Positive Treatment Outcomes Shown With Focal One Robotic HIFU

EDAP TMS SA is releasing promising study results indicating its High-Intensity Focused Ultrasound (HIFU) therapy leads to better outcomes compared with radical prostatectomy (RP) in treating localized prostate cancer.

“The HIFI study 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 Professor Pascal Rischmann, principal investigator of the HIFI trial and senior study author. “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.”

Titled, “Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized, HIFI Trial,” the study is authored by Dr. Guillaume Ploussard from Department of Urology, UROSUD, Clinique La Croix du Sud, France.

HIFI is the first prospective, multi-center, non-inferiority comparative study evaluating HIFU and RP in managing localized prostate cancer. This seven-year study (April 2015 – March 2022) enrolled 3,328 patients from 46 treatment centers: 1,967 consecutive patients were treated with EDAP’s robotic HIFU technologies, where Focal One was used for 90% of the patients, and 1,361 patients underwent radical prostatectomy surgery. All patients were followed for 30 months.

Clinical Data Highlights:

• At 30 months, the adjusted STFS was higher in the HIFU arm (90%) compared with RP arm (86%)
• The propensity score-adjusted result is similar to the univariate result (HR=0.71 [95%CI, 0.52-0.97], p=0.008). After adjustment on different variables (age, BMI, ASA score, grade group, prostate volume, PSA): the risk of salvage treatment was lower in the HIFU arm compared to RP. This result remained true when analyzing the subgroup with intermediate risk (HR=0.66 [95%CI, 0.50-0.86], p=0.001).
• International Continence Society (ICS) score, a measure of stress urinary incontinence 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.
• 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.
• 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)

“We are pleased to announce the publication of the HIFI study results in European Urology,” EDAP TMS CEO Ryan Rhodes stated. “As the single largest and most rigorous clinical study ever conducted comparing oncologic and functional outcomes between Focal One robotic HIFU and radical prostatectomy, this data highlights the substantial clinical benefits of Focal One as an important, first line treatment option for the management of localized prostate cancer. We believe the publication of such important, positive results will provide additional momentum to growing Focal One adoption, while further advancing treatment decision guidelines.”

EDAP TMS develops, manufactures, promotes, and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP TMS introduced the Focal One in Europe and the United States as a prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer.