title: A prospective development study investigating focal irreversible electroporation in men with localised prostate cancer: Nanoknife Electroporation Ablation Trial (NEAT).
abstract: BACKGROUND
  Focal therapy may reduce the toxicity of current radical treatments while maintaining the oncological benefit. Irreversible electroporation (IRE) has been proposed to be tissue selective and so might have favourable characteristics compared to the currently used prostate ablative technologies. The aim of this trial is to determine the adverse events, genito-urinary side effects and early histological outcomes of focal IRE in men with localised prostate cancer.
  
  
  METHODS
  This is a single centre prospective development (stage 2a) study following the IDEAL recommendations for evaluating new surgical procedures. Twenty men who have MRI-visible disease localised in the anterior part of the prostate will be recruited. The sample size permits a precision estimate around key functional outcomes. Inclusion criteria include PSA ≤ 15 ng/ml, Gleason score ≤ 4 + 3, stage T2N0M0 and absence of clinically significant disease outside the treatment area. Treatment delivery will be changed in an adaptive iterative manner so as to allow optimisation of the IRE protocol. After focal IRE, men will be followed during 12 months using validated patient reported outcome measures (IPSS, IIEF-15, UCLA-EPIC, EQ-5D, FACT-P, MAX-PC). Early disease control will be evaluated by mpMRI and targeted transperineal biopsy of the treated area at 6 months.
  
  
  CONCLUSIONS
  The NEAT trial will assess the early functional and disease control outcome of focal IRE using an adaptive design. Our protocol can provide guidance for designing an adaptive trial to assess new surgical technologies in the challenging landscape of health technology assessment in prostate cancer treatment.
authors: Division of Surgery and Interventional Science, University College London, London, UK; Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK; Department of Urology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. Electronic address: massimo.valerio.12@ucl.ac.uk.
authors: Massimo
authors: M
authors: Valerio
authors: Division of Surgery and Interventional Science, University College London, London, UK; Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.
authors: Louise
authors: L
authors: Dickinson
authors: Department of Mental Health Sciences, University College London, London, UK.
authors: Afia
authors: A
authors: Ali
authors: Department of Radiology, University College London Hospitals NHS Foundation Trust, London, UK.
authors: Navin
authors: N
authors: Ramachandran
authors: Division of Surgery and Interventional Science, University College London, London, UK; Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.
authors: Ian
authors: I
authors: Donaldson
authors: Department of Histopathology, University College London Hospitals NHS Foundation Trust, London, UK.
authors: Alex
authors: A
authors: Freeman
authors: Division of Surgery and Interventional Science, University College London, London, UK; Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.
authors: Hashim U
authors: HU
authors: Ahmed
authors: Division of Surgery and Interventional Science, University College London, London, UK; Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.
authors: Mark
authors: M
authors: Emberton
mesh_terms: D055011:Ablation Techniques / Q000379:methods*; D053672:Electrochemotherapy / Q000379:methods*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D017430:Prostate-Specific Antigen; D011471:Prostatic Neoplasms / Q000628:therapy*; D012107:Research Design
chemical_list: D017430:Prostate-Specific Antigen
keywords: Focal therapy; Health technology assessment; Irreversible electroporation; Prostate cancer