Noninferiority study comparing outcomes of Focal One HIFU vs radical prostatectomy yields positive results


EDAP TMS, a global leader in robotic energy-based therapies, has announced a recent presentation of positive results from a large, multicentre, noninferiority study comparing Focal One high-intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) at the 38th annual congress of the European Association of Urology (10–13 March, Milan, Italy).

The study, which ran from April 2015 to September 2019, compared Focal One HIFU versus RP as a first-line treatment for patients with localised prostate cancer (grade groups <3). A total of 3,328 patients from 42 treatment centres were included: 1,967 were treated with Focal One HIFU and 1,361 underwent radical prostatectomy surgery. Patients were followed for 30 months.

Among the data that the study produced were the following points:

  • At 30 months, the salvage treatment-free survival rate 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);
  • Postprocedural benefits of HIFU for 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).

Pascal Rischmann (Rangueil University Hospital, Toulouse, France), who is 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 postapproval, noninferiority 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 localised prostate cancer.”


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