This trial is active, not recruiting.

Condition prostate cancer
Treatment dendritic cells dcvac/pca
Phase phase 2
Sponsor Sotio a.s.
Start date April 2012
End date June 2015
Trial size 150 participants
Trial identifier NCT02107404, SP003


The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA doubling times for patients with localized Prostate Cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Dendritic Cells DCVAC/PCA Experimental therapy
dendritic cells dcvac/pca
DCVAC/PCa Experimental therapy
(No Intervention)
No Intervention

Primary Outcomes

Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40
time frame: 40 Weeks

Secondary Outcomes

Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization
time frame: 104 Weeks
Frequency of Adverse Events
time frame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Proportion of Patients with Objective disease progression within 2 years
time frame: 104 Weeks
Number of Patients requiring further therapy at 2 years
time frame: 104 Weeks
Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization
time frame: 104 Weeks
Proportion of patients after RPE with biochemical relapse within 2 years of randomization
time frame: 104 Weeks
Proportion of patients with progressive increase in PSA within 2 years of randomization
time frame: 104 Weeks
Overall survival
time frame: 104 Weeks

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Male 18 years and older - Histologically confirmed pT2 prostate cancer - Post radical prostatectomy - PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months - Salvage radiotherapy naïve with PSA increase within 2 years or after salvage radiotherapy with PSA not higher than 1 ng/ml - Eastern Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: - Confirmed brain and/or leptomeningeal metastases - Prior androgen deprivation therapy or orchiectomy for prostate cancer - Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater - Other uncontrolled intercurrent illness - Treatment with immunotherapy against prostate cancer - Clinically significant cardiovascular disease - Active autoimmune disease requiring treatment

Additional Information

Official title Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial With Active Cellular Immunotherapy DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sotio a.s..