Clinical trial · Interventional
Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer
Dendritic Cell Vaccination in Combination With Docetaxel for Patients With Cancer Prostate - a Randomized Phase II Study
- 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)
This is a randomized phase II trial including 40 patients with castration resistant metastatic cancer prostate (CRMPC). Patients will be randomized between treatment with a dendritic cell vaccine plus docetaxel and docetaxel alone. The primary objective is to evaluate the vaccine specific immune response and patients will be evaluated with blood tests and DTH reactions during the treatment course. Secondary objectives are to evaluate clinical response by objective response (RECIST-criteria, 18F-NaF-PET/CT scan), PSA response, pain response and finally we determine time to progression and overall survival.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| mRNA transfected dendritic cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- DC vaccine (mRNA transfected dendritic cell) + Docetaxel
- interventionNames
- Biological: mRNA transfected dendritic cell
- Drug: Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Docetaxel alone
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Number of Patients With Immunological Response
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological verified CRMPC in progression, defined by 1. RECIST-criteria and/or 2. PSA increase to more than baseline in two consecutive measurements 2. Treatment with Docetaxel is indicated 3. Age \> 18 years old 4. ECOG performance status ≤2 5. Life expectancy \> 3 months 6. Normal organ function Exclusion Criteria: 1. Other malignant tumors 2. Severe heard or lung disorders 3. Infection with HIV, hepatitis, tuberculosis. 4. Severe allergy or previous anaphylactic reactions 5. Active autoimmune disease 6. Treatment with immunosuppressive drugs (including prednisolon, methotrexate)7. Co-treatment with other experimental treatments, other antineoplastic treatment.
References
Publications (0)
Data not yet available