Clinical trial · Interventional
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
NCT02107404CI-TRIAL-00027789completedPhase 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 after radical primary prostatectomy can improve PSA doubling times for patients with localized Prostate Cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dendritic Cells DCVAC/PCa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DCVAC/PCa Arm
- description
- Dendritic Cells DCVAC/PCA Experimental therapy
- interventionNames
- Biological: Dendritic Cells DCVAC/PCa
- type
- NO_INTERVENTION
- label
- Standard Therapy
- description
- No Intervention
Primary outcomes (1)
- measure
- Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40
- timeFrame
- 40 Weeks
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.