Determining Optimal Patient Selection for High-intensity Focused Ultrasound for Prostate Cancer.

[BACKGROUND AND OBJECTIVE] Magnetic resonance imaging (MRI)/ultrasound-guided high-intensity focused ultrasound (HIFU) ablates prostate cancer with promising cancer control and minimal impact on sexual or urinary function. However, recurrence remains a concern. This study identifies factors associated with recurrence and treatment failure to optimize patient selection.

[METHODS] Men who underwent robotic HIFU (FocalOne) at University of California San Francisco (2021-2023) and had a 1-yr post-HIFU MRI-fusion biopsy were included. The primary outcomes were biopsy-proven in-field and overall recurrence. The secondary outcomes included treatment failure (salvage whole-gland treatment with surgery or radiation, or development of metastases) and changes in urinary/sexual function. Cox proportional hazards and multivariable logistic regression were used for an analysis.

[KEY FINDINGS AND LIMITATIONS] Among 135 men with a follow-up biopsy at 12 mo, pre-HIFU Gleason grade ≥3 (≥GG3; hazard ratio [HR] 3.11; 95% confidence interval [CI] 1.30-7.47) and a high genomic risk score (HR 2.87; 95% CI 1.18-6.99) were associated with in-field biopsy-proven recurrence. Overall biopsy-proven recurrence was linked to ≥GG3 (HR 2.62; 95% CI 1.03-6.67) and prostate-specific antigen (PSA) >10 versus <6 ng/ml (HR 5.64; 95% CI 1.82-17.48). The rates of treatment failure requiring salvage whole-gland treatment or metastasis was 4% at 1 yr and 16% overall, with a median (interquartile range) time to treatment failure of 16 (13-18) mo. Urinary and sexual function remained unchanged; no Clavien-Dindo grade >2 complications, urethral stricture, or urethra-rectal fistula were recorded.

[CONCLUSIONS AND CLINICAL IMPLICATIONS] Pre-HIFU ≥GG3 disease, a high genomic risk score, and elevated PSA correlate with local recurrence. These findings emphasize the importance of careful patient selection, as HIFU can effectively control cancer with minimal urinary or sexual side effects in suitable patients.