Revolutionizing Prostate Cancer Treatment: The Landmark HIFI Study

Prostate cancer is a significant global health concern, with millions of men diagnosed each year. Traditional treatment options, such as radical prostatectomy (RP), have been the gold standard for many years. However, a groundbreaking clinical study, known as the HIFI Study, is challenging the status quo and offering hope for a less invasive, tissue-sparing treatment option: High-Intensity Focused Ultrasound (HIFU).

The HIFI Study, published in the prestigious European Urology journal, is the largest (N = 3,328) prospective, comparative, multi-center clinical study ever conducted comparing prostate cancer treatments. The study evaluated HIFU versus radical prostatectomy (RP) as a first-line treatment for localized prostate cancer. The paper, entitled "Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized, HIFI Trial," was authored by Dr. Guillaume Ploussard from the Department of Urology, UROSUD, Clinique La Croix du Sud, France.

The HIFI Study's findings are nothing short of revolutionary. Professor Pascal Rischmann, Principal Investigator of the HIFI trial and senior author of the publication, noted that the study underscores HIFU's excellent oncologic control while highlighting its significantly better functional outcomes compared to radical prostatectomy. The data from the HIFI Study not only demonstrates Focal One robotic HIFU's non-inferiority to surgery but also highlights its superior functional outcomes, particularly in urinary continence and erectile function preservation.

At 30 months, the adjusted Salvage Treatment-free Survival (STFS) was higher in the HIFU arm (90%) compared with the RP arm (86%). The propensity score-adjusted result is similar to the univariate result, with a lower risk of salvage treatment in the HIFU arm compared to RP, even in the intermediate risk subgroup. This result remains true when analyzing the subgroup with intermediate risk (HR=0.66 [95%CI, 0.50-0.86], p=0.001).

The study also showed that patients receiving HIFU had significantly less deterioration in urinary continence compared to those receiving RP. The International Continence Society (ICS) score was significantly less deteriorated for HIFU (29%) vs. RP (44%) (RR=0.66 [95%CI, 0.59-0.74], p<0.001) for all ages combined. Additionally, the International Index of Erectile Function-5 (IIEF-5), a well-validated measurement of erectile function, decreased significantly less after HIFU than after RP, with a drop in difference in medians from -9 (-10;-7.7) to -3.0 (-3.9; -2.1) between both groups, for all ages included.



The post-procedural benefits of HIFU on both erectile function and urinary continence were demonstrated despite patients in the HIFU-treated group being an average of 9.6 years older (median age was 74.7 years for HIFU vs. 65.1 years for RP, p<0.001). This suggests that HIFU is a viable treatment option for older patients seeking less invasive, tissue-sparing alternatives.

The publication of the HIFI study in European Urology will undoubtedly 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. As the single largest and most rigorous clinical study ever conducted comparing oncologic and functional outcomes between Focal One robotic HIFU and radical prostatectomy, the publication of this data highlights the substantial clinical benefits of Focal One as an important, first-line treatment option for the management of localized prostate cancer.

In conclusion, the HIFI Study's groundbreaking results challenge traditional treatment methods and offer hope for a less invasive, tissue-sparing alternative to radical prostatectomy. With its superior functional outcomes and non-inferior oncologic control, HIFU is poised to become a preferred treatment option for patients seeking to preserve sexual function and urinary continence while effectively treating their prostate cancer. As awareness of the HIFI Study's findings grows, the adoption of Focal One robotic HIFU is likely to accelerate, further advancing treatment decision guidelines and improving the lives of countless men with prostate cancer.