title: Complete high-intensity focused ultrasound in prostate cancer:  outcome from the @-Registry.
abstract: BACKGROUND
  To analyze data on patients with localized prostate cancer who were treated with complete high-intensity focused ultrasound (HIFU) prospectively captured within a voluntary HIFU user database (@-Registry).
  
  
  METHODS
  The @-Registry includes data from consecutive patients treated with Ablatherm (EDAP-TMS) HIFU at nine European Centres during the period 1994 and 2009. For this analysis, the data repository was reviewed for information on patients with localized prostate cancer (T1 -- T2) treated with complete (whole-gland) HIFU on the basis of an anterior-posterior prostate height of ≤24 mm and a treated volume >120% of the prostate volume. Patients were regularly followed with PSA measurement and biopsy. Biochemical failure was defined for this study as PSA nadir +2 ngml(-1) (Phoenix definition). Disease-free survival was based on a biopsy, retreatment and biochemical data. Patients were risk group-stratified using the D'Amico classification system.
  
  
  RESULTS
  The median follow-up was 2.8 years for the 356 patients included in the analysis. The majority could be classified as either low (44.9%) or intermediate risk (39.6%); 14.6% patients were classified as high risk. The median (mean, s.d.) PSA nadir was 0.11 ng ml(-1) (0.78 and 3.6), achieved at a mean (s.d.) of 14.4 (11.6) weeks after HIFU. Follow-up biopsies on 226/356 (63.5%) patients revealed an overall negative biopsy rate of 80.5% (182/226); there was no statistically significant difference in positive biopsy rate by risk group-stratification. Actuarial freedom from biochemical recurrence at 5 and 7 years according to the Phoenix definition was 85% and 79%, respectively. Disease-free progression rates at 5 and 7 years were 64% and 54%, respectively.
  
  
  CONCLUSIONS
  Whole-gland prostate HIFU as primary monotherapy for localized prostate cancer achieves a recurrence-free survival in short-term analysis as assessed by prostate biopsy and serum PSA endpoints in a majority of patients.
authors.affiliation: Department of Urology, Fuerth Hospital, Fuerth, Germany. andreas.blana@klinikum-fuerth.de
authors.forename: A
authors.initials: A
authors.lastname: Blana
authors.forename: C N
authors.initials: CN
authors.lastname: Robertson
authors.forename: S C W
authors.initials: SC
authors.lastname: Brown
authors.forename: C
authors.initials: C
authors.lastname: Chaussy
authors.forename: S
authors.initials: S
authors.lastname: Crouzet
authors.forename: A
authors.initials: A
authors.lastname: Gelet
authors.forename: G N
authors.initials: GN
authors.lastname: Conti
authors.forename: R
authors.initials: R
authors.lastname: Ganzer
authors.forename: G
authors.initials: G
authors.lastname: Pasticier
authors.forename: S
authors.initials: S
authors.lastname: Thuroff
authors.forename: J F
authors.initials: JF
authors.lastname: Ward
mesh_terms: D000368:Aged; D057086:High-Intensity Focused Ultrasound Ablation; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D012042:Registries; D016019:Survival Analysis; D016896:Treatment Outcome