The ablation zones will be precisely demarcated and 3D reconstructed using AMIRA software. Subsequently, histopathology imaging has to be assessed to determine the accurateness of ablation zone detection by mpMRI and CEUS and in order to design a valid preplanning model for IRE in prostate cancer. Sample size and data analysis plan The sample size of 16 patients is based on comparable studies with similar study design. http://www.selleckchem.com/products/BAY-73-4506.html Beerlage et al27 performed a phase II study with high-intensity focused ultrasound with a sample size of 20

followed by a published case series of 14 patients. The other studies using radiofrequency (n=14), transurethral ultrasound therapy (n=8) and cryotherapy (n=7) reported similar patient numbers.28–30 Brausi et al was among the first presenting results of an IRE pilot safety study in 11 patients with low-risk prostate cancer. No major complications occurred during the procedure. The hospital stay was 1 day for all patients. Follow-up was done at 14, 30, 90 and 180 days and 19 months with physical examination,

PSA, IPSS and IIEF. The mean IPSS reduced from 9.5 to 7.7, 7, 6.1, 4.28 and 4, respectively, and the mean IIEF went from 16.2 to 13.2, 10.5, 10.5, 11 and 17.3. During follow-up, one patient presented with an acute urinary retention and three had transient urge incontinence. Mean PSA was 3.5, 2.9, 3.3 and 3.12 ng/mL after 30, 90, 180 days and 19 months, respectively. Prostate biopsies of the ablated area were performed after 1 month with a mean of 25 (range 15–41) biopsies. Pathological report was negative in 8 of the 11 patients (73%) and showed coagulative necrosis, granulomatosis, fibrosis and haemosiderosis. Three patients had a persistent adenocarcinoma. Therefore, one patient underwent RP and two were retreated with IRE.31

Patients will be assigned with a research code on consecutive order as they enter the study. During the study, no information that can be related to the patient is shown on study material. Outcomes The primary outcome is safety as measured by the composite of procedural device and postprocedural adverse events, measured with CTCAE, EPIC-score, IPSS or required catheterisation time and IIEF and efficacy of ablation determined Carfilzomib by histological examination postprostatectomy. Secondary outcomes will be patients’ procedure satisfaction measured by patient satisfaction questions (included in EPIC score), postprocedural pain management and VAS pain score, time to ambulation, length of hospital stay. Device and procedure The AngioDynamics Inc HVP-01 Electroporation System (also registered as the NanoKnife IRE System, figure 1) consists of three components: a Low Energy Direct Current generator, needle electrodes and Accusync ECG trigger (Accusync, Milford, Connecticut, USA). Figure 1 Low Energy Direct Current Electroporation System (NanoKnife IRE System, AngioDynamics). The trigger was used to supply the pulses at a cardiac autosynchronous rate to decrease the risk of cardiac arrhythmias.