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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.
Verified April 2017 by Sotio a.s.
Sponsor:
Sotio a.s.
Information provided by (Responsible Party):
Sotio a.s.
ClinicalTrials.gov Identifier:
NCT02111577
First received: April 9, 2014
Last updated: April 24, 2017
Last verified: April 2017
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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:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
Drug Information available for:
Docetaxel
U.S. FDA Resources
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| 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
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 ClinicalTrials.gov identifier: NCT02111577
Show 194 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02111577
Contacts
| Contact: Richard Kapsa | 420-224-174-448 | kapsa@sotio.com |
Show 194 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 ) |
| Study First Received: | April 9, 2014 |
| Last Updated: | April 24, 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 |
ClinicalTrials.gov processed this record on August 18, 2017