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

• Conditions: Patients with relapse of prostate cancer.

• Registration Number: EUCTR2006-001128-38-SE
• Lead Sponsor: ppsala University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 18

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 metastastatic prostate cancer.
•Karnofsky performance status minimum 80.
•Adequate organ function:
oAST and ALT <2.0 x upper limit of normal (ULN); total serum bilirubin <1.5 x ULN
oCalcium <2.6 mmol/L, serum creatinine <1.5 x ULN
oHb >100 g/L; absolute leukocyte count >3.0 x 109 /L; platelets >100 x 109 /L
•Life expectancy > or equal to 12 months.
•Swedish or English speaking subjects only.
•Written informed consent (subjects must be capable of providing their own informed consent)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.
•Immunosupppressed (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 judgment, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified