prostate cancer Prostate carcinoma
Conditions
Interventions
Ad[I/PPT-E1A] will be administered 3 weeks prior to radical prostatectomy at
1x10E11, 1x10E12 or 5x10E12 Virus Particles by intraprostatic injection under
guidance of transrectal ultrasound in 4 equ
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men * 18 years, scheduled to undergo radical prostatectomy in Erasmus MC 2. Histologically proven adenocarcinoma of the prostate 3. Clinical Stage T1b-T2, Nx-N0, M0 disease 4. Life expectancy > 10 years according to the European Association of Urology guidelines 2009 5. Written informed consent 6. Haematology: - Absolute neutrophil count ANC * 1.5 x 10E9 /L - Lymphocyte counts * 0.8 x 10E9/L - Platelets * 100 x 10E9 /L - Haemoglobin * 6.2 mmol/L 7. Chemistry: - Aspartate aminotransferase (AST) * 2.5 x ULN - Alanine aminotransferase (ALT) * 2.5 x ULN - Creatinin * 1.5 x ULN - Total bilirubin * 1.5 x ULN 8. Living within one hour travel distance of the hospital 9. Green light from anaesthesist, fit to undergo RP
Exclusion criteria
Exclusion criteria: 1. Prior androgen ablation hormonal therapy (except treatment with finasteride - if discontinued > 3 months prior to inclusion in current protocol) 2. Prior prostatic surgical procedure during which tissue was resected, except biopsies. 3. Continuous daily use of oral prednisone, oral dexamethasone, or other systemic corticosteroids for more than 14 days within 3 months prior to screening (inhaled, nasal and local steroids are allowed (e.g. joint injection) 4. Concurrent treatment with immunosuppressive drugs (Imuran, cyclophosphamide, etc.). 5. Patients with uncontrolled infections, including uncontrolled infections of the urinary tract (defined as viral, bacterial or fungal infections requiring specific therapy) 6. Patients known to be HIV-positive or having another severe immunodeficiency 7. Prostatitis during the past 12 months 8. Any condition which, in the opinion of the investigator, would prevent full and safe participation in this trial, or would interfere with the evaluation of the trial endpoints
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is dose-limiting toxicity between 1x10E11 and 5x10E12 Virus Particles Ad[I/PPT-E1A], defined as any irreversible grade 3 or 4 toxicity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are histopathological changes with respect to necrosis and inflammatory features, immunological changes with respect to the systemic and local innate and adaptive immune system profile, and the presence of tumour-specific and adenovirus-specific T cells in blood and the prostate before, during and after Ad[I/PPT-E1A] oncolytic adenovirus therapy. | — |
Countries
Netherlands
Outcome results
None listed