title: Initial assessment of safety and clinical feasibility of irreversible electroporation in the focal treatment of prostate cancer.
abstract: BACKGROUND
  To evaluate the safety and clinical feasibility of focal irreversible electroporation (IRE) of the prostate.
  
  
  METHODS
  We assessed the toxicity profile and functional outcomes of consecutive patients undergoing focal IRE for localised prostate cancer in two centres. Eligibility was assessed by multi-parametric magnetic resonance imaging (mpMRI) and targeted and/or template biopsy. IRE was delivered under transrectal ultrasound guidance with two to six electrodes positioned transperineally within the cancer lesion. Complications were recorded and scored accordingly to the NCI Common Terminology Criteria for Adverse Events; the functional outcome was physician reported in all patients with at least 6 months follow-up. A contrast-enhanced MRI 1 week after the procedure was carried out to assess treatment effect with a further mpMRI at 6 months to rule out evidence of residual visible cancer.
  
  
  RESULTS
  Overall, 34 patients with a mean age of 65 years (s.d. = ± 6) and a median PSA of 6.1 ng ml(-1) (interquartile range (IQR) = 4.3-7.7) were included. Nine (26%), 24 (71%) and 1 (3%) men had low, intermediate and high risk disease, respectively (D'Amico criteria). After a median follow-up of 6 months (range 1-24), 12 grade 1 and 10 grade 2 complications occurred. No patient had grade >/= 3 complication. From a functional point of view, 100% (24/24) patients were continent and potency was preserved in 95% (19/20) men potent before treatment. The volume of ablation was a median 12 ml (IQR = 5.6-14.5 ml) with the median PSA after 6 months of 3.4 ng ml(-1) (IQR = 1.9-4.8 ng ml(-1)). MpMRI showed suspicious residual disease in six patients, of whom four (17%) underwent another form of local treatment.
  
  
  CONCLUSIONS
  Focal IRE has a low toxicity profile with encouraging genito-urinary functional outcomes. Further prospective development studies are needed to confirm the functional outcomes and to explore the oncological potential.
authors.affiliation: 1] Division of Surgery and Interventional Science, University College London, London, UK [2] Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK [3] Department of Urology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Valerio
authors.affiliation: Department of Urology, St. Vincent's Prostate Cancer Centre, Sydney, New South Wales, Australia.
authors.forename: P D
authors.initials: PD
authors.lastname: Stricker
authors.affiliation: 1] Division of Surgery and Interventional Science, University College London, London, UK [2] Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.
authors.forename: H U
authors.initials: HU
authors.lastname: Ahmed
authors.affiliation: 1] Division of Surgery and Interventional Science, University College London, London, UK [2] Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.
authors.forename: L
authors.initials: L
authors.lastname: Dickinson
authors.affiliation: 1] Department of Urology, St. Vincent's Prostate Cancer Centre, Sydney, New South Wales, Australia [2] Urology Institute, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
authors.forename: L
authors.initials: L
authors.lastname: Ponsky
authors.affiliation: Department of Radiology, St. Vincent's Prostate Cancer Centre, Sydney, New South Wales, Australia.
authors.forename: R
authors.initials: R
authors.lastname: Shnier
authors.affiliation: Department of Radiology, University College London Hospitals NHS Foundation Trust, London, UK.
authors.forename: C
authors.initials: C
authors.lastname: Allen
authors.affiliation: 1] Division of Surgery and Interventional Science, University College London, London, UK [2] Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.
authors.forename: M
authors.initials: M
authors.lastname: Emberton
mesh_terms: D000368:Aged; D053672:Electrochemotherapy / Q000009:adverse effects* / Q000379:methods*; D005240:Feasibility Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000473:pathology / Q000628:therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome