Oncolytic adenovirus therapy as an adjuvant treatment for localised prostate cancer. - Oncolytic adenovirus therapy in PCa

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•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

•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

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