title: High intensity focused ultrasound with Focal-One®device: Prostate-specific antigen impact and morbidity evaluation during the initial experience.
abstract: OBJECTIVE
  We report our initial experience in the treatment of prostate cancer (PCa) with high-intensity focused ultrasound (HIFU) using the Focal-One®device.
  
  
  METHODS
  Retrospective review of the prospectively populated database. Between June 2014 to October 2015, 85 patients underwent HIFU (focal/whole-gland) treatment for localized PCa. Preoperative cancer localization was done with multiparametric magnetic resonance imaging (mpMRI) and transperineal mapping biopsies. Treatment was carried out using the Focal-One®device under general anesthesia. Oncological follow-up: PSA measurement and control biopsy with mpMRI according to protocol. Questionnaire-based functional outcome assessment was done. Complications were reported using Clavien classification.
  
  
  RESULTS
  The median PSA was 7.79ng/ml (IQR 6.32-9.16), with a median prostate volume of 38cc (IQR: 33-49.75). Focal and whole-gland therapy was performed in 64 and 21 patients respectively. Ten patients received salvage HIFU. Complications were encountered in 15% of cases, all Clavien 2 graded. Mean hospital stay was 1.8 days (0-7) and bladder catheter was removed on day 2 (1-6). Mean percentage reduction of PSA was 54%. Median follow-up was 3 months (IQR: 2-8). Functional outcomes: All patients were continents at 3 months and potency was maintained in 83% of the preoperatively potent.
  
  
  CONCLUSIONS
  Focal-One®HIFU treatment appears to be a safe procedure with few complications. Functional outcomes proved no urinary incontinence and sexual function were maintained in 83%.
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: J I
authors.initials: JI
authors.lastname: Perez-Reggeti
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia. Electronic address: rafael.sanchez-salas@imm.fr.
authors.forename: R
authors.initials: R
authors.lastname: Sanchez-Salas
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: A
authors.initials: A
authors.lastname: Sivaraman
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: E
authors.initials: E
authors.lastname: Linares Espinos
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: A E
authors.initials: AE
authors.lastname: de Gracia-Nieto
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: E
authors.initials: E
authors.lastname: Barret
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: M
authors.initials: M
authors.lastname: Galiano
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: F
authors.initials: F
authors.lastname: Rozet
authors.affiliation: Departamento de Radiología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: A
authors.initials: A
authors.lastname: Fregeville
authors.affiliation: Departamento de Radiología, Pitié-Salpêtrière Hospital, París, Francia.
authors.forename: R
authors.initials: R
authors.lastname: Renard-Penna
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: N
authors.initials: N
authors.lastname: Cathala
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: A
authors.initials: A
authors.lastname: Mombet
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: D
authors.initials: D
authors.lastname: Prapotnich
authors.affiliation: Departamento de Urología, Institut Mutualiste Montsouris, París, Francia.
authors.forename: X
authors.initials: X
authors.lastname: Cathelineau
mesh_terms: D000368:Aged; D057086:High-Intensity Focused Ultrasound Ablation / Q000295:instrumentation*; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology; D017430:Prostate-Specific Antigen / Q000097:blood*; D011468:Prostatectomy / Q000295:instrumentation* / Q000379:methods; D011471:Prostatic Neoplasms / Q000097:blood* / Q000601:surgery*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D017430:Prostate-Specific Antigen
keywords: Cáncer de próstata; Focal therapy; Hemiablación; Hemiablation; High-intensity focused ultrasound; Prostate cancer; Terapia focal; Ultrasonido focalizado de alta intensidad