Outcome Analysis of High-Intensity Focused Ultrasound for Clinically Localized Prostate Cancer In Japan

Purpose

We report cancer related outcomes and treatment related toxicities following HIFU therapy for men with localized prostate cancer.

Materials and Methods

This series comprises 340 patients who were treated with Sonablate® HIFU devices (Focus Surgery, IN, USA) patients with a minimum follow-up of one year. During follow-up, prostatic biopsies and PSA level measurements were performed to determine the failure as 3 consecutive rises in the PSA according to the ASTRO definition. None of the patients received androgen deprivation prior to documenting biochemical failure. Kaplan-Meier curves and log-rank test were used for analysis.

Results

The median age and PSA level were 68 years (range 45-88) and 9.5 ng/ml (range 3.1 to 154), respectively. Stage was attributed as follows: T1c in 173, T2a in 106, T2b in 47 and T3 in 14 patients. The median follow-up period for all patients was 23.2 months (range 3 to 86). The biochemical disease-free survival (bDFS) at 5 years in all patients was 70%. The bDFS at 5 years for patients with low, intermediate and high risk groups were 90%, 65% and 57%, respectively (p<0.0001). The bDFS at 5 years for patients with PSA less than 10 ng/ml, 10-20 ng/ml and more than 30 ng/ml were 88%, 68% and 17%, respectively (p<0.0001). 78% had negative biopsies from a mean of 6 cores 6 months after HIFU.

Conclusions

HIFU appears to be both an effective and well tolerated procedure for men with localized prostate cancer.