title: Visually directed high-intensity focused ultrasound for organ-confined prostate cancer: A proposed standard for the conduct of therapy.
abstract: OBJECTIVE
  To propose a standard for the conduct of visually directed transrectal high-intensity focused ultrasound (HIFU) and to offer a formal description of the changes observed on B-mode ultrasonography (US) during this procedure. We describe our early experience of using two different treatment methods; algorithm-based HIFU and visually directed HIFU for the treatment of organ-confined prostate cancer.
  
  
  METHODS
  Between November 2004 and October 2005, 34 men were treated using the Sonablate-500 (Focus Surgery, Indianapolis, IN, USA) as primary therapy for T1 or T2 prostate cancer. None had had previous hormone therapy and all had > or = 3-month PSA nadirs recorded at the follow-up. Nine men were treated using an algorithm-based protocol (group 1) and 25 using visually directed therapy (group 2). The conduct of visually directed treatment was described and changes seen using B-mode US were categorized using three 'Uchida' grades. RESULTS The mean PSA nadir achieved in group 2 was 0.15 ng/mL, vs 1.51 ng/mL in group 1 (P < 0.005). In group 2, 21 of 25 men achieved PSA nadirs of < or = 0.2 ng/mL 3 months after treatment. Seven men achieved undetectable PSA values. The occurrence rate of treatment-related toxicity was similar in both groups.
  
  
  CONCLUSIONS
  Visually directed, transrectal HIFU enables clinically important and statistically significantly lower PSA nadirs to be achieved than algorithm-based HIFU. This is the first reported experience of visually directed HIFU for the treatment of organ-confined prostate cancer. We think that this is the first attempt to standardize the conduct of therapy; such standardization facilitates teaching it, and makes it possible to derive quality standards. The standardization of the conduct of therapy is a key step in the process of health technology assessment.
authors.affiliation: The Institute of Urology and Nephrology, University College London, London, UK. rowland@doctors.org.uk
authors.forename: Rowland O
authors.initials: RO
authors.lastname: Illing
authors.forename: Tom A
authors.initials: TA
authors.lastname: Leslie
authors.forename: James E
authors.initials: JE
authors.lastname: Kennedy
authors.forename: John G
authors.initials: JG
authors.lastname: Calleary
authors.forename: Christopher W
authors.initials: CW
authors.lastname: Ogden
authors.forename: Mark
authors.initials: M
authors.lastname: Emberton
mesh_terms: D000368:Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging / Q000628:therapy*; D012015:Reference Standards; D014463:Ultrasonography; D036761:Ultrasound, High-Intensity Focused, Transrectal / Q000592:standards*
chemical_list: D017430:Prostate-Specific Antigen