Prospective Evaluation of Focal High-Intensity Focused Ultrasound (HIFU) for Patients with Localized Prostate Cancer.

PURPOSE: We report short-term outcomes of focal high-intensity focused ultrasound use for primary treatment of localized prostate cancer. MATERIALS AND METHODS: Single-center prospectively collected prostate cancer patients who underwent primary focal HIFU from January 2016 to July 2018 were included. All patients underwent a 12-core biopsy with MRI-US fusion biopsy depending on the presence of targetable lesions. Any Grade Group was allowed; however, only patients with localized disease were included. The primary outcome was oncologic control, defined as negative follow-up infield biopsy of treated cancer. PSA, SHIM, IPSS and EPIC domain scores were assessed 3-monthly till 12 months. Biopsy was performed at 6 or 12 months for high- or low/intermediate-risk cancer, respectively. RESULTS: Fifty-two patients with minimum follow-up of 12 months were included in the study. Majority (67%) of patients had cancer Grade Group 2 or greater. Fifteen patients (28.8%) underwent complete TURP/HoLEP procedure for debulking large prostates to avoid postoperative urinary retention. Among 30 (58%) patients who underwent follow-up biopsies, 25 (83%) had negative infield biopsy results. 4 (13%) had de-novo positive outfield biopsy. Only 5 major complications (all Grade III) in 4 patients were noted. Urinary symptoms returned to near baseline questionnaire scores within 3-6 months. Sexual function returned to baseline at 12 months. CONCLUSIONS: Focal HIFU is a safe and effective treatment for patients with localized clinically significant prostate cancer with acceptable short-term oncological and functional outcomes. The complications are minimal and patient selection is essential. Short-term oncological outcomes are promising but longer follow-up is required to establish long-term oncologic outcomes.