ABSTRACT
BACKGROUND: To evaluate the survival and quality of life (QoL) outcomes of high-intensity focused ultrasound (HIFU) whole-gland ablation for localized prostate cancer. METHODS: Over 8 years, men with localized prostate cancer treated with whole-gland HIFU were prospectively followed. Transrectal prostate ablation was performed under general anesthesia with Sonablate-500® (Sonacare Medical©, Charlotte, North Carolina, USA). The primary outcome was failure-free survival defined as no transition to any of the following: (1) local salvage therapy (surgery or radiotherapy), (2) systemic therapy, (3) metastases, or (4) prostate cancer-specific mortality. Secondary outcomes included both survival outcomes and QoL measures. RESULTS: Of 70 men, 29.7% had International Society of Urological Pathology (ISUP) grade 1, 43.8% ISUP 2, 10.9% ISUP 3, and 15.6% ISUP 4 disease. At median follow-up of 83.4 months, overall mortality was 8.6% and prostate cancer-specific mortality 0%. Failure-free survival was 78.2% at 5 years and 71.2% at 7 years. Of all men, 7.1% of men developed metastases, with median metastasis-free survival of 75.4 months. There was negligible post-HIFU urinary incontinence or lower urinary tract symptom with a median Male Urogenital Distress Inventory score of 32 at 6 months and 33 at 12 months and median IPSS of 4 at 6 months and 3 at 12 months. Median Radiation Therapy Oncology Group rectal toxicity score was 0 throughout. In men who had mild or no erectile dysfunction at baseline (International Index of Erectile Function ≥17), the mean International Index of Erectile Function score declined to 37% from 23.5 at baseline to 14.7 at 12 months. CONCLUSION: At median follow-up of 7 years, whole-gland HIFU appears to have comparable survival outcomes with other cohort studies involving radical prostatectomy and radiotherapy patient. It has low impact on QoL, preserved urinary continence, and erectile function approximate to nerve-sparing prostatectomy. Whole-gland HIFU presents a potential alternative minimally invasive and safe option for the treatment of localized prostate cancer.
