Methods and analysis Trial protocol Patients with confirmed prost

Methods and analysis Trial protocol Patients with confirmed prostate cancer scheduled for radical prostatectomy (RP) with a life expectancy of at least 10 years will consecutively undergo the IRE procedure approximately 30 days prior to the RP. The time frame is based on animal studies, which report completely dissolved IRE lesions after at least 3 weeks. Furthermore, it http://www.selleckchem.com/products/Cisplatin.html is in line with the Department of Health maximum allowed waiting time criteria as well as the standard time between biopsy and RP. Recruitment will take place in two academic hospitals: Academic Medical Center, Amsterdam, the Netherlands and Sismanoglio hospital, Athens, Greece. The study

is approved by the research ethics committees of both hospitals and registered in the clinicaltrials.gov database (NCT01790451). Inclusion and exclusion criteria Patients who are scheduled for a RP and meet the inclusion criteria (box 1) will be offered to attend a screening visit. The urologist together with a research nurse will explain the study protocol and the patients’ information brochure will be provided. Patients will be excluded from the study if they meet any of the exclusion criteria listed in box 2. To rule out cardiac disorders, every patient will undergo ECG. If the patient chooses

to participate, the informed consent form has to be signed accompanied by one of the research fellows. Box 1 Inclusion criteria Patients with prostate cancer who are indicated to undergo a radical prostatectomy. Life expectancy >10 years. Able to visualise prostate gland adequately on transrectal ultrasound imaging. No prostate calcification greater than 5 mm. Ability of a participant to stop anticoagulant and antiplatelet therapy for 7 days prior and 7 days postprocedure. Box 2 Exclusion criteria Bleeding disorders Active urinary tract infection History of bladder neck contracture Inflammatory bowel diseases Concurrent major debilitating illness Implantable cardioverter

defibrillator (ICD)/pacemaker/cardiac history Prior or concurrent malignancy Biological therapy for prostate cancer Chemotherapy for prostate cancer Brefeldin_A Hormonal therapy for prostate cancer within 3 months of procedure Radiotherapy for prostate cancer Transurethral prostatectomy or urethral stent Prior major rectal surgery Baseline characteristics Physical examination will be performed and validated questionnaires (IPSS, IIEF-5 and EPIC) will be used to report baseline urinary and erectile symptoms as recommended by the International Multidisciplinary Consensus on Trial Design for Focal Therapy.13 Prostate cancer-related pain is measured on the standardised VAS, ranging from 0 to 10, with higher scores indicating more severe pain.14 Postoperative pain management will be determined as well. Imaging studies Multiparametric MRI mpMRI (1.

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