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

A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men With Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Biological: DCVAC/PCa; Biological: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 1182
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Universitatsklinikum fur Urologie und Andrologie
  • Wien, Austria, 1020
    • Krankenhaus Barmherzige Brueder
  • Wien, Austria, 1090
    • AKH Universitatskrankenhaus Wien
• Belarus
  • Lesnoy, Belarus, 223040
    • N.N. Alexandrov National Research Center
  • Minsk, Belarus, 220013
    • Minsk City Oncological Hospital
• Belgium
  • Brussels, Belgium, 01000
    • Clinique d'Oncologie Medicale Institut Jules Bordet
  • Brussels, Belgium, 01070
    • Erasme Hospital- Urologie
  • Brussels, Belgium, 01200
    • Cliniques Universitaires Saint Luc- Urologie
  • Gent, Belgium, 09000
    • Urologie UZ Gent
  • Turnhout, Belgium, 02300
    • Urology Department St. Elizabeth Ziekenhuis
• Bulgaria
  • Haskovo, Bulgaria, 6300
    • Specialized Hospital for Active Treatment in Oncology
  • Plovdiv, Bulgaria, 4000
    • Central Oncology Hospital
  • Plovdiv, Bulgaria, 4000
    • Complex Oncology Center
  • Sofia, Bulgaria, 1303
    • Multifunctional Hospital for Active Treatment Serdika
  • Sofia, Bulgaria, 1784
    • Specialized Hospital for Active Treatment of Oncology Diseases
• Croatia
  • Varaždin, Croatia, 42000
    • General Hospital Varazdin
  • Zagreb, Croatia, 10000
    • Clinical Hospital Center Zagreb
  • Zagreb, Croatia, 10000
    • University Hospital Center Sisters of Charity
• Czechia
  • Chomutov, Czechia, 430 12
    • Onkologicke centrum, Nemocnice Chomutov
  • Hradec Kralove, Czechia, 500 05
    • Klinika onkologie a radioterapie, Fakultni nemocnice
  • Jihlava, Czechia, 586 33
    • Nemocnice Jihlava, urologicke oddeleni
  • Liberec, Czechia, 46003
    • Urologicke oddeleni, Krajska nemocnice
  • Olomouc, Czechia, 775 20
    • Onkologicka klinika, Fakultni nemocnice
  • Ostrava-Poruba, Czechia, 708 52
    • Klinika onkologicka, Fakultni nemocnice
  • Prague, Czechia, 100 34
    • Fakultní nemocnice Královské Vinohrady
  • Prague, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Prague, Czechia, 12 808
    • Vseobecna Fakultni Nemocnice V Praze
  • Prague, Czechia, 140 00
    • Thomayerova nemocnice
  • Usti nad Labem, Czechia, 401 13
    • Krajska zdravotni, urologicke oddeleni
• Denmark
  • Copenhagen, Denmark, 02100
    • Rigshospitalet
• France
  • Paris, France, 75 010
    • St-Louis IDF Medical Oncology
  • Paris, France, 75 014
    • Hôpital St. Joseph
  • Paris, France, 75014
    • Hospital Cochin, Service de Urologie
  • Paris Cedex 15, France, 75908
    • HEGP medical oncology
  • Saint Mandé, France, 94160
    • HIA Begin
  • Strasbourg, France, 67091
    • Hospital Civil de Strasbourg
• Germany
  • Berlin, Germany, 12200
    • Charite Universitatsklinikum Berlin
  • Braunschweig, Germany, 38126
    • Städtisches Klinikum Braunschweig
  • Dresden, Germany, 01307
    • Universtatsklinikum Carl Gustav Carus
  • Erlangen, Germany, 91054
    • Waldkrankenhaus St. Marien
  • Frankfurt, Germany, 60 439
    • Krankenhaus Nordwest
  • Halle, Germany, 06120
    • Universitatsklinikum Halle (Saale)
  • Hamburg, Germany, 22763
    • Asklepios-Klinik Hamburg-Altona
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Hannover, Germany, 30 559
    • Vinzenkrankenhaus Hannover
  • Jena, Germany, 07743
    • Universitatskinikum Jena
  • Köln, Germany, 50937
    • Klinik und Poliklinik Urologie
  • Mannheim, Germany, 68167
    • Universitätsmedizin Mannheim
  • Münster, Germany, 48 149
    • Universtatsklinikum Munster
  • Nürtingen, Germany, 72622
    • Studienpraxis Urologie
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg AöR
  • Tübingen, Germany, 72076
    • Universitastsklinikum Tubingen
  • Ulm, Germany, 89075
    • Universitätsklinikum Ulm
  • Westerstede, Germany, 26655
    • Ammerland Klinik fur Urologie
  • Wilhelmshaven, Germany, 26389
    • Praxigemeinschaft fur Onkologie und Urologie
• Hungary
