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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Metastatic Castrate Resistant Prostate Cancer	Biological: Dendritic Cells DCVAC; Biological: Placebo; Drug: Docetaxel; Drug: Taxotere	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1170 participants
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
Study Start Date :	April 2014
Estimated Primary Completion Date :	September 2018
Estimated Study Completion Date :	June 2019

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Overall survival (all cause mortality) [ Time Frame: 124 Weeks ]

Secondary Outcome Measures :

1. Radiographic Progression Free Survival [ Time Frame: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 weeks ]
2. Duration to Prostate Specific Antigen (PSA) Progression [ Time Frame: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 weeks ]
3. 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 ]

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 167 Study Locations

Sponsors and Collaborators

Sotio a.s.

Investigators

Study Director:	Rostislav Kuklik, MD	Sotio a.s.

More Information

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Additional Information:

Click here for more information about this study:Phase III Study of DCVAC Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (VIABLE) 

Responsible Party:	Sotio a.s.
ClinicalTrials.gov Identifier:	NCT02111577 History of Changes
Other Study ID Numbers:	SP005; 2012-002814-38 ( EudraCT Number )
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