This trial is active, not recruiting.

Condition prostate cancer
Treatment dendritic cells dcvac/pca
Phase phase 2
Sponsor Sotio a.s.
Start date December 2013
End date April 2015
Trial size 24 participants
Trial identifier NCT02137746, 2013-003809-26, SP010


The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an objective progression of the disease.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Dendritic Cells DCVAC/PCa Experimental therapy
dendritic cells dcvac/pca
DCVAC/PCa Experimental therapy

Primary Outcomes

Safety evaluation of the second cycle of DCVAC
time frame: 52 weeks

Secondary Outcomes

Time to Prostate Specific Antigen (PSA) Doubling Time
time frame: 52 weeks

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Male 18 years and older - Histologically confirmed prostate adenocarcinoma Stage pathological tumor-2 (pT2) - Post radical Primary Prostatectomy - Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease Exclusion Criteria: - Prior androgen deprivation therapy for prostate cancer - Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater - Other uncontrolled intercurrent illness - Treatment with immunotherapy against PCa - Clinically significant cardiovascular disease - Active autoimmune disease requiring treatment

Additional Information

Official title Open-label, One-arm, Multi-centre Phase II Clinical Trial Treated With Second Cycle of Active Cellular Immunotherapy With DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy Without Objective Progression
Description Same as brief summary
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sotio a.s..