  • Budapest, Hungary, H-1062
    • Magyar Honvedseg Egeszsegugyi Kozpont
  • Budapest, Hungary, H-1097
    • Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeszet
  • Budapest, Hungary, H-1106
    • Bajcsy-Zsilinsky Korhaz
  • Szolnok, Hungary, H-5004
    • Jasz-Nagykun-Szolnok Megyei
• Italy
  • Aviano, Italy
    • CRO Aviano
  • Catania, Italy, 95123
    • A.O.U. Policlinico Vittorio Emanuele
  • Cremona, Italy, 26100
    • A.O. Istituti Ospitalieri di Cremona
  • Cuneo, Italy, 12100
    • A.O. Santa Croce e Carle Oespedale
  • Rome, Italy, 00161
    • Università di Roma Sapienza
  • Sienna, Italy, 53100
    • Azienda Ospedialiera Universitaria Senese
  • Taormina, Italy, 98039
    • Oncologia medica Ospedale S. Vincenzo
• Latvia
  • Riga, Latvia, LV-1079
    • Paula Stradina Kliniska Universitates slimnica
• Lithuania
  • Kaunas, Lithuania, 50009
    • Lithuanian University of Health Science Oncology Institute
  • Klaipeda, Lithuania, 92288
    • Klaipeda university hospital
  • Vilnius, Lithuania, 08660
    • National Cancer Institute
  • Vilnius, Lithuania, 08 661
    • Vilnius University Hospital
• Netherlands
  • Amsterdam, Netherlands, 1007 MB
    • VU Medical Center
  • Assen, Netherlands, 9401 RK
    • Wilhemina Ziekenhuis
  • Hilversum, Netherlands, 1213 XZ
    • Tergooi ziekenhuizen
  • Hoofddorp, Netherlands, 2134 TM
    • Spaarne Gasthuis
  • Leeuwarden, Netherlands, 08934
    • Oncology Medisch Centrum
  • Nijmegen, Netherlands, 06525
    • UMC St.Radboud
  • Rotterdam, Netherlands, 03079
    • Oncology Maasstad Ziekenhuis
• Poland
  • Konin, Poland, 62-500
    • Przychodnia Lekarska (KOMED)
  • Lodz, Poland, 93-513
    • Szpital im M.Kopernika
  • Warszawa, Poland, 02-781
    • Instytut im. Marii Sklodowskiej-Curie
  • Warszawa, Poland, 04-125
    • Centrum Medyczne Ostrobramska
  • Wroclaw, Poland, 50-556
    • Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
• Portugal
  • Lisboa, Portugal, 1500-650
    • Hospital da Luz
  • Lisboa, Portugal, 1645-039
    • Centro Hospitalar de Lisboa Norte, E.P.E - Hospital de Santa Maria
  • Porto, Portugal, 4200-319
    • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Institute of Oncology and Radiology of Serbia
  • Belgrade, Serbia, 11000
    • CHC Zemun
  • Belgrade, Serbia, 11080
    • KBC Bezanijska Kosa
• Slovakia
  • Bratislava, Slovakia, 851 01
    • J.Breza MEDICAL s.r.o.
  • Bratislava, Slovakia, 851 05
    • Urologicka ambulancia CUIMED s.r.o.
  • Martin, Slovakia, 036 59
    • Univerzitna Nemocnica Martin
  • Nitra, Slovakia, 949 01
    • Urologicka ambulancia Uroexam, spol. s r.o.
  • Piestany, Slovakia, 921 01
    • UROX s.r.o.
  • Presov, Slovakia, 080 01
    • Urocentrum MILAB s.r.o.
  • Trencin, Slovakia, 911 01
    • Privátna urologická ambulancia
  • Zilina, Slovakia, 012 07
    • Fakultna nemocnica s poliklinikou Zilina
• Spain
  • Alcalá de Henares, Spain, 28805
    • Hospital Universitario Principe de Asturias
  • Barcelona, Spain, 08035
    • Hospital Clinic i Provincial de Barcelona
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28050
    • Centro Integral Oncológico Clara Campal (CIOCC)
  • Madrid, Spain, 28222
    • Hospital Universitario Puerta de Hierro de Majadahonda
  • Madrid, Spain, 28040
    • Hosp. Clinico Univ. San Carlos
  • Madrid, Spain, 28040
    • Instituto de Investigaciones Sanitarias (IIS), Fundacíon Jimenez Díaz (FJD)
  • Malaga, Spain, 29010
    • Hospital Carlos Haya
  • Pozuelo de Alarcón, Spain, 28223
    • Hospital Universitario Quiron Madrid
• Sweden
  • Umeå, Sweden, 901 85
    • University Hospital Umeå, Dept Oncology
  • Örebrö, Sweden, SE-701 85
    • Örebro University Hospital
• United Kingdom
  • Bebington, United Kingdom, CH63 4JY
    • The Clatterbridge Cancer Centre
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Haematology and Oncology Centre
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust
  • Guildford, United Kingdom, GU2 7XX
    • St. Luke's Cancer Centre Royal Surrey County Hospital NHS Foundation Trust
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Northern Centre for Cancer Care, Freeman Hospital
