Division of Oncology
🇺🇸Houston, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Szpital im M.Kopernika
🇵🇱Lodz, Poland
Saint Luke's Cancer Institute
🇺🇸Kansas City, Kansas, United States
Sharp Clinical Oncology Research
🇺🇸San Diego, California, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
UC Health University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Cancer Care Network of South Texas
🇺🇸San Antonio, Texas, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Rocky Mountain Cancer Centers
🇺🇸Aurora, Colorado, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
GU Research Network
🇺🇸Omaha, Nebraska, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Ironwood Cancer & Research Centers
🇺🇸Chandler, Arizona, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
California Cancer Associates for Research and Excellence
🇺🇸Encinitas, California, United States
Desert Hematology Oncology Medical Group
🇺🇸Rancho Mirage, California, United States
Oncology Institute of Hope and Innovation
🇺🇸Whittier, California, United States
Eastern CT Hematology and Oncololgy Associates
🇺🇸Norwich, Connecticut, United States
Medstar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Associates In Oncology/Hematology,P.C
🇺🇸Rockville, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Umass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
New Jersey Hematology Oncology Associates
🇺🇸Brick, New Jersey, United States
Premier Urology Associates, LLC / AdvanceMed Research
🇺🇸Lawrenceville, New Jersey, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Northwest Cancer Specialists, P.C.
🇺🇸Tualatin, Oregon, United States
Urologic Consultants of Southeastern Pennsylvania
🇺🇸Bala-Cynwyd, Pennsylvania, United States
UPMC Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Cancer Care Associates St. Luke's University and Health Network
🇺🇸Easton, Pennsylvania, United States
Texas Health Physicians Group
🇺🇸Plano, Texas, United States
Tyler Hematology Oncology
🇺🇸Tyler, Texas, United States
Fort Belvoir Community Hospital
🇺🇸Fort Belvoir, Virginia, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Northwest Medical Specialties, PLLC
🇺🇸Tacoma, Washington, United States
West Virginia University Mary Babb Randolph Cancer Center
🇺🇸Morgantown, West Virginia, United States
Specialized Hospital for Active treatment in Oncology
🇧🇬Haskovo, Bulgaria
Erasme Hospital- Urologie
🇧🇪Brussels, Belgium
Clinique d'Oncologie Medicale Institut Jules Bordet
🇧🇪Brussels, Belgium
Urologie UZ Gent
🇧🇪Gent, Belgium
Cliniques Universitaires Saint Luc- Urologie
🇧🇪Brussels, Belgium
Urology Department St. Elizabeth Ziekenhuis
🇧🇪Turnhout, Belgium
Central Oncology Hospital
🇧🇬Plovdiv, Bulgaria
Multifunctional Hospital for Active Treatment Serdika
🇧🇬Sofia, Bulgaria
Complex Oncology Center
🇧🇬Plovdiv, Bulgaria
Specialized Hospital for Active Treatment of Oncology Diseases
🇧🇬Sofia, Bulgaria
General Hospital Varazdin
🇭🇷Varaždin, Croatia
Clinical Hospital Center Zagreb
🇭🇷Zagreb, Croatia
University Hospital Center Sisters of Charity
🇭🇷Zagreb, Croatia
Onkologicke centrum, Nemocnice Chomutov
🇨🇿Chomutov, Czechia
Klinika onkologie a radioterapie, Fakultni nemocnice
🇨🇿Hradec Kralove, Czechia
Thomayerova nemocnice
🇨🇿Prague, Czechia
Klinika onkologicka, Fakultni nemocnice
🇨🇿Ostrava-Poruba, Czechia
Nemocnice Jihlava, urologicke oddeleni
🇨🇿Jihlava, Czechia
Onkologicka klinika, Fakultni nemocnice
🇨🇿Olomouc, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Prague, Czechia
Urologicke oddeleni, Krajska nemocnice
🇨🇿Liberec, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Prague, Czechia
Krajska zdravotni, urologicke oddeleni
🇨🇿Usti nad Labem, Czechia
Fakultni nemocnice v Motole
🇨🇿Prague, Czechia
Rigshospitalet
🇩🇰Copenhagen, Denmark
HEGP medical oncology
🇫🇷Paris Cedex 15, France
St-Louis IDF Medical Oncology
🇫🇷Paris, France
Hopital St. Joseph
