Prospective studies of more than 50 men with localised (T1-T2, N0-Nx, M0) or locally advanced (T3-T4, N0-Nx, M0) prostate cancer or who had recurrent prostate cancer after treatment failure of radical prostatectomy or external-beam radiation therapy were eligible for inclusion.
Interventions included: high-intensity focused ultrasound; Ablatherm and/or Sonablate (200, 500) compared with radical prostatectomy with/without dissection of pelvic lymph nodes; external-beam radiation therapy (with/without hormone therapy) or interstitial brachytherapy; and active surveillance/watchful waiting.
Eligible outcomes comprised: clinical efficacy (surrogate outcomes such as prostate-specific antigen (PSA) kinetics, biopsy results); patient outcomes (five-year survival, disease-free survival, overall survival, quality of life); and safety outcomes (acute/chronic urinary retention, urinary incontinence, urinary tract infection, stricture/stenosis (bladder neck/ureter), erectile dysfunction, rectourethral fistula, chronic pain) and mortality.
All included studies were uncontrolled prospective case series. Around 93% of patients underwent HIFU for primary therapy and 7% underwent salvage HIFU. Just over half (56%) of the patients who underwent HIFU for primary therapy were treated with the Ablatherm device and 44% were treated with the Sonablate device; the Ablatherm device was used for all salvage HIFU treatments.
For patients who received Ablatherm high-intensity focused ultrasound as primary therapy, mean age ranged from 66 to 72 years, mean preoperative PSA level was 7ng/mL to 12ng/mL, Gleason score was ≤7 in most patients and the mean preoperative prostate volume was 21mL to 37mL.
For patients who received salvage therapy, mean age was 67 to 71 years, mean preoperative PSA level was 8ng/mL, Gleason score was ≤8 in most patients and preoperative prostate volume was between 21mL and 35mL.
For patients who received Sonablate high-intensity focused ultrasound as primary therapy, median age ranged from 68 to 72 years, median PSA level was 5ng/mL to 10ng/ml, Gleason score was ≤7 for most patients and median preoperative prostate volume was 22mL to 33mL. No studies assessed salvage therapy. Most studies were in Germany, France and Japan; some were in Korea, UK and Italy.
Two reviewers independently assessed studies for inclusion; disagreements were resolved through consensus or consultation with a third reviewer.