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • University of South Alabama Mitchell Cancer Institute
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Cancer & Research Centers
    • Scottsdale, Arizona, United States, 85259-5499
      • Mayo Clinic
  • California
    • Corona, California, United States, 92879
      • Compassionate Care Research Group, Inc.
    • Encinitas, California, United States, 92024
      • California Cancer Associates for Research and Excellence
    • Fountain Valley, California, United States, 92708
      • Compassionate Care Research Group, Inc.
    • Fullerton, California, United States, 92835
      • St. Joseph Heritage Healthcare
    • Los Angeles, California, United States, 90033
      • Hao Wei Zhang, MD, LLC
    • Rancho Mirage, California, United States, 92270
      • Desert Hematology Oncology Medical Group
    • Riverside, California, United States, 92501
      • Compassionate Care Research Group, Inc.
    • San Diego, California, United States, 92123
      • Sharp Clinical Oncology Research
    • Whittier, California, United States, 90603
      • Oncology Institute of Hope and Innovation
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale Cancer Center
    • Norwich, Connecticut, United States, 06360
      • Eastern CT Hematology and Oncololgy Associates
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Miami, Florida, United States, 33136
      • Univ. of Miami, Sylvester Comprehensive Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University
  • Kansas
    • Kansas City, Kansas, United States, 64111
      • Saint Luke's Cancer Institute
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center & Medical Pavilion
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Greenebaum Cancer Center
    • Rockville, Maryland, United States, 20850
      • Associates In Oncology/Hematology,P.C
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Detroit, Michigan, United States, 48202
      • Karmanos Cancer Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology, P.A.
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists
    • Omaha, Nebraska, United States, 68130
      • GU Research Network
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Comprehensive Cancer Research Centers of Nevada
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • New Jersey Hematology Oncology Associates
    • Lawrenceville, New Jersey, United States, 08648
      • Premier Urology Associates, LLC / AdvanceMed Research
    • New Brunswick, New Jersey, United States, 08901
      • Cancer Institute of New Jersey
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • UC Health University of Cincinnati
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Tualatin, Oregon, United States, 97062
      • Northwest Cancer Specialists, P.C.
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of Southeastern Pennsylvania
    • Easton, Pennsylvania, United States, 18045
      • Cancer Care Associates St. Luke's University and Health Network
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Cancer Center
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Associates in Oncology & Hematology
  • Texas
    • Arlington, Texas, United States, 76012
      • Arlington Cancer Center
    • Houston, Texas, United States, 77030
      • UT Health, Internal Medicine, Division of Oncology
    • Plano, Texas, United States, 75093
      • Texas Health Physicians Group
    • San Antonio, Texas, United States, 78217
      • Cancer Care Network of South Texas
    • Tyler, Texas, United States, 75701
      • Tyler Hematology Oncology
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists
  • Virginia
    • Fort Belvoir, Virginia, United States, 22060
      • Fort Belvoir Community Hospital
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98012
      • Virginia Mason Medical Center
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties, PLLC
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Mary Babb Randolph Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion criteria:

