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Trial record 1 of 1 for:    NCT02111577
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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 April 2017 by Sotio a.s.
Information provided by (Responsible Party):
Sotio a.s. Identifier:
First received: April 9, 2014
Last updated: April 24, 2017
Last verified: April 2017
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Radiographic Progression Free Survival [ Time Frame: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 weeks ]
  • Duration to Prostate Specific Antigen (PSA) Progression [ Time Frame: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 weeks ]
  • 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 ]

Estimated Enrollment: 1170
Study Start Date: April 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: September 2018 (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)
Sexes 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 194 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 ( EudraCT Number )
Study First Received: April 9, 2014
Last Updated: April 24, 2017
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
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017