eoadjuvant pre-radical prostatectomy gene therapy (HSV-tk gene transduction followed by Ganciclovir) in patients with poor prognostic indicators
- Conditions
- Prostate cancerCancer
- Registration Number
- ISRCTN21565532
- Lead Sponsor
- Erasmus Medical Centre (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 12
1. Men, 35 - 70 years old
2. Histologically proven adenocarcinoma of the prostate which is clinically localised (including bone scan, not Computed Tomography [CT])
3. Prostate Specific Antigen (PSA) greater than 4 ng/ml
4. Medically fit
5. Scheduled to undergo radical prostatectomy
6. Neutrophils = 2 x 10^9/l, platelets = 100 x 10^9/l, bilirubin less than 40 ng/l, Aspartate Aminotransferase (ASAT) less than 4 x normal, Haemoglobin (Hb) = 6.5 mmol/l, Creatinine less than 150 ng/l, Partial Thromboplastin Time (PTT) and Prothrombin Time (PT)
7. Living within one hour travel distance of the hospital
8. Written consent for gene therapy after appropriate information
1. Prior androgen ablation hormonal therapy (except treatment with finasteride if discontinued greater than 3 months prior to inclusion)
2. Prior surgery or other invasive treatment for Benign Prostatic Hyperplasia (BPH) (i.e. Transurethral Resection of the Prostate [TURP], hyperthermia, laser prostatectomy etc.)
3. Patients on corticosteroids
4. Concurrent treatment with immunosuppessive drugs (Imuran, cyclophosphamide etc.)
5. Uncontrolled infections (defined as viral, bacterial of fungal infections requiring specific therapy)
6. Human Immunodeficiency Virus (HIV) positive patients
7. Immunocompromised patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the safety and toxicity of adenovirus-mediated thymidine kinase gene therapy for the neoadjuvant treatment of prostate cancer. This is established by patient monitoring from day 0 to day 14, during hospitalisation for surgery (day 21 - 28), and subsequently during routine follow-up at weeks 6 and 12, months 6, 9 and 12 and every 6 months thereafter. For this purpose, PSA, blood count, serum hepatic enzumes and creatinine measurements are performed according to routine clinical procedures. A clinical follow-up of one year will be used for safety and toxicity analysis.
- Secondary Outcome Measures
Name Time Method To study and characterize the biological effects of and the immune response induced by adenovirus-mediated thymidine kinase gene therapy.