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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02111577
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Sotio a.s.

Tracking Information
First Submitted Date  ICMJE April 9, 2014
First Posted Date  ICMJE April 11, 2014
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date December 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
Overall survival (all cause mortality) [ Time Frame: 124 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Study of DCVAC Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Castrate Resistant Prostate Cancer
Intervention  ICMJE
  • Biological: Dendritic Cells DCVAC
    DCVAC is the experimental therapy
  • 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
Study Arms  ICMJE
  • Experimental: DCVAC with Standard of Care Chemotherapy
    Combination therapy with Dendritic Cells DCVAC and Standard of Care Chemotherapy (Docetaxel and prednisone)
    Interventions:
    • Biological: Dendritic Cells DCVAC
    • Drug: Docetaxel
    • 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
    Interventions:
    • Biological: Placebo
    • Drug: Docetaxel
    • Drug: Taxotere
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2020)
1182
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2014)
1170
Actual Study Completion Date  ICMJE January 28, 2020
Actual Primary Completion Date December 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belarus,   Belgium,   Bulgaria,   Croatia,   Czechia,   Denmark,   France,   Germany,   Hungary,   Italy,   Latvia,   Lithuania,   Netherlands,   Poland,   Portugal,   Serbia,   Slovakia,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Romania,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT02111577
Other Study ID Numbers  ICMJE SP005
2012-002814-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sotio a.s.
Study Sponsor  ICMJE Sotio a.s.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrea Viktorinova, MD Sotio a.s.
PRS Account Sotio a.s.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP