Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02107404

Enrollment

150

Registered

2014-04-08

Start date

2012-04-30

Completion date

2017-05-22

Last updated

2017-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Immunotherapy, Prostate Cancer, Biological, Vaccine

Brief summary

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.

Interventions

BIOLOGICALDendritic Cells DCVAC/PCa

DCVAC/PCa Experimental therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Frequency of Adverse Events	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	104 Weeks
Number of Patients requiring further therapy at 2 years	104 Weeks
Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization	104 Weeks
Proportion of patients after RPE with biochemical relapse within 2 years of randomization	104 Weeks
Proportion of patients with progressive increase in PSA within 2 years of randomization	104 Weeks
Overall survival	104 Weeks
Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization	104 Weeks

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026