Oncolytic adenovirus therapy as an adjuvant treatment for localised prostate cancer.
- Conditions
- Oncolytic adenovirus therapy, Localised prostate cancer, Adjuvant treatment, Radical prostatectomyOncolytische adenovirus therapie, Gelokaliseerde prostaatkanker, Adjuvante behandeling, Radicale prostatectomie
- Registration Number
- NL-OMON24928
- Lead Sponsor
- Erasmus MC
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
1. Men 35-70 years old scheduled to undergo radical prostatectomy in Erasmus MC
2. Histologically proven adenocarcinoma of the prostate
Exclusion Criteria
1. Patients with >= 20% risk on lymph node involvement according to the Memorial Sloan-Kettering Cancer Centre (MSKCC) Prostate Cancer Prediction Tool for pre-treatment risk assessment. This tool is available at http://www.mskcc.org/mskcc/html/10088.cfm
2. Prior androgen ablation hormonal therapy (except treatment with finasteride - if discontinued > 3 months prior to inclusion in current protocol)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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<br>cells in blood and the prostate before, during and after Ad[I/PPT-E1A] oncolytic adenovirus therapy.