title: Whole-gland ablation of localized prostate cancer with high-intensity focused ultrasound: oncologic outcomes and morbidity in 1002 patients.
abstract: BACKGROUND
  High-intensity focused ultrasound (HIFU) is a nonsurgical therapy for selected patients with localized prostate cancer (PCa).
  
  
  OBJECTIVE
  The long-term oncologic and morbidity outcomes of primary HIFU therapy for localized PCa were evaluated in a prospective, single-arm, single-institution cohort study.
  
  
  METHODS
  Participants were patients treated with HIFU for localized PCa from 1997 to 2009. Excluded were patients with local recurrence following radiotherapy. A second HIFU session was systematically performed in patients with biopsy-proven local recurrence.
  
  
  METHODS
  Whole-gland prostate ablation with transrectal HIFU.
  
  
  METHODS
  Incontinence was assessed using the Ingelman-Sundberg score, and potency was assessed using the five-item version of the International Index of Erectile Function (IIEF-5) scores. Primary outcomes were survival rates (biochemical-free, cancer-specific, metastasis-free, and overall survival). Secondary outcomes were morbidity rates. Median follow-up was 6.4 yr (range: 0.2-13.9). The Kaplan-Meier method was used to determine survival estimates, and multivariate analysis was used to determine predictive factors of biochemical progression.
  
  
  CONCLUSIONS
  A total of 1002 patients were included. The median nadir prostate-specific antigen (PSA) was 0.14 ng/ml, with 63% of patients reaching a nadir PSA ≤0.3 ng/ml. Sixty percent of patients received one HIFU session, 38% received two sessions, and 2% received three sessions. The 8-yr biochemical-free survival rates (Phoenix definition) were 76%, 63%, and 57% for low-, intermediate-, and high-risk patients, respectively (p < 0.001). At 10 yr, the PCa-specific survival rate and metastasis-free survival rate (MFSR) were 97% and 94%, respectively. Salvage therapies included external-beam radiation therapy (EBRT) (13.8%), EBRT plus androgen-deprivation therapy (ADT) (9.7%), and ADT alone (12.1%). Severe incontinence and bladder outlet obstruction decreased with refinement in the technology, from 6.4% and 34.9% to 3.1% and 5.9%, respectively. Limitations included the fact that the study was a single-arm study without a comparison group, technological improvements, changes in surgical protocol during the study, and the use of ADT to downsize the prostate in 39% of patients.
  
  
  CONCLUSIONS
  HIFU is a potentially effective treatment of localized PCa, with a low PCa-specific mortality rate and a high MFSR at 10 yr as well as acceptable morbidity.
authors.affiliation: Hospices Civils de Lyon, Department of Urology and Transplantation Surgery, Edouard Herriot Hospital, Lyon, France; Inserm, U1032, LabTau, Université de Lyon, Lyon, France. Electronic address: sebastien.crouzet@chu-lyon.fr.
authors.forename: Sebastien
authors.initials: S
authors.lastname: Crouzet
authors.affiliation: Inserm, U1032, LabTau, Université de Lyon, Lyon, France.
authors.forename: Jean Yves
authors.initials: JY
authors.lastname: Chapelon
authors.affiliation: Hospices Civils de Lyon, Radiology Department, Edouard Herriot Hospital, Lyon, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Rouvière
authors.affiliation: Hospices Civils de Lyon, Pathology Department, Edouard Herriot Hospital, Lyon, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Mege-Lechevallier
authors.affiliation: Hospices Civils de Lyon, Department of Urology and Transplantation Surgery, Edouard Herriot Hospital, Lyon, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Colombel
authors.affiliation: Hospices Civils de Lyon, Department of Urology and Transplantation Surgery, Edouard Herriot Hospital, Lyon, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Tonoli-Catez
authors.affiliation: Hospices Civils de Lyon, Department of Urology and Transplantation Surgery, Edouard Herriot Hospital, Lyon, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Martin
authors.affiliation: Hospices Civils de Lyon, Department of Urology and Transplantation Surgery, Edouard Herriot Hospital, Lyon, France; Inserm, U1032, LabTau, Université de Lyon, Lyon, France.
authors.forename: Albert
authors.initials: A
authors.lastname: Gelet
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use; D018572:Disease-Free Survival; D007172:Erectile Dysfunction / Q000209:etiology; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000628:therapy*; D011878:Radiotherapy; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome; D036761:Ultrasound, High-Intensity Focused, Transrectal / Q000009:adverse effects; D001748:Urinary Bladder Neck Obstruction / Q000209:etiology; D014549:Urinary Incontinence / Q000209:etiology*
chemical_list: D000726:Androgen Antagonists; D000970:Antineoplastic Agents; D017430:Prostate-Specific Antigen
keywords: Disease-free survival; High-intensity focused ultrasound ablation; Localized prostate cancer; Survival rate