The Safety and Efficacy of Irreversible Electroporation for the Ablation of Prostate Cancer Assessed by Procedural Related Side Effects and Post Prostatectomy Histology: A Prospective Human In-Vivo Study - IRE-Prostate

Academisch Medisch Centrum0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Life expectancy > 10 years
•2. Histologically confirmed organ-confined prostate cancer (clinical stage T1-T2)
•3. Gleason score *7
•4. PSA <20 ng/ml
•5. Able to visualize prostate gland adequately on transrectal US imaging
•6. No prostate calcification greater than 5 mm
•7. Ability of subject to stop anticoagulant and anti-platelet therapy for 7 days prior and 7 days post procedure

•1. Other Conditions/Status:
•a) Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/uL
•b) Active urinary tract infection (UTI)
•c) History of bladder neck contracture
•d) Anaesthesia Surgical Assignment, category IV
•e) History of inflammatory bowel disease
•f) Concurrent major debilitating illness
•g) Prior or concurrent malignancy
•h) Cardiac History
•i) ICD / Pacemaker
•2. Prior or current therapies
•a) Biologic therapy for prostate cancer
•b) Chemotherapy for prostate cancer
•c) Hormonal therapy for prostate cancer within 3 months of procedure
•d) Radiotherapy for prostate cancer
•e) Transurethral prostatectomy (*TURP*), urethral stent
•f) Prior major rectal surgery (except haemorrhoids)
•g) Inability or unwillingness to tolerate temporary cessation of concurrent anticoagulation therapy or anti-platelet drugs for a period of 7days prior to procedure and up to 7 days after procedure

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