Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00859729 | Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate Cancer | PHASE1 | COMPLETED | 15 | — | — | Dec 1, 2008 | Nov 1, 2011 | Mar 17, 2014 | 1 | Sweden |
| Arm | Type | Description |
|---|---|---|
| Cohort I | EXPERIMENTAL | 50 µg DNA/dose, 3 patients |
| Cohort II | EXPERIMENTAL | 150 µg DNA/dose, 3 patients |
| Cohort III | EXPERIMENTAL | 400 µg DNA/dose, 3 patients |
| Cohort IV | EXPERIMENTAL | 1000 µg DNA/dose, 3 patients |
| Cohort V | EXPERIMENTAL | Optimal dose to be determined, 6 patients |
| Name | Type | Description |
|---|---|---|
| pVAXrcPSAv53l (DNA encoding rhesus PSA) | BIOLOGICAL | 5 doses, 4 weeks apart |
| DERMA VAX™ intradermal DNA delivery system | DEVICE | in vivo electroporation is applied after each DNA injection |
Inclusion Criteria: * Male patients. Age \>18 years. * HLA-A\*0201 positive. * Histologically confirmed prostate cancer. * Minimum two (2) and maximum four (4) years after treatment with curative or salvage radiotherapy. * Serum testosterone within normal range. * Increasing PSA from a previous ref...