title: Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial.
abstract: BACKGROUND
  Current surgical and ablative treatment options for prostate cancer (PCa) may result in a high incidence of (temporary) incontinence, erectile dysfunction and/or bowel damage. These side effects are due to procedure related effects on adjacent structures including blood vessels, bowel, urethra and/or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective and safe in destroying PCa cells and also has the potential advantage of sparing surrounding tissue and vital structures, resulting in less impaired functional outcomes and maintaining men's quality of life.
  
  
  METHODS
  In this randomized controlled trial (RCT) on IRE in localized PCa, 200 patients with organ-confined, unilateral (T1c-T2b) low- to intermediate-risk PCa (Gleason sum score 6 and 7) on transperineal template-mapping biopsies (TTMB) will be included. Patients will be randomized into focal or extended ablation of cancer foci with IRE. Oncological efficacy will be determined by multiparametric Magnetic Resonance Imaging, Contrast-Enhanced Ultrasound imaging if available, TTMP and Prostate Specific Antigen (PSA) follow-up. Patients will be evaluated up to 5 years on functional outcomes and quality of life with the use of standardized questionnaires.
  
  
  CONCLUSIONS
  There is critical need of larger, standardized RCTs evaluating long-term oncological and functional outcomes before introducing IRE and other focal therapy modalities as an accepted and safe therapeutic option for PCa. This RCT will provide important short- and long-term data and elucidates the differences between focal or extended ablation of localized, unilateral low- to intermediate-risk PCa with IRE.
  
  
  BACKGROUND
  Clinicaltrials.gov database registration number NCT01835977. The Dutch Central Committee on Research Involving Human Subjects registration number NL50791.018.14.
authors.affiliation: Department of Urology, AMC University Hospital, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. m.j.scheltema@amc.nl.
authors.forename: Matthijs J V
authors.initials: MJ
authors.lastname: Scheltema
authors.affiliation: Department of Urology, AMC University Hospital, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
authors.forename: Willemien
authors.initials: W
authors.lastname: van den Bos
authors.affiliation: Department of Urology, AMC University Hospital, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.|Department of Biomedical Engineering and Physics, AMC University Hospital, Amsterdam, The Netherlands.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: de Bruin
authors.affiliation: Department of Urology, AMC University Hospital, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.|Signal Processing Systems, Eindhoven University of Technology, Eindhoven, The Netherlands.
authors.forename: Hessel
authors.initials: H
authors.lastname: Wijkstra
authors.affiliation: Department of Urology, AMC University Hospital, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
authors.forename: M Pilar
authors.initials: MP
authors.lastname: Laguna
authors.affiliation: Department of Urology, AMC University Hospital, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
authors.forename: Theo M
authors.initials: TM
authors.lastname: de Reijke
authors.affiliation: Department of Urology, AMC University Hospital, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
authors.forename: Jean J M C H
authors.initials: JJ
authors.lastname: de la Rosette
mesh_terms: D055011:Ablation Techniques / Q000009:adverse effects / Q000379:methods*; D000328:Adult; D000368:Aged; D001706:Biopsy; D018274:Electroporation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D011467:Prostate / Q000473:pathology; D011471:Prostatic Neoplasms / Q000473:pathology / Q000628:therapy*; D016896:Treatment Outcome
keywords: Ablation; Focal therapy; IRE; Irreversible electroporation; Localized; Prostate cancer; Randomized controlled trial