Medium-Term Outcomes after Primary Whole-Gland High-Intensity Focused Ultrasound Ablation for the Treatment of Prostate Cancer: A Single-Center Experience

<b><i>Objectives:</i></b> Our aim was to assess the oncologic and functional outcomes of primary whole-gland high-intensity focused ultrasound (WG-HIFU) treatment for non-metastatic prostate cancer (PCa). <b><i>Patients and Methods:</i></b> We retrospectively analyzed data from 227 men treated with WG-HIFU at a single center between 2011 and 2019. Patients with prostate-specific antigen (PSA) greater than 20 ng/mL, positive nodes, or missing data were excluded. Primary outcome was failure-free survival (FFS). Failure was defined as any recurrence requiring salvage radical or systemic treatment, metastasis, or PCa-specific death. <b><i>Results:</i></b> The median follow-up was of 47 months. FFS rates at 1, 3, and 5 years were 97%, 82%, and 75%, respectively. The 5-year FFS rates were 91%, 78%, and 59% for the low-, intermediate-, and high-risk patients, respectively. The 5-year metastasis-free survival and cancer-specific survival rates were 93% and 97%, respectively. The overall pad-free continence and social continence rates were 83% and 95%, respectively. Approximately 62% of previously potent patients undergoing WG-HIFU maintained erections sufficient for penetration. Bilateral nerve-sparing (NS) improved functional outcomes, with 68.6% achieving sufficient erections and 89.6% achieving pad-free continence. Clavien-Dindo grade 3 complications occurred in 22%. Higher PSA, clinical T stage, biopsy grade group, and nadir PSA levels were independently associated with treatment failure. <b><i>Conclusion:</i></b> WG-HIFU combined with transurethral resection of the prostate provides good medium-term oncologic control in appropriately selected patients and tolerable results in terms of genitourinary toxicity. Bilateral NS was associated with better urinary and erectile function.