Clinical trial · Interventional
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
NCT02105675CI-TRIAL-00027760completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dendritic Cells DCVAC/PCa | Biological | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DCVAC/PCa add on to Standard of Care
- description
- Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care
- interventionNames
- Biological: Dendritic Cells DCVAC/PCa
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- Docetaxel as an Active Comparator
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Survival rate
- timeFrame
- 135 weeks
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.