EDAP TMS announces final results from HIFI study of Focal One HIFU

EDAP TMS announced a recent presentation highlighting the final results from a large, prospective, multicenter, non-inferiority study, the HIFI Study, comparing Focal One high intensity focused ultrasound versus radical prostatectomy at the 119th American Urological Association Annual Meeting, 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. 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 compared with RP arm; The propensity score-adjusted result is similar to the univariate result. After adjustment on different variables 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 score, a measure of urinary incontinence, was significantly lower after HIFU for 3 of the 4 questions; Urinary Symptom Profile showed a significantly lower stress incontinence score for patients after HIFU than RP; International Index of Erectile Function-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; 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. “The final results from the HIFI Study clearly demonstrate that treatment with robotic HIFU for the management of localized prostate cancer is at least as effective as radical prostatectomy, but with added potential for improved safety outcomes with respect to urinary continence and sexual function,” said Professor Pascal Rischmann. “It is increasingly evident that the application of robotic HIFU has growing relevance in the management of localized disease, and these final results from the HIFI Study provide conclusive evidence in support of this technology as a safe, effective, and less invasive approach to remove cancerous tissue from the prostate.”