Focal irreversible electroporation as primary treatment for localized prostate cancer

To determine the safety, quality of life (QoL) and short-term oncological outcomes of primary focal IRE for the treatment of localized prostate cancer. To identify potential risk factors for oncological failure. Patients that met both the consensus guidelines on patient criteria and selection methods for primary focal therapy were eligible for analysis. Focal IRE was performed for organ-confined clinically significant PCa, being high-volume Gleason sum score 6 (ISUP grade 1) or any Gleason sum score 7 (ISUP grade 2-3). Oncologic, adverse event and QoL outcome data with a minimum of 6 months follow-up were analysed. Patient characteristics and peri-operative treatment parameters were compared for patients with and without oncological failure on follow-up biopsy. Wilcoxon's Signed Rank Test, Wilcoxon's Rank Sum Test and Chi-square test were used to assess statistically significant differences in paired continuous, unpaired continuous and categorical variables respectively. A total of 63 patients met all eligibility criteria and were included for final analysis. No high-grade adverse events occurred. Quality of life questionnaire analysis demonstrated no significant change in physical (p=0.81), mental (p=0.48), bowel (p=0.25) and both urinary QoL domains (p=0.41 and p=0.25); there was a mild decrease in the sexual QoL domain (median score 66 at baseline vs 54 at 6 months, p=0.0003). Compared to baseline PSA, a decline of 70% (1.8, IQR 0.96-4.8) was seen between 6-12 months. A narrow safety margin (p=0.047) and system errors (p=0.010) were identified as potential early risk factors for in-field oncological failure. In-field and whole-gland oncological control on follow-up biopsies was 84% (38/45) and 76% (34/45); this increased to 97% (38/39) and 87% (34/39) when patients treated with a narrow safety margin and system errors were excluded. Our data supports the safety and feasibility of focal IRE as a primary treatment for localized PCa with effective short-term oncological control in carefully selected men. This article is protected by copyright. All rights reserved