title: Transrectal high-intensity focused ultrasound for treatment of patients with stage T1b-2n0m0 localized prostate cancer: a preliminary report.
abstract: OBJECTIVE
  To present our preliminary clinical results of transrectal high-intensity focused ultrasound (HIFU) in Stage T1b-2N0M0 prostate cancer. Efforts are being made to provide minimally invasive alternative treatment options with equal efficacy and fewer side effects. HIFU delivers ultrasound energy with rapid thermal necrosis of tissue in the focal region without damaging the surrounding tissue.
  
  
  METHODS
  We performed 28 HIFU treatments in 20 patients with biopsy-proven localized prostate cancer using a modified Sonablate-200 HIFU device. All patient characteristics and the clinical outcome of 20 patients followed up more than 6 months (mean 13.5) were analyzed.
  
  
  RESULTS
  A complete response was obtained in 100% (20 of 20) of patients, as evidenced by a negative postoperative prostate biopsy and no elevation on three successive prostate-specific antigen (PSA) determinations. Of the 20 patients, 13 (65%), 5 (25%), and 2 (10%) had PSA nadirs of less than 0.50 ng/mL, 0.50 to 1.00 ng/mL, and 1.01 to 2.00 ng/mL, respectively. Rectourethral fistula and urethral stricture were noted in 1 and 2 patients, respectively, and 1 patient underwent transurethral resection of the prostate because of prolonged urinary retention.
  
  
  CONCLUSIONS
  Our results show that HIFU can be performed without an incision, with a less severe side effect profile, and, unlike most other prostate treatments, is repeatable. Transrectal HIFU may be a useful option for patients with localized prostate cancer. Its long-term efficacy will be determined by additional follow-up and a Phase II trial.
authors.affiliation: Department of Urology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Toyoaki
authors.initials: T
authors.lastname: Uchida
authors.forename: Narendra T
authors.initials: NT
authors.lastname: Sanghvi
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Gardner
authors.forename: Michael O
authors.initials: MO
authors.lastname: Koch
authors.forename: Daisuke
authors.initials: D
authors.lastname: Ishii
authors.forename: Sadanori
authors.initials: S
authors.lastname: Minei
authors.forename: Takefumi
authors.initials: T
authors.lastname: Satoh
authors.forename: Toru
authors.initials: T
authors.lastname: Hyodo
authors.forename: Akira
authors.initials: A
authors.lastname: Irie
authors.forename: Shiro
authors.initials: S
authors.lastname: Baba
mesh_terms: D000368:Aged; D001706:Biopsy; D005500:Follow-Up Studies; D006801:Humans; D007902:Length of Stay; D008297:Male; D009367:Neoplasm Staging; D011471:Prostatic Neoplasms / Q000473:pathology / Q000628:therapy*; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000379:methods*