Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate Cancer

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 reference value on two (2) consecutive occasions at least one month apart and with a minimum of 2 ng/mL above nadir.
• PSA doubling time is one (1) year or less.
• No evidence of metastatic prostate cancer.
• Karnofsky performance status ≥ 80.
• Adequate organ function:

• AST and ALT ≤ 2.0 x upper limit of normal (ULN); total serum bilirubin ≤ 1.5 x ULN
• Calcium ≤ 2.6 mmol/L, serum creatinine ≤ 1.5 x ULN
• Hb ≥ 100 g/L; absolute leukocyte count ≥ 3.0 x 109 /L; platelets ≥100 x 109 /L
• Life expectancy ≥ 12 months.
• Swedish or English speaking subjects only.
• Written informed consent (subjects must be capable of providing their own informed consent).

Exclusion criteria

• Previous ablation of testis.
• Radiologic evidence of metastatic disease.
• Prior chemotherapy or investigational therapy/agents within 4 weeks.
• Active bacterial, viral or fungal infection.
• Carrier of HIV, HBV, or HCV.
• Immunosuppressed (post splenectomy, post stem cell transplantation) or on immunosuppressive therapy other than inhaled or replacement corticosteroids.
• Any other major illness or peripheral blood vein status that, in the investigator's judgement, will substantially increase the risk associated with sampling or participation in this study.
• Subjects with cardiac demand pacemakers.
• Any reason why, in the opinion of the investigator, the patient should not participate.