title: Nanoknife Electroporation Ablation Trial: A Prospective Development Study Investigating Focal Irreversible Electroporation for Localized Prostate Cancer.
abstract: Irreversible electroporation has attractive attributes for focal ablation, namely nonthermal effect, precise demarcation of treatment and tissue selectivity. We report a prospective development study investigating focal irreversible electroporation.
  
  
  
  A total of 20 men with certain characteristics were recruited for study, including a visible index lesion on anterior magnetic resonance imaging that was concordant with transperineal targeted and template prostate mapping biopsy, absent clinically significant disease noted elsewhere (University College London definition 2) and prostate specific antigen 15 ng/ml or less. Our primary objective was to determine the side effect profile at 12 months. Secondary objectives included the domain specific toxicity profile using patient reported outcomes and early disease control using magnetic resonance imaging targeted biopsy.
  
  
  
  A total of 19 patients with median age of 60 years (IQR 53-66) and median prostate specific antigen 7.75 ng/ml (IQR 5.5-10.03) were treated. Of the patients 16 were available for estimating the first outcome as 1 was lost to followup and 2 had received another form of treatment by study end. All 16 men had pad-free/leak-free continence at 12 months. The proportion of men with erection sufficient for penetration decreased from 12 of 16 (75%) to 11 of 16 (69%). No serious adverse events were recorded. There was a statistically significant improvement in urinary symptoms according to changes in UCLA-EPIC (UCLA Expanded Prostate Cancer Index Composite) and I-PSS (International Prostate Symptom Score) (p = 0.039 and 0.001, respectively). Erectile function remained stable according to the change in IIEF-15 (15-Item International Index of Erectile Function) (p = 0.572). Median prostate specific antigen significantly decreased to 1.71 ng/ml (p = 0.001). One man refused followup biopsy. No residual disease was found in 11 patients (61.1%). One man (5.6%) harbored clinically insignificant disease and the remaining 6 (33.3%) harbored clinically significant disease.
  
  
  
  Focal irreversible electroporation has low genitourinary toxicity. Additional studies are needed to optimize patient selection and treatment parameters.
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, University College London Hospitals National Health Service Foundation Trust, London, United Kingdom; Department of Urology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. Electronic address: massimo.valerio.12@ucl.ac.uk.
authors.forename: Massimo
authors.initials: M
authors.lastname: Valerio
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, University College London Hospitals National Health Service Foundation Trust, London, United Kingdom.
authors.forename: Louise
authors.initials: L
authors.lastname: Dickinson
authors.affiliation: Department of Mental Health Sciences, University College London, London, United Kingdom.
authors.forename: Afia
authors.initials: A
authors.lastname: Ali
authors.affiliation: Department of Radiology, University College London Hospitals National Health Service Foundation Trust, London, United Kingdom.
authors.forename: Navin
authors.initials: N
authors.lastname: Ramachadran
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, University College London Hospitals National Health Service Foundation Trust, London, United Kingdom.
authors.forename: Ian
authors.initials: I
authors.lastname: Donaldson
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, University College London Hospitals National Health Service Foundation Trust, London, United Kingdom.
authors.forename: Neil
authors.initials: N
authors.lastname: Mccartan
authors.affiliation: Department of Histopathology, University College London Hospitals National Health Service Foundation Trust, London, United Kingdom.
authors.forename: Alex
authors.initials: A
authors.lastname: Freeman
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, University College London Hospitals National Health Service Foundation Trust, London, United Kingdom.
authors.forename: Hashim U
authors.initials: HU
authors.lastname: Ahmed
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, University College London Hospitals National Health Service Foundation Trust, London, United Kingdom.
authors.forename: Mark
authors.initials: M
authors.lastname: Emberton
mesh_terms: D055011:Ablation Techniques; D000368:Aged; D018274:Electroporation; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011446:Prospective Studies; D017430:Prostate-Specific Antigen; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*
chemical_list: D017430:Prostate-Specific Antigen
keywords: biomedical; electroporation; prostatic neoplasms; questionnaires; technology assessment; toxicity