eoadjuvant pre-radical prostatectomy gene therapy (HSV-tk gene transduction followed by Ganciclovir) in patients with poor prognostic indicators

Erasmus Medical Centre (Netherlands)0 个研究点目标入组 12 人开始时间: 2005年12月20日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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

发起方

Erasmus Medical Centre (Netherlands)