EDAP TMS S.A. announced a recent presentation highlighting the positive, final results from a large, prospective, multicenter, non-inferiority study, the HIFI Study, comparing Focal One® high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) at the 119thAmerican Urological Association Annual Meeting (AUA 2024), which took place from May 3-6, 2024, in San Antonio, Texas, USA. Professor Pascal Rischmann of Rangueil University Hospital in Toulouse, France, and lead investigator of the HIFI Study, highlighted the final results from the study during an oral presentation at the AUA plenary session, ?Paradigm-shifting, Practice-changing Clinical Trials in Urology?. HIFI is the first prospective, multi-center, investigator-sponsored study comparing robotic HIFU to RP in the management of prostate cancer.

The study, which ran from April 2015 through March 2022, compared Focal One HIFU versus RP as a first line treatment for patients with localized prostate cancer (grade groups <3). A total of 3,328 patients from 46 treatment centers were included: 1,967 consecutive patients were treated with EDAP?s robotic HIFU technologies, where Focal One was used for 90% of the patients. 1,361 patients underwent radical prostatectomy surgery.

All patients were followed for 30 months. Select data highlights: At 30 months, the STFS was higher in the HIFU arm (89.6%) compared with RP arm (86.2%). The propensity score-adjusted result is similar to the univariate result (HR=0.75 [0.55-1.03], p=0.076).

After adjustment on different variables (Age, BMI, ASA score, Grade Group, prostate volume, PSA) the results are similar to the univariate analysis: the risk of salvage treatment is lower in the HIFU arm compared to RP. International Continence Society (ICS) score, a measure of urinary incontinence, was significantly lower after HIFU for 3 of the 4 questions. Urinary Symptom Profile (USP) showed a significantly lower stress incontinence score for patients after HIFU than RP (0 vs 1, p?

International Index of Erectile Function-5 (IIEF-5), a well validated measurement of erectile function, decreased significantly less after HIFU than after RP in patients 69 and older with a score of 15 or higher at baseline (median ? = -8 vs -13 p?