Clinical trial · Interventional
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
NCT02137746CI-TRIAL-00027781completedPhase 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 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.
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 (1)
- type
- EXPERIMENTAL
- label
- DCVAC/PCa Arm
- description
- Dendritic Cells DCVAC/PCa Experimental therapy
- interventionNames
- Biological: Dendritic Cells DCVAC/PCa
Primary outcomes (1)
- measure
- Safety evaluation of the second cycle of DCVAC
- timeFrame
- 52 weeks
- description
- 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 outcomes (1)
- measure
- Time to Prostate Specific Antigen (PSA) Doubling Time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.