Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02137746

Enrollment

Registered

2014-05-14

Start date

2013-12-31

Completion date

2017-03-20

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

Prostate Cancer, Radical Prostatectomy

Brief summary

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.

Detailed description

Same as brief summary

Interventions

BIOLOGICALDendritic Cells DCVAC/PCa

DCVAC/PCa Experimental therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

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 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

Design outcomes

Primary

Measure	Time frame	Description
Safety evaluation of the second cycle of DCVAC	52 weeks	Safety evaluation of the second cycle of active cellular immunotherapy, which includes a second leukapheresis procedure, who after primary radical prostatectomy completed first cycle of active cellular immunotherapy in clinical trial SP003 without objective disease progression requiring additional anti-tumor therapy.

Secondary

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

Countries

Czechia

Outcome results

None listed

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