[Results of transrectal focused ultrasound for the treatment of localized prostate cancer (120 patients with PSA < or + 10ng/ml].

OBJECTIVES To evaluate the efficacy of high intensity focused ultrasound (HIFU) for the treatment of localized prostate cancer in a population of potentially curable patients. MATERIALS AND METHODS 120 patients with clinical stage T1-T2 prostate cancer with an initial PSA < or = 10 ng/ml and not candidates for radical prostatectomy were treated by HIFU (ABLATHERM, EDAP S.A.). Clinical failure was defined by the need for adjuvant therapy (endocrine or external beam radiotherapy). Progressive disease (laboratory failure) was strictly defined by identification of residual cancer on follow-up biopsies (regardless of the PSA) or by 3 successive elevations of PSA (when follow-up biopsies were negative) with a velocity greater than 0.75 ng/ml/year. Progression-free survival rates were calculated according to the Kaplan-Meier method. Success rates stratified according to risk factors were compared by Log-rank tests. RESULTS The patients presented the following characteristics on inclusion: mean age: 71.2 +/- 5.34 years, PSA: 5.67 +/- 2.47 ng/ml, prostatic volume: 33.6 +/- 16.5 cc, stage: T1:61, T2:59, Gleason score 2-6: 77, 7-10: 43. The mean number of HIFU session per patient was 1.5 +/- 0.7. The mean duration of catheterization was 9 days and the mean follow-up was 27 months (range: 3-96 months). Follow-up biopsies did not reveal any residual cancer in 103 patients (86%). A residual cancer was identified in 17 patients, but only 6 patients required adjuvant therapy (endocrine: n = 2, radiotherapy: n = 4), corresponding to a clinical success rate of 95%. Progression-free survival for the whole patient population was 76.9%. A significant difference (p < 0.05) was observed between patients with a Gleason score between 2 and 6 (85.4%) and patients with a Gleason score between 7 and 10 (61.3%). CONCLUSION These results show that high intensity focused ultrasound is a treatment option achieving similar results to those of other non-surgical treatments for prostate cancer.