🇫🇷Paris, France
Hospital Cochin, Service de Urologie
🇫🇷Paris, France
HIA Begin
🇫🇷Saint Mandé, France
Hospital Civil de Strasbourg
🇫🇷Strasbourg, France
Stadtisches Klinikum Braunschweig
🇩🇪Braunschweig, Germany
Charite Universitatsklinikum Berlin
🇩🇪Berlin, Germany
Universtatsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Waldkrankenhaus St. Marien
🇩🇪Erlangen, Germany
Krankenhaus Nordwest
🇩🇪Frankfurt, Germany
Universitatsklinikum Halle (Saale)
🇩🇪Halle, Germany
Vinzenkrankenhaus Hannover
🇩🇪Hannover, Germany
Asklepios-Klinik Hamburg-Altona
🇩🇪Hamburg, Germany
Medizinische hochschule Hannover
🇩🇪Hannover, Germany
Universitastsklinikum Tubingen
🇩🇪Tübingen, Germany
Klinik und Poliklinik Urologie
🇩🇪Köln, Germany
Universtatsklinikum Munster
🇩🇪Münster, Germany
Universitatskinikum Jena
🇩🇪Jena, Germany
Universitatsmedizin Mannheim
🇩🇪Mannheim, Germany
Magyar Honvedseg Egeszsegugyi Kozpont
🇭🇺Budapest, Hungary
Studienpraxis Urologie
🇩🇪Nürtingen, Germany
Klinikum Oldenburg AOR
🇩🇪Oldenburg, Germany
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeszet
🇭🇺Budapest, Hungary
Jasz-Nagykun-Szolnok Megyei
🇭🇺Szolnok, Hungary
Ammerland Klinik fur Urologie
🇩🇪Westerstede, Germany
Universitatsklinikum Ulm
🇩🇪Ulm, Germany
CRO Aviano
🇮🇹Aviano, Italy
A.O. Istituti Ospitalieri di Cremona
🇮🇹Cremona, Italy
Praxigemeinschaft fur Onkologie und Urologie
🇩🇪Wilhelmshaven, Germany
Bajcsy-Zsilinsky Korhaz
🇭🇺Budapest, Hungary
A.O.U. Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
A.O. Santa Croce e Carle Oespedale
🇮🇹Cuneo, Italy
Universita di Roma Sapienza
🇮🇹Rome, Italy
Lithuanian University of Health Science Oncology Institute
🇱🇹Kaunas, Lithuania
Azienda Ospedialiera Universitaria Senese
🇮🇹Sienna, Italy
Oncologia medica Ospedale S. Vincenzo
🇮🇹Taormina, Italy
Klaipeda University Hospital
🇱🇹Klaipeda, Lithuania
Wilhemina Ziekenhuis
🇳🇱Assen, Netherlands
VU medical Center
🇳🇱Amsterdam, Netherlands
National Cancer Institute
🇱🇹Vilnius, Lithuania
Vilnius University Hospital
🇱🇹Vilnius, Lithuania
Przychodnia Lekarska (KOMED)
🇵🇱Konin, Poland
Oncology Medisch Centrum
🇳🇱Leeuwarden, Netherlands
UMC St.Radboud
🇳🇱Nijmegen, Netherlands
Oncology Maasstad Ziekenhuis
🇳🇱Rotterdam, Netherlands
INSTYTUT im. Marii Sklodowskiej-Curie
🇵🇱Warszawa, Poland
Centrum Medyczne Ostrobramska
🇵🇱Warszawa, Poland
Centro Hospitalar de Lisboa Norte, E.P.E - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
🇵🇱Wroclaw, Poland
Hospital da Luz
🇵🇹Lisboa, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E
🇵🇹Porto, Portugal
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Institute of Oncology and Radiology of Serbia
🇷🇸Belgrade, Serbia
KBC Bezanijska Kosa
🇷🇸Belgrade, Serbia
Urologicka ambulancia CUIMED s.r.o.
🇸🇰Bratislava, Slovakia
Privatna urologicka ambulancia
🇸🇰Trencin, Slovakia
UROX s.r.o.
🇸🇰Piestany, Slovakia
Hospital Universitario Príncipe de Asturias
🇪🇸Alcalá de Henares, Spain
Hospital Clinic I Provincial de Barcelona
🇪🇸Barcelona, Spain
Hosp. Clinico Univ. San Carlos
🇪🇸Madrid, Spain
Instituto de Investigaciones Sanitarias (IIS), Fundacíon Jimenez Díaz (FJD)
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Maranón
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
🇪🇸Madrid, Spain
University Hospital Umeå, Dept Oncology
🇸🇪Umeå, Sweden
Hospital Carlos Haya
🇪🇸Malaga, Spain
Centro Integral Oncológico Clara Campal (CIOCC)
🇪🇸Madrid, Spain
Hospital Universitario Quiron Madrid
🇪🇸Pozuelo de Alarcón, Spain
The Clatterbridge Cancer Centre
🇬🇧Bebington, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, United Kingdom
Örebro University Hospital
🇸🇪Örebrö, Sweden
Royal Free Hospital
🇬🇧London, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
St. Luke's Cancer Centre Royal Surrey County Hospital NHS Foundation Trust
🇬🇧Guildford, United Kingdom
Northern Centre for Cancer Care, Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States