Study offers insights into optimal patient selection for HIFU in prostate cancer

Data published in European Urology Focus shed light on factors associated with recurrence following high-intensity focused ultrasound (HIFU) for prostate cancer.¹ These data point to the importance of careful patient selection for HIFU, as the therapy was shown to be an effective and tolerable treatment option for patients with intermediate-risk localized prostate cancer.¹

"Focal therapies such as HIFU are an exciting and rapidly evolving option for localized prostate cancer, offering meaningful cancer control while preserving urinary and sexual function," said lead author Kevin Shee, MD PhD, a PGY6 resident at the University of California, San Francisco (UCSF), in correspondence with Urology Times®. "However, our findings highlight that HIFU is not a one-size-fits-all solution—its success depends on careful patient selection based on PSA, Gleason grade, and genomic risk. Tailoring treatment to the right patient is essential to achieving optimal outcomes."

For the study, the investigators conducted a retrospective review of 135 men who underwent a HIFU procedure at UCSF between 2021 to 2023. All patients had a 1-year post-HIFU MRI-fusion biopsy. The median age of patients at diagnosis was 66 years (IQR, 59 to 71).

According to biopsy data collected at a median of 12 months of follow-up, 54% of patients experience a recurrence of grade group 2 or higher disease, and 41% of patients had an in-field recurrence.

Multivariable logistic regression showed that overall recurrence was associated with GG3 or higher disease (HR, 2.62; 95% CI, 1.03 to 6.67) and a prostate-specific antigen (PSA) level of greater than 10 vs less than 6 ng/mL (HR, 5.64; 95% CI, 1.82 to 17.48). Further, in-field recurrence was associated with GG3 or higher disease (HR, 3.11; 95% CI, 1.30 to 7.47) and a high vs low/intermediate genomic risk score (HR, 2.87; 95% CI, 1.18 to 6.99).

The authors also added, “Notably, we found no significant differences in biopsy outcomes between cases treated early at our institution and later, showing no identifiable learning curve with the FocalOne device.”

Data also showed no association between the location of treatment and disease recurrence, in line with prior literature.

In total, 4 patients (3%) in the study underwent a repeat HIFU procedure. At 1 year, the rate of treatment failure, defined as progression to salvage-whole gland therapy or the development of metastasis, was 4%. The overall treatment failure rate was 16%, and the median time to treatment failure was 16 months (IQR, 13 to 18).

The investigators also compared SHIM and International Prostate Symptom Scores (IPSS) before and at 1 year following HIFU. Notably, they found no significant difference between pre- and post-HIFU SHIM scores or IPSSs. Specifically, the median SHIM score was 16 (IQR, 3 to 24) before HIFU and 13 (IQR, 3 to 21) following the procedure. The median IPSS was 6 (IQR, 3 to 12) before HIFU and 6 (IQR, 4 to 10) following the procedure.

There were also no reported instances of Clavien-Dindo greater than 2 complications or the development of rectal fistulae or urinary strictures following HIFU during the study duration.

According to the authors, these findings support the viability of HIFU in patients with intermediate risk localized prostate cancer. Significantly, they found no impact on urinary or sexual function at 1 year following treatment, which is a key advantage of focal therapy over whole-gland therapy, they explained.

However, the authors caution that a key limitation of the study is generalizability, as the data were collected from a single institution in a homogenous cohort.

They write, “Longer follow-up is needed to determine its impact on local progression and metastasis, highlighting the importance of patient selection, especially in those with a high genomic risk, high PSA, or GG3+ disease.”

REFERENCE

1. Shee K, Pace WA, Liu AW, et al. Determining optimal patient selection for high-intensity focused ultrasound for prostate cancer. Eur Urol Focus. 2025 Aug 2:S2405-4569(25)00174-9. doi:10.1016/j.euf.2025.06.007