Clinical trial · Interventional
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
NCT02107430CI-TRIAL-00035778completedPhase 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 progression times within 5 years for patients with high risk 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dendritic Cells DCVAC/PCa | Biological | — | UNRESOLVED |
| Standard radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DCVAC/PCa arm post radiotherapy
- description
- Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy
- interventionNames
- Biological: Dendritic Cells DCVAC/PCa
- type
- ACTIVE_COMPARATOR
- label
- Standard radiotherapy
- description
- Standard care
- interventionNames
- Biological: Dendritic Cells DCVAC/PCa
- Radiation: Standard radiotherapy
Primary outcomes (1)
- measure
- Number of Prostate Specific Antigen (PSA) failures in 5 years
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.