• Male 18 years and older.
• Histologically or cytologically confirmed prostate adenocarcinoma.

• Presence of skeletal, or soft-tissue/visceral/nodal metastases according to one of the following criteria:

  • Confirmed pathological fracture related to the disease OR
  • Confirmation of distant bone and/or soft-tissue and/or visceral metastases on CT or MRI scan or bone scintigraphy OR
  • Positive pathology report of metastatic lesion

• Disease progression despite androgen-deprivation therapy (ADT) as indicated by:

  • Prostate-specific antigen (PSA) increase that is ≥ 2 ng/mL and ≥ 25% above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed and which is confirmed by a second value 1 or more weeks later OR
  • Progression of measurable lymph nodes (short axis ≥ 15 mm) or visceral lesion measurable per RECIST v1.1 criteria, confirmation by an independent review facility (IRF) required OR
  • Two or more new lesions appearing on bone scan/imaging compared with a previous scan (confirmation by IRF required)
• Maintenance of castrate conditions: patients, who have not had a surgical orchiectomy, must continue with hormone therapy with gonadotropin releasing hormone/ luteinizing hormone-releasing hormone (GnRH/LHRH) agonists or antagonists to reach levels of serum testosterone of ≤ 1.7 nmol/L (50 ng/dL). The duration of the castration period must be at least 4 months before screening as evidenced by combination of clinical/laboratory data (see section 6.8.1).

• Laboratory criteria:

  • White blood cells (WBC) greater than 4,000/mm3 (4.0 x109/L)
  • Neutrophil count greater than 1,500/mm3 (1.5 x109/L).
  • Hemoglobin of at least 10 g/dL (100 g/L).
  • Platelet count of at least 100,000/mm3 (100 x 109/L).
  • Total bilirubin within normal limits (benign hereditary hyperbilirubinemias, e.g. Gilbert's syndrome, are permitted).
  • Serum alanine aminotransferase, aspartate aminotransferase, and creatinine < 1.5x times the upper limit of normal (ULN).
• Life expectancy of at least 6 months based on Investigator's judgment.
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
• At least 4 weeks after surgery or radiotherapy before randomization.
• A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy before randomization.
• Recovery from primary local surgical treatment, radiotherapy or orchiectomy before randomization.
• Signed informed consent including patient's ability to comprehend its contents.

Exclusion criteria:

• Confirmed brain and/or leptomeningeal metastases (other visceral metastases are acceptable).
• Current symptomatic spinal cord compression requiring surgery or radiation therapy.
• Prior chemotherapy for prostate cancer.

• Patient co-morbidities:

  • Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone).
  • HIV positive, human T-lymphotropic virus positive.
  • Active hepatitis B (active hepatitis B), active hepatitis C (HCV), active syphilis.
  • Evidence of active bacterial, viral or fungal infection requiring systemic treatment.

  • Clinically significant cardiovascular disease including:

