Published data show noninferior treatment-free survival with HIFU vs RP

Data from the prospective, nonrandomized HIFI trial (NCT04307056) showed that treatment with whole-gland or subtotal high-intensity focused ultrasound (HIFU) achieved noninferior salvage therapy-free survival (SFTS) outcomes and significantly lower functional impairments compared with radical prostatectomy in patients with localized prostate cancer.¹

Pascal Rischmann, MD, PhD

These data, originally presented at the 2024 American Urological Association Annual Meeting, were recently published in European Urology.

“The publication of the HIFI study in European Urology will importantly serve to increase awareness amongst the global urology and patient community on how robotic HIFU technology is rapidly changing the treatment paradigm for patients with localized, early-stage prostate cancer,” said senior author Pascal Rischmann, MD, PhD, a urologist and president of l'Académie Nationale de Chirurgie, France, in a news release on the findings.² “It is clear that a growing number of men with localized prostate cancer are seeking less invasive, tissue-sparing treatment options that will help preserve their sexual function and urinary continence. The data from the HIFI study not only underscores HIFU’s excellent oncologic control, but also highlights its significantly better functional outcomes when compared to radical prostatectomy.”

Overall, data showed that HIFU was noninferior to radical prostatectomy on the study’s primary end point of 30-month STFS (HR, 0.71; 95% CI, 0.52–0.97; P = .008). Specifically, 90% of patients in the HIFU arm vs 86% of patients in the radical prostatectomy arm were free from subsequent definitive treatment at 30 months. The results were consistent in a subgroup analysis of those with intermediate-risk disease (grade group 2; HR, 0.66; 95% CI, 0.50–0.86; P = .001).

Regarding functional outcomes, a deterioration in 12-month urinary continence was observed in 29% of patients in the HIFU cohort and 44% of patients in the surgery cohort. The HIFU arm also demonstrated a lower decrease in median International Index of Erectile Function-5 score vs the radical prostatectomy arm.

The cohorts demonstrated comparable outcomes on both the International Prostate System Score and quality-of-life measures.

Regarding safety, 23.9% of patients (471 of 1967) in the HIFU arm and 15% of patients (205 of 1361) in the surgery arm experienced an adverse event (AE). Urinary retention was the primary AE reported in the HIFU arm, observed in approximately 10% of patients. In the radical prostatectomy arm, the primary AEs were operative injuries (including urinary fistulas) and urinary retention.

Additionally, grade 3a or higher complications were reported in 2.75% of patients (54 of 1967) in the HIFU arm compared with 2.13% of patients (29 of 136) in the radical prostatectomy arm (P = 0.3). No instances of prostate cancer-specific mortality or distant metastases have been reported in either group.

In total, the prospective, noninferiority, nonrandomized study enrolled 3328 patients across 46 clinical trial sites. Of those included in the study, 1967 patients underwent HIFU, and 1361 patients underwent radical prostatectomy. Overall, 61% of patients in the HIFU cohort had intermediate-risk prostate cancer vs 64% of patients in the radical prostatectomy cohort (P = .10).

The median age in the HIFU cohort was 74.7 years, compared with 65.1 years in the radical prostatectomy cohort (P < .001). The median prostate-specific antigen level was 7.1 ng/mL in the HIFU arm and 6.9 ng/mL in the radical prostatectomy arm.

Overall, data from the trial suggest that HIFU provides comparable STFS and quality-of-life outcomes to radical prostatectomy while demonstrating a lower impact on patient-reported outcomes.

However, the authors note, “These results should be interpreted with caution owing to the lack of randomization and the age difference between the groups. Future research should consider longer follow-up and evaluate focal treatments.”

References

1. Ploussard G, Coloby P, Chevallier T, et al. Whole-gland or subtotal high-intensity focused ultrasound versus radical prostatectomy: The prospective, noninferiority, nonrandomized HIFI trial. Eur Urol. 2024 Dec:S0302-2838(24)02701-5. doi:10.1016/j.eururo.2024.11.006

2. Landmark HIFI study publication demonstrates positive outcomes with Focal One Robotic HIFU versus surgery in the management of prostate cancer. News release. EDAP TMS S.A. December 4, 2024. Accessed December 10, 2024. https://www.globenewswire.com/news-release/2024/12/04/2991603/9622/en/Landmark-HIFI-Study-Publication-Demonstrates-Positive-Outcomes-with-Focal-One-Robotic-HIFU-Versus-Surgery-in-the-Management-of-Prostate-Cancer.html