Phase II Study of DCVAC/PCa After Primary Radiotherapy for Patients With High Risk Localized Prostate Cancer

Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Localized High-risk Prostate Cancer After Primary Radiotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02107430

Enrollment

Registered

2014-04-08

Start date

2012-03-31

Completion date

2018-10-31

Last updated

2018-11-14

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 progression times within 5 years for patients with high risk localized Prostate Cancer.

Detailed description

Treatment post radical primary prostatectomy Treatment post standard radiotherapy

Interventions

BIOLOGICALDendritic Cells DCVAC/PCa

DCVAC/PCa arm post radiotherapy

RADIATIONStandard radiotherapy

radiotherapy

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 localized prostate cancer of high risk or very high risk fulfilling at least one of the following: T3-T4 stage or Gleason Score 8-10 or PSA level above 20 ng/ml * Indication for prostate cancer radical radiotherapy * Neo-adjuvant androgen androgen-deprivation therapy due to prostate cancer using Luteinizing-hormone-releasing hormone (LHRH) analogues ongoing for at least two months and not longer than 12 months prior randomization * Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion criteria

* Primary surgical treatment of prostate cancer * Prior or ongoing chemotherapy for prostate cancer * Participation in other clinical study or administration of other evaluated drug within 30 day prior screening * Unresolved lasting obstruction of urinary system * Other uncontrolled inter-current illness * Treatment with immunotherapy against Prostate Cancer * Clinically significant cardiovascular disease * History of primary immunodeficiency * Active autoimmune disease requiring treatment

Design outcomes

Primary

Measure	Time frame	Description
Number of Prostate Specific Antigen (PSA) failures in 5 years	Enrollment up to 260 weeks	PSA failure per Phoenix criteria of increase of 2ng/mL over nadir

Secondary

Measure	Time frame	Description
Proportion of Patients without use of salvage therapy within 5 years	Enrollment up to 260 weeks	Calculation of the proportion of patients without use of salvage therapy within 5 years
Frequency of Adverse Events	enrollment up to 260 weeks	Safety profile as defined by the nature, incidence, duration, severity and outcome of adverse events
Proportion of Patients without Objective disease progression within 5 years	Enrollment up to 260 weeks	Proportion of patients who do not have a \>2ng/mL elevation in PSA or require salvage therapy

Countries

Czechia

Outcome results

None listed

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