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OBJECTIVES. To evaluate the efficacy and safety of transrectal high-intensity focused ultrasound (HIFU) as salvage therapy for locally recurrent prostate cancer after external beam radiotherapy or recurrences located in the region of vesicourethral anastomosis after radical prostatectomy. METHODS. Transrectal biopsy of the prostate (recurrence after radiotherapy) or in the region of vesicourethral anastomosis (recurrence after prostatectomy) was performed in all cases at the time of biochemical relapse. Only patients with positive biopsy were treated. Systemic disease was excluded by PET-CT and bone scan. All treatments were carried out under spinal anesthesia. The device used was Ablatherm (EDAP, Lion, France). The patients were followed with PSA measurement every 3 months and clinical examination every 6 months. In case of biochemical relapse we performed re-biopsy. RESULTS. From 2002 to 2008 we treated 19 patients with local recurrence after radiotherapy. The mean follow-up was 30 months for each patient (range 6-72 months). 9 patients (47%) are disease-free at last followup, with PSA < 1 ng/mL. 9 patients experienced biochemical failure: 8 were treated with androgen deprivation, 1 with salvage prostatectomy. 2 patients died of the disease. Adverse events related to HIFU included 1 rectourethral fistula (observed before the use of specific parameters dedicated to this patient population) and mild incontinence (2-3 pads/die) in 4 patients. From 2002 to 2008 we treated 27 patients with a local recurrence after radical prostatectomy. Mean pre-HIFU PSA was 2.17 ng/mL (range 0.5-8 ng/ml); the Gleason score ranged from 5 to 8. All patients reached a minimum follow-up of 20 months (range 20-80 months). Median PSA nadir was 0.2 ng/ml. The disease-free rate was 51% (14/27); these patients have a median PSA of 0.2 ng/ml at last follow-up. 81% (22/27) of control biopsies were negative. There were no intra-operative or post-operative complications. CONCLUSIONS. The small number of patients in our series limits our ability to draw any definitive conclusions. We believe that HIFU may be a potentially useful treatment option for patients who develop prostate cancer recurrence after external beam radiotherapy or in the region of vesicourethral anastomosis after radical prostatectomy. The procedure is safe, side effects are acceptable and do not add significant morbidity to the previous radical treatment. HIFU lesions are targeted only to the area of recurrence. It is important to remember that, in case of failure, the patient can undertake any other therapies.

[Prostate cancer: transrectal high-intensity focused ultrasound for the treatment of local recurrence after radical prostatectomy or radiotherapy].