title: High-intensity focused ultrasound for the treatment of prostate cancer: A prospective trial with long-term follow-up.
abstract: OBJECTIVE
  High-intensity focused ultrasound (HIFU) is a minimally invasive treatment for prostate cancer. Data from the literature show promising oncological outcomes with a favourable side-effect profile. The aim of this study was to re-evaluate and bring up to date the follow-up of a previously published, prospective trial on HIFU as the primary treatment for prostate cancer.
  
  
  METHODS
  Between 2004 and 2007, 163 consecutive men with T1-T3N0M0 prostate cancer underwent HIFU with the Sonablate 500. Follow-up included prostate-specific antigen (PSA) tests every 3 months after treatment and a random prostate biopsy at 6 months. Failure was defined according to positive findings at the 6 month biopsy and biochemical failure was defined according to the Phoenix criteria. Biochemical-free survival, metastasis-free survival and cancer-specific survival were calculated by Kaplan-Meier curves.
  
  
  RESULTS
  Median follow-up was 72.0 months. Of the 160 evaluable patients, 104 (65%) were biochemically disease free; in low- to intermediate-risk disease, on Kaplan-Meier analysis the 8 year biochemical-non-evidence of disease (bNED), metastasis-free survival and cancer-specific survival rates were 69.6%, 81.3%, 100% and 40.5%, 60.6%, 100%, respectively. A PSA nadir below 0.40 ng/ml and risk stratification have an independent predictive value for bNED and metastasis-free survival.
  
  
  CONCLUSIONS
  A long-term favourable outcome of HIFU is associated with careful patient selection, with low- to intermediate-risk disease being the ideal case. A low postoperative PSA nadir is a predictor of long-term bNED.
authors.affiliation: University of Perugia, Urology Department, Ospedale Santa Maria della Misericordia, Sant'Andrea delle Fratte , Perugia , Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Mearini
authors.forename: Leonardo
authors.initials: L
authors.lastname: D'Urso
authors.forename: Devis
authors.initials: D
authors.lastname: Collura
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Nunzi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Muto
authors.forename: Massimo
authors.initials: M
authors.lastname: Porena
mesh_terms: D000368:Aged; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D007610:Kallikreins / Q000097:blood; D053208:Kaplan-Meier Estimate; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000473:pathology*; D009367:Neoplasm Staging; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome; D036761:Ultrasound, High-Intensity Focused, Transrectal / Q000379:methods*
chemical_list: C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen
keywords: Biochemical-free survival; HIFU; cancer-specific survival; high-intensity focused ultrasound; prostate cancer