eoadjuvant pre-radical prostatectomy gene therapy (HSV-tk gene transduction followed by Ganciclovir) in patients with poor prognostic indicators.
Completed
- Conditions
- ocalised prostate cancer
- Registration Number
- NL-OMON21955
- Brief Summary
1. van der Linden RRM, Haagmans BL, Mongiat-Artus P, van Doornum GJ, Kraaij R, Kadmon D, Aguilar-Cordova E, Osterhaus ADME, van der Kwast TH and Bangma CH. Virus specific immune responses after human neoadjuvant adenovirus-mediated suicide gene therapy for prostate cancer. European Urology 2005;48:153-61.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1. Man, 35-70 years old;
2. Histologically proven adenocarcinoma of the prostate which is clinically localized (including bone scan, not CT);
Exclusion Criteria
1. Prior androgen ablation hormonal therapy (except treatment with finasteride – If discontinued > 3 months prior to inclusion);
2. Prior surgery or other invasive treatment for BPH (i.e. TURp, hyperthermia, laser prostatectomy, etc);
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 hospitalization for surgery (day 21 till 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.