Patients with relapse of prostate cancer.
Conditions
Interventions
Product Name: pVAXrcPSAv53l
Product Code: pVAX/rhPSA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BICALUTAMIDE
CAS Number: 90357065
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Uppsala University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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: o AST and ALT 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the feasibility and safety of vaccination with pVAXrcPSAv53l, administered intradermally in combination with electroporation in patients with relapse of prostate cancer.;Secondary Objective: Assess the safety and functionality of the DERMA VAX™ in vivo electroporation DNA vaccine delivery system. Identify optimal application parameters for DERMA VAX™ DNA vaccine delivery system. Identify the variation in human skin resistance to be used in future trials as a quality measure of electric field applied. Evaluate the PSA-specific immune response induced by the vaccine. Evaluate vaccine effect on PSA doubling time Identify an anti-tumor effect of the vaccine. ;Primary end point(s): Primary end point • Safety of pVAXrcPSAv53l, administered intradermally with DERMA VAX™ EP graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0). Secondary end point • Detection of in vitro PSA-specific immune response. • Clinical PSA-response in vivo. • Optimization of application parameters for DERMA VAX™ device Time-to endpoints For the purposes of endpoint definitions, the term “on study” includes the period of androgen deprivation, vaccination and follow-up. Follow-up continues every 6 months until PSA progression or, maximum one (1) year after the patient’s fifth vaccination. Time to PSA progression Is defined - from day 0 when treatment with Bicalutamide is initiated until PSA increases 50 % above the nadir or 25 % over baseline, provided that either increase is a minimum of 3 mg/L. All end dates require a confirmatory PSA. | — |
Countries
Sweden
Outcome results
None listed