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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Sotio a.s.
Information provided by (Responsible Party):
Sotio a.s. Identifier:
First received: April 9, 2014
Last updated: September 9, 2016
Last verified: September 2016
The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care Chemotherapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer.

Condition Intervention Phase
Metastatic Castrate Resistant Prostate Cancer
Biological: Dendritic Cells DCVAC
Biological: Placebo
Drug: Docetaxel
Drug: Taxotere
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Sotio a.s.:

Primary Outcome Measures:
  • Overall survival (all cause mortality) [ Time Frame: 124 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Radiographic Progression Free Survival [ Time Frame: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 weeks ] [ Designated as safety issue: No ]
  • Duration to Prostate Specific Antigen (PSA) Progression [ Time Frame: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 weeks ] [ Designated as safety issue: No ]
  • Duration to Skeletal Related Events [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 34, 38, 42, 46, 50, 54, 66, 78, 90, 102, 124 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1170
Study Start Date: April 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCVAC with Standard of Care Chemotherapy
Combination therapy with Dendritic Cells DCVAC and Standard of Care Chemotherapy (Docetaxel and prednisone)
Biological: Dendritic Cells DCVAC
DCVAC is the experimental therapy
Drug: Docetaxel
Docetaxel and prednisone is Standard of Care First Line Chemotherapy
Other Name: Taxotere
Drug: Taxotere
Active Comparator: Standard of Care Chemo and Placebo
Blinded combination therapy of Placebo and Standard of Care Chemotherapy (Docetaxel and prednisone) as Comparator
Biological: Placebo
DCVAC placebo is experimental vaccine placebo
Drug: Docetaxel
Docetaxel and prednisone is Standard of Care First Line Chemotherapy
Other Name: Taxotere
Drug: Taxotere


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male 18 years and older
  • Histologically or cytologically confirmed prostate adenocarcinoma
  • Presence of skeletal, and/or soft-tissue/visceral/nodal metastasis
  • Disease progression despite Androgen Deprivation Therapy
  • Maintenance of castrate conditions
  • 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
  • A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy
  • Recovery from primary local surgical treatment, radiotherapy or orchiectomy

Exclusion Criteria:

  • Confirmed brain and/or leptomeningeal metastases
  • Current symptomatic cord compression requiring surgery or radiation therapy
  • Prior chemotherapy for prostate cancer
  • Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone)
  • Systemic corticosteroids at doses greater than 40mg hydrocortisone daily or equivalent for any reason other than treatment of prostate cancer (PCa) within the previous 6 months
  • Systemic immunosuppressive therapy for any reason
  • Treatment with immunotherapy against PCa within the previous 6 months prior to randomization
  • Clinically significant cardiovascular disease
  • Active autoimmune disease requiring treatment
  • Uncontrolled co-morbidities
  • Participation in a clinical trial using experimental therapy within the last 4 weeks prior to randomization
  • Participation in a clinical trial using immunological experimental therapy (e.g. monoclonal antibodies, cytokines or active cellular immunotherapies) within the last 6 months prior to randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02111577

Contact: Richard Kapsa 420-224-174-448

  Show 187 Study Locations
Sponsors and Collaborators
Sotio a.s.
Study Director: Rostislav Kuklik, MD Sotio a.s.
  More Information

Additional Information:
Responsible Party: Sotio a.s. Identifier: NCT02111577     History of Changes
Other Study ID Numbers: SP005  2012-002814-38 
Study First Received: April 9, 2014
Last Updated: September 9, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Bulgaria: Bulgarian Drug Agency
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
European Union: European Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Paul-Ehrlich-Institut
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Italy: The Italian Medicines Agency
Netherlands: Ministry of Health, Welfare and Sport
Poland: The Central Register of Clinical Trials
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Romania: National Agency for Medicines and Medical Devices
Russia: Ministry of Health of the Russian Federation
Serbia: Medicines and Medical Devices Agency
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Sotio a.s.:
Castrate Resistant
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal processed this record on October 25, 2016