EDAP TMS SA has announced a recent presentation of positive results from a large, multicenter, non-inferiority study comparing Focal One high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) at the 38th Annual Congress of the European Association of Urology (EAU), which was held March 10-13, in Milan, Italy.
The study, which ran from April 2015 through September 2019, 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 42 treatment centers were included: 1,967 were treated with Focal One HIFU and 1,361 underwent radical prostatectomy surgery. Patients were followed for 30 months.
Select data highlights:
- At 30 months, the STFS was higher in the HIFU arm (90.1%) compared with RP arm (86.8%);
- Risk of salvage treatment was greater than 1.2-fold higher after RP (HR: 0.75, 95% CI [0.64-0.96], p = 0.02);
- ICS score, a measure of urinary incontinence, was significantly lower after HIFU (0 vs 1, p < 0.001);
- IIEF-5, a measure of erectile function, decreased significantly less after HIFU than after RP despite (median Δ = -4 vs -9 p < 0.001);
- 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>0.0001);
- After HIFU, median PSA nadir was 0.34 ng/ml and positive biopsy rate was 12.5%; after RP, median PSA was 0.01 ng/ml and positive margins (PM) were reported in 26% of RP-treated patients.
Professor Pascal Rischmann of Rangueil University Hospital in Toulouse, France, and lead investigator of the study, commented, “I was very pleased to present, for the first time, the final consolidated results from this major academic study which was sponsored by the French Association of Urology. This is the largest study ever done to prospectively evaluate HIFU against radical prostatectomy. The aim of this post-approval, non-inferiority study was to compare the survival rates without salvage treatment in both arms, as well as to confirm reimbursement of HIFU in France. These results confirm the growing importance of HIFU in the management of localized prostate cancer.”
Marc Oczachowski, Chairman and Chief Executive Officer of EDAP TMS, added, “The positive results from this very large study add to the significant and growing body of evidence demonstrating not only the efficacy of HIFU, but also the superior side effect profile which can meaningfully impact patients’ quality of life. With a growing recognition of the clinical benefits of HIFU treatment, EDAP continues to expand global access to Focal One HIFU so that more prostate cancer patients have the opportunity to realize the treatment benefits of our therapeutic HIFU technology.”