Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02105675

Enrollment

Registered

2014-04-07

Start date

2012-02-29

Completion date

2017-02-20

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, Prostate Cancer Metastatic

Keywords

Immunotherapy, Metastatic, Castrate Resistant, Prostate Cancer, Biological, Vaccine

Brief summary

The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer

Interventions

BIOLOGICALDendritic Cells DCVAC/PCa

DCVAC/PCa is the experimental therapy added on to Docetaxel

DRUGDocetaxel

Docetaxel is Standard of Care First Line Chemotherapy

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

* Men aged ≥ 18 years * Histologically confirmed prostate cancer * Presence of skeletal metastasis (by CT or PET or MRI) * Disease progression documented by increasing PSA or two new lesions * Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

Exclusion criteria

* Confirmed brain and/or leptomeningeal metastases * Prior chemotherapy 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
Survival rate	135 weeks

Secondary

Measure	Time frame
Radiographic Progression Free Survival	135 weeks
Duration to Prostate Specific Antigen (PSA) Progression	135 weeks
Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30	0, 10, 22, 37, 53, 65 weeks
Changes in Pain assessed by EORTC QLQ-C30	0, 10, 22, 37, 53, 65 weeks
Incidence of Adverse Events	135 weeks

Countries

Czechia

Outcome results

None listed

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