Phase 2
Completed N=43
Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT01446731 ↗Enrolled (actual)
43
Serious AEs
10.0%
Results posted
Jul 2024
Primary outcomePrimary: Number of Patients With Immunological Response — 9 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Immunological Response |
9 | — |
| SECONDARY Number of Patients With PSA Response |
11; 8 | — |
| SECONDARY Number of Patients With Adverse Event Considered Related to the Dendritic Cell Vaccine |
2 | — |
| SECONDARY Progression-free Survival |
5.7; 5.5 | — |
Eligibility Criteria
Inclusion Criteria
- Histological verified CRMPC in progression, defined by
- RECIST-criteria and/or
- PSA increase to more than baseline in two consecutive measurements
- Treatment with Docetaxel is indicated
- Age > 18 years old
- ECOG performance status ≤2
- Life expectancy > 3 months
- Normal organ function
Exclusion Criteria
- Other malignant tumors
- Severe heard or lung disorders
- Infection with HIV, hepatitis, tuberculosis.
- Severe allergy or previous anaphylactic reactions
- Active autoimmune disease
- Treatment with immunosuppressive drugs (including prednisolon, methotrexate)7. Co-treatment with other experimental treatments, other antineoplastic treatment.
Data sourced from ClinicalTrials.gov (NCT01446731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.