Know Cancer

forgot password

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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

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

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

- 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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the feasibility and safety of escalating doses of pVAXrcPSAv53l DNA vaccine, administered intradermally in combination with electroporation in patients with relapse of prostate cancer.

Outcome Time Frame:

From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination

Safety Issue:


Principal Investigator

Jeffrey Yachnin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, University Hospital Uppsala


Sweden: Medical Products Agency

Study ID:

pVAX/rhPSA -EP 2006



Start Date:

December 2008

Completion Date:

September 2011

Related Keywords:

  • Prostate Cancer
  • DNA
  • Vaccine
  • Electroporation
  • xenogenic
  • PSA
  • Prostatic Neoplasms