Clinical trial · Interventional
Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer
Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Combination With Hormone Therapy in Patients With Metastatic Prostate Cancer
NCT02107391CI-TRIAL-00027787completedPhase 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 hormone therapy can improve PSA progression times for patients with Metastatic 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dendritic Cells DCVAC/PCa | Biological | — | UNRESOLVED |
| Goserelin Acetate | Drug | Goserelin | ALIAS |
| Leuprolide acetate | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DCVAC/PCA added Standard Hormone Therapy
- description
- Combination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy
- interventionNames
- Biological: Dendritic Cells DCVAC/PCa
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care Hormone Therapy
- description
- Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate
- interventionNames
- Drug: Leuprolide acetate
- Drug: Goserelin Acetate
Primary outcomes (1)
- measure
- Proportion of patients with PSA Progression
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 * Presence of bone or soft tissue metastasis (by CT or PET or MRI and/or scintigraphy) * Androgen deprivation therapy using Luteinizing-hormone-releasing hormone ( LHRH) analogues commenced at least one month and at most three months prior randomization or orchiectomy performed at least one month and at most three months prior randomization * Serum testosterone level at screening (≤ 1.7 nmol/l, resp. ≤ 50 ng/dL) * Eastern Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: * Confirmed brain and/or leptomeningeal metastases * Prior or ongoing chemotherapy 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.