title: The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol.
abstract: BACKGROUND
  Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, which may diminish the quality of life. The side effects are a consequence of procedure-related damage of the blood vessels, bowel, urethra or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective in destroying tumour cells and harbours the advantage of sparing surrounding tissue and vital structures. The aim of the study is to evaluate the safety and efficacy and to acquire data on patient experience of minimally invasive, transperineally image-guided IRE for the focal ablation of prostate cancer.
  
  
  METHODS
  In this multicentre pilot study, 16 patients with prostate cancer who are scheduled for a radical prostatectomy will undergo an IRE procedure, approximately 30 days prior to the radical prostatectomy. Data as adverse events, side effects, functional outcomes, pain and quality of life will be collected and patients will be controlled at 1 and 2 weeks post-IRE, 1 day preprostatectomy and postprostatectomy. Prior to the IRE procedure and the radical prostatectomy, all patients will undergo a multiparametric MRI and contrast-enhanced ultrasound of the prostate. The efficacy of ablation will be determined by whole mount histopathological examination, which will be correlated with the imaging of the ablation zone.
  
  
  BACKGROUND
  The protocol is approved by the ethics committee at the coordinating centre (Academic Medical Center (AMC) Amsterdam) and by the local Institutional Review Board at the participating centres. Data will be presented at international conferences and published in peer-reviewed journals.
  
  
  CONCLUSIONS
  This pilot study will determine the safety and efficacy of IRE in the prostate. It will show the radiological and histopathological effects of IRE ablations and it will provide data to construct an accurate treatment planning tool for IRE in prostate tissue.
  
  
  BACKGROUND
  Clinicaltrials.gov database: NCT01790451.
authors.affiliation: Department of Urology, Department of Biomedical Engineering & Physics, Department of Anesthesiology, Department of Pathology, Department of Radiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: W
authors.initials: W
authors.lastname: van den Bos
authors.affiliation: Department of Urology, Department of Biomedical Engineering & Physics, Department of Anesthesiology, Department of Pathology, Department of Radiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: D M
authors.initials: DM
authors.lastname: de Bruin
authors.affiliation: Department of Urology, Department of Biomedical Engineering & Physics, Department of Anesthesiology, Department of Pathology, Department of Radiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: B G
authors.initials: BG
authors.lastname: Muller
authors.affiliation: 2nd Department of Urology, Athens Medical University, University of Athens, Athens, Greece.
authors.forename: I M
authors.initials: IM
authors.lastname: Varkarakis
authors.affiliation: 2nd Department of Urology, Athens Medical University, University of Athens, Athens, Greece.
authors.forename: A A
authors.initials: AA
authors.lastname: Karagiannis
authors.affiliation: Department of Urology, Department of Biomedical Engineering & Physics, Department of Anesthesiology, Department of Pathology, Department of Radiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: P J
authors.initials: PJ
authors.lastname: Zondervan
authors.affiliation: Department of Urology, Department of Biomedical Engineering & Physics, Department of Anesthesiology, Department of Pathology, Department of Radiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: M P
authors.initials: MP
authors.lastname: Laguna Pes
authors.affiliation: Department of Urology, Department of Biomedical Engineering & Physics, Department of Anesthesiology, Department of Pathology, Department of Radiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: D P
authors.initials: DP
authors.lastname: Veelo
authors.affiliation: Department of Urology, Department of Biomedical Engineering & Physics, Department of Anesthesiology, Department of Pathology, Department of Radiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: C D
authors.initials: CD
authors.lastname: Savci Heijink
authors.affiliation: Department of Urology, Department of Biomedical Engineering & Physics, Department of Anesthesiology, Department of Pathology, Department of Radiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: M R W
authors.initials: MRW
authors.lastname: Engelbrecht
authors.affiliation: Department of Urology, Department of Biomedical Engineering & Physics, Department of Anesthesiology, Department of Pathology, Department of Radiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.|Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Wijkstra
authors.affiliation: Department of Urology, Department of Biomedical Engineering & Physics, Department of Anesthesiology, Department of Pathology, Department of Radiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: T M
authors.initials: TM
authors.lastname: de Reijke
authors.affiliation: Department of Urology, Department of Biomedical Engineering & Physics, Department of Anesthesiology, Department of Pathology, Department of Radiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: J J M C H
authors.initials: JJMCH
authors.lastname: de la Rosette
mesh_terms: D055011:Ablation Techniques / Q000379:methods*; D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D015331:Cohort Studies; D018274:Electroporation / Q000379:methods*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology*; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000473:pathology / Q000601:surgery*
keywords: Focal therapy; Irreversible electroporation; Prostate cancer