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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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02111577
First Posted: April 11, 2014
Last Update Posted: October 18, 2017
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.
Information provided by (Responsible Party):
Sotio a.s.
  Purpose
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: Triple (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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111577


  Show 167 Study Locations
Sponsors and Collaborators
Sotio a.s.
Investigators
Study Director: Rostislav Kuklik, MD Sotio a.s.
  More Information

Additional Information:
Responsible Party: Sotio a.s.
ClinicalTrials.gov Identifier: NCT02111577     History of Changes
Other Study ID Numbers: SP005
2012-002814-38 ( EudraCT Number )
First Submitted: April 9, 2014
First Posted: April 11, 2014
Last Update Posted: October 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sotio a.s.:
Immunotherapy
Metastatic
Castrate Resistant
Prostate Cancer
Biological
Vaccine

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisone
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal