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.