Objective: To assess the long term oncologic results of high-intensity focused ultrasound therapy (HIFU) as a primary and single treatment for clinically localized prostate cancer.
Methods: A total of 119 patients with clinically localized prostate cancer underwent HIFU (Ablatherm((R)), EDAP, France) as first-line treatment and were retrospectively reviewed. They were stratified according to risk groups proposed by D'Amico. No patient had undergone previous hormonal therapy. PSA level was monitored at 3, 6, 12, 18, 24 months and then yearly. According to the latest ASTRO criteria, failure was defined by a PSA rise of 2 ng/ml or more above the PSA nadir. The biochemical-free survival rate (BFSR) was calculated.
Results: Mean patient age was 68 +/- 7.8 years (46-83). Mean follow-up was 3.9 years (1-6.8). Overall 52 patients (43.7%) experienced a biochemical recurrence which included 26, 23 and 3 patients in the low, intermediate and high-risk groups, respectively. In univariate and multivariate analyses, there was a statistical association between preoperative PSA value > 10, a nadir PSA value > 1 and the risk of biochemical recurrence (P < 0.05). The 5-year BFSR rate was 30% with no statistical difference between low- and intermediate-risk patients. None of the 119 patients died of prostate cancer.
Conclusion: High-intensity focused ultrasound therapy provides efficient oncologic control only in patients with low-risk prostate cancer. However, our data could be used to improve the selection of patients who are potential candidates for HIFU therapy.