    • symptomatic congestive heart failure.
    • unstable angina pectoris.
    • serious cardiac arrhythmia requiring medication.
    • uncontrolled hypertension.
    • myocardial infarction or ventricular arrhythmia or stroke within a 6 months before screening, known left ventricular ejection fraction (LVEF) < 40% or serious cardiac conduction system disorders, if a pacemaker is not present.
  • Pleural and pericardial effusion of any NCI CTCAE grade.
  • Peripheral neuropathy having a NCI CTCAE ≥ grade 2.
  • History of malignant disease (with the exception of non-melanoma skin tumors) in the preceding five years.
  • Active autoimmune disease requiring treatment.
  • History of severe forms of primary immune deficiencies.
  • History of anaphylaxis or other serious reaction following vaccination.
  • Known hypersensitivity to any constituent of the DCVAC/PCa or placebo product.
  • Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator's opinion, would prevent participation in the trial.
• Systemic corticosteroids at doses greater than 40 mg hydrocortisone daily or equivalent for any reason other than treatment of PCa within 6 months before randomization.
• Ongoing systemic immunosuppressive therapy for any reason.
• Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumor-focused treatment performed on the day of randomization (except for GnRH/LHRH agonists or antagonists) to exclude possible anti-androgen withdrawal response. This criterion is not applicable to subjects who have never responded to anti-androgen treatment, as there is no risk of anti-androgen withdrawal response.
• Treatment with immunotherapy against PCa within 6 months before randomization.
• Treatment with radiopharmaceutical within 8 weeks before randomization.
• Participation in a clinical trial using non-immunological experimental therapy within 4 weeks before randomization.
• Participation in a clinical trial using immunological experimental therapy (e.g., monoclonal antibodies, cytokines or active cellular immunotherapies) within 6 months before randomization.
• Refusal to sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCVAC/PCa with standard of care chemotherapy; Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)	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.; Other Names: Stapuldencel
Placebo Comparator: Placebo with standard of care chemotherapy; Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival, Intention-to-treat Population	Overall survival is defined as the time from randomization until death due to any cause.	From randomization to death due to any cause, up to 58 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival, Per Protocol Population	Overall survival is defined as the time from randomization until death due to any cause.	From randomization to death due to any cause, up to 58 months
Overall Survival, Intention-to-treat Population, Abiraterone as Prior Therapy	Overall survival is defined as the time from randomization until death due to any cause.	From randomization to death due to any cause, up to 58 months
Overall Survival, Intention-to-treat Population, Enzalutamide as Prior Therapy	Overall survival is defined as the time from randomization until death due to any cause.	From randomization to death due to any cause, up to 58 months
Overall Survival, Intention-to-treat Population, no Prior Abiraterone or Enzalutamide	Overall survival is defined as the time from randomization until death due to any cause.	From randomization to death due to any cause, up to 58 months
Radiological Progression-free Survival, Intention-to-treat Population	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 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
Radiological Progression-free Survival, Per Protocol Population	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 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
Time to PSA Progression, Intention-to-treat Population	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 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
Time to PSA Progression, Per Protocol Population	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 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
Time to First Skeletal-related Event, Intention-to-treat Population	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	Time from randomization to the date of the first skeletal-related event, up to 58 months
Time to First Skeletal-related Event, Per Protocol Population	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	Time from randomization to the date of the first skeletal-related event, up to 58 months
Time to Radiological Progression or Skeletal-related Event, Intention-to-treat Population	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	Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months
Time to Radiological Progression or Skeletal-related Event, Per Protocol Population	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	Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months
Proportion of Patients With Skeletal-related Events, Intention-to-treat Population	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	From randomization to the end of the study, up to 57 months
Proportion of Patients With Skeletal-related Events, Per Protocol Population	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	From randomization to the end of the study, up to 57 months

Collaborators and Investigators

• Sponsor: SOTIO a.s.
• Investigators: Principal Investigator: Nicholas J. Vogelzang, US Oncology Research/Comprehensive Cancer Centers of Nevada

Publications and helpful links

General Publications

• Hensler M, Rakova J, Kasikova L, Lanickova T, Pasulka J, Holicek P, Hraska M, Hrnciarova T, Kadlecova P, Schoenenberger A, Sochorova K, Rozkova D, Sojka L, Drozenova J, Laco J, Horvath R, Podrazil M, Hongyan G, Brtnicky T, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Garg AD, Cibula D, Bartunkova J, Spisek R, Fucikova J. Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines. Oncoimmunology. 2022 Jul 22;11(1):2101596. doi: 10.1080/2162402X.2022.2101596. eCollection 2022.
• Vogelzang NJ, Beer TM, Gerritsen W, Oudard S, Wiechno P, Kukielka-Budny B, Samal V, Hajek J, Feyerabend S, Khoo V, Stenzl A, Csoszi T, Filipovic Z, Goncalves F, Prokhorov A, Cheung E, Hussain A, Sousa N, Bahl A, Hussain S, Fricke H, Kadlecova P, Scheiner T, Korolkiewicz RP, Bartunkova J, Spisek R; VIABLE Investigators. Efficacy and Safety of Autologous Dendritic Cell-Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer: The VIABLE Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):546-552. doi: 10.1001/jamaoncol.2021.7298.

Helpful Links

• Click here for more information about this study: Phase III Study of DCVAC Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (VIABLE)

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2014
• Primary Completion (Actual): January 28, 2020
• Study Completion (Actual): January 28, 2020

Study Registration Dates

• First Submitted: April 9, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 11, 2014

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Vaccine; Immunotherapy; Prostate cancer; Metastatic; Biological; Castration-resistant
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: SP005; 2012-002814-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO