Multicentric oncologic outcomes of high-intensity focused ultrasound for localized prostate cancer in 803 patients.

BACKGROUND High-intensity focused ultrasound (HIFU) is an emerging treatment for select patients with localized prostate cancer (PCa). OBJECTIVES To report the oncologic outcome of HIFU as a primary care option for localized prostate cancer from a multicenter database. DESIGN, SETTING, AND PARTICIPANTS Patients with localized PCa treated with curative intent and presenting at least a 2-yr follow-up from February 1993 were considered in this study. Previously irradiated patients were excluded from this analysis. In case of any residual or recurrent PCa, patients were systematically offered a second session. Kaplan-Meier analysis was performed to determine disease-free survival rates (DFSR). MEASUREMENTS Prostate-specific antigen (PSA), clinical stage, and pathologic results were measured pre- and post-HIFU. RESULTS AND LIMITATIONS A total of 803 patients from six urologic departments met the inclusion criteria. Stratification according to d'Amico's risk group was low, intermediate, and high in 40.2%, 46.3%, and 13.5% of patients, respectively. Mean follow-up was 42+/-33 mo. Mean PSA nadir was 1.0+/-2.8 ng/ml with 54.3% reaching a nadir of < or =0.3 ng/ml. Control biopsies were negative in 85% of cases. The overall and cancer-specific survival rates at 8 yr were 89% and 99%, respectively. The metastasis-free survival rate at 8 yr was 97%. Initial PSA value and Gleason score value significantly influence the DFSR. The 5- and 7-yr biochemical-free survival rates (Phoenix criteria) were 83-75%, 72-63%, and 68-62% (p=0.03) and the additional treatment-free survival rates were 84-79%, 68-61%, and 52-54% (p<0.001) for low-, intermediate-, and high-risk patients, respectively. PSA nadir was a major predictive factor for HIFU success: negative biopsies, stable PSA, and no additional therapy. CONCLUSIONS Local control and DFSR achieved with HIFU were similar to those expected with conformal external-beam radiation therapy (EBRT). The excellent cancer-specific survival rate is also explained by the possibility to repeat HIFU and use salvage EBRT.