A Whole of Population, Multiuser Series of High-Intensity Focused Ultrasound for Management of Localized Prostate Cancer: Outcomes and Implications

Purpose: To determine the oncologic and complication outcomes of treatment of patients with localized prostate cancer by high intensity focused ultrasound (HIFU) for primary management of prostate cancer in a whole of population, multiuser series. Patients and Methods: We created a centralized database - accessible only by nonurologist researchers - within a cancer epidemiology center, after ethics approval from that institution. A single researcher prospectively entered baseline, treatment, and clinical/biochemical follow-up data from all patients treated with HIFU in the state of Victoria over the study period. Results: We accrued 108 patients, of whom 103 had been staged as having clinically localized disease. Ninety-three patients (86.1%) had low- or intermediate-risk prostate cancer. Forty-four patients (40.5%) had persistent mild urinary incontinence at 3 months after treatment, and 3 of these ultimately underwent further surgical procedures to correct incontinence. Twenty-seven patients (25%) additionally experienced occasions of urinary retention in the first 3 months after treatment because of passage of tissue. Twenty-nine patients had achieved a prostate-specific antigen level of <0.2 ng/mL at 3 months after HIFU. Fifty-six patients underwent post-HIFU prostate biopsy, and this was positive for residual cancer in 51 cases. Forty-five of the patients who had a positive post-HIFU biopsy underwent secondary treatment for prostate cancer. Conclusion: Oncologic control and complication outcomes in this cohort were inferior to those previously reported for HIFU in single-user series. Given the population-based multiuser nature of our series, we believe our observations are more likely to reflect the community outcomes that might be expected from widespread adoption of HIFU than generalizing from single-operator series.