Adverse events and QoL assessment The device related, periprocedural and postprocedural adverse selleck Pacritinib events will be measured using the NCI Common Terminology Criteria for Adverse Events (CTCAE). CTCAE is a descriptive terminology that can be utilised for reporting adverse events. CTCAE is widely accepted throughout the oncology community as the standard classification and severity grading scale for adverse events in cancer therapy clinical trials and other oncology settings. A grading scale is provided for each adverse event term.26 QoL will be assessed by a validated comprehensive instrument (EPIC) designed to evaluate patient functioning and symptoms after prostate cancer treatment. The IPSS

urinary QoL score (0–5) will be used for with low scores demonstrating good QoL. Follow-up Patients will be dismissed 1 day after the procedure, once prostate-specific antigen (PSA) measurement, adverse event reporting and VAS scoring have been completed and when the clinical condition allows it. At 1 and 4 weeks post-IRE, the patients are physically examined. Uroflowmetry is obtained and the patient is asked to fill out each questionnaire again. Two weeks post-IRE, a consultation

is scheduled over the telephone. At one, two and 4 weeks post-IRE all symptoms and adverse events will be recorded. Biostatisticians of the CROES will complete all data analysis. In case of clear harm to the participants, defined as severe adverse events (grade 3; CTCAE V.4.0) or futility of the study, the trial will be terminated in consultation with independent interdepartmental monitors and the data safety monitoring board. An overview of participants’ timeline is added in online supplementary appendix 1. The histological examination of the prostate specimen from both participating centres will be performed at the department of pathology in the AMC, Amsterdam. It has been hypothesised that the IRE ablation zone can be defined by using the 2D ultrasound images in combination with the planning software on the IRE device. Histological

examination will include macroscopic inspection—overall appearance, size and weight. Serial whole mount sections of 3–5 mm, perpendicular GSK-3 to the urethra, are followed by a cut surface of each slice and inspected macroscopically and documented by photography. Whole mount slices from apex to base will be embedded in paraffin; 4 µm thick sections will be cut and examined with H&E staining. The boundaries of the ablation zone will be determined by light microscopy and marked on the slides, using the ultrasound imaging as a template. The volume of tissue alteration will be determined by adding the areas, as calculated using planimetrical analysis in AMIRA software (FEI Visualization Sciences Group). The outcome of the histopathological examination will be communicated to the patient at 1 or 2 weeks in follow-up.