Objectives:To assess the long-term outcomes of transrectal high-intensity focused ultrasound (HIFU) for patients with localized prostate cancer. Methods: From May 2003 to present, 137 consecutive patients with T1-2 prostate cancer were treated using the Sonablate 500 and then followed for more than 12 months after their last HIFU treatment. A prostate biopsy was routinely carried out at 6 months and serum prostate-specific antigen (PSA) was measured every 3 months after HIFU. Oncological outcomes as well as treatment-related complications were assessed. Disease-free survival (DFS) was judged using the Phoenix definition (PSA nadir + 2 ng/mL), negative histological findings and no local or distant metastasis.
Results:The median follow up after HIFU was 36 months (range 12-84 months). No patients received adjuvant therapy during this period. The PSA nadir occurred at 2 months after HIFU and the median level was 0.07 ng/mL (0.01-2.01 ng/mL). Of the 133 patients who underwent prostate biopsy or transurethral resection of the prostate at 6 months or later after HIFU, six were positive for cancer cells (4.5%). There were no major postoperative complications, but urge incontinence (16 cases) and dysuria (33 cases) occurred after removal of the urethral catheter. The 5-year DFS rate was 78% based on these criteria, and 91%, 81% and 62% in the low-, intermediate-and high-risk group, respectively. Conclusions: HIFU represents an effective, repeatable and minimally invasive treatment. It is particularly effective for low-and intermediate-risk patients, and it should be considered as an option for localized prostate cancer.