DNA Vaccine Coding for the Rhesus Prostate Specific Antigen (rhPSA) and Electroporation in Patients With Relapsed Prostate Cancer. A Phase I/II Study
- 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
- 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
- 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
- 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