Key Points
- Results from a large multicenter study directly comparing focused ultrasound with radical prostatectomy surgery were recently published.
- Two and a half years after treatment, focused ultrasound had similar disease control scores with less incontinence and impotence.
Results from the first large, multicenter prospective study (NCT04307056) directly comparing high-intensity focused ultrasound (HIFU) with radical prostatectomy surgery for the treatment of localized prostate cancer were recently published in the journal European Urology.
“This landmark study is a significant milestone for the focused ultrasound community,” said Hugo Embert, vice president of marketing and reimbursement at Focal One. “The investigators concluded that when compared with surgery, HIFU provides comparable cancer control and better preservation of continence and erectile function.
The non-inferiority study, which evaluated more than 3,300 patients treated in 46 centers in France from 2015–2019, compared four various measures of survival plus functional outcomes (e.g., urinary incontinence, erectile dysfunction) among patients undergoing EDAP’s Focal One Robotic HIFU versus the standard-of-care radical prostatectomy as a first line treatment for prostate cancer.
With a primary endpoint of salvage therapy–free survival (STFS), the study found that HIFU was not inferior to surgery after a medium-term follow-up of 30 months. Furthermore, the rate of complications was comparable. In terms of quality of life after treatment, Internal Prostate Symptom Scores and quality-of-life scores were also comparable between the two groups, but the HIFU group reported less impairment from urinary incontinence and erectile dysfunction.
In the Focal One press release, Professor Pascal Rischmann, MD, PhD, the principal investigator of the study, stated that these findings will “serve to increase awareness amongst the global urology community on how robotic HIFU technology is rapidly changing the treatment paradigm for patients with localized, early-stage prostate cancer.”
Study limitations included a lack of randomization and a significant age difference between the groups (median age of 74.7 years in the HIFU group versus 65.1 years in the surgery group). The median prostate-specific antigen PSA (level) was slightly higher in the HIFU group (7.1 versus 6.9 ng/ml).
“The Foundation applauds the investigators on this important comparative study, which is the first to directly compare HIFU, a noninvasive therapy, with an invasive surgery in a head-to-head approach,” said Tim Meakem, MD, one of the Foundation’s managing directors and co-director of the Research and Education Team. “The equal results in terms of cancer control suggest that HIFU should be part of the decision tree for patients with prostate cancer. The added bonus for those choosing HIFU is a much lower risk of the unwanted prostatectomy side effects: incontinence and impotence.”
Read the Focal One Press Release
Visit the Study Website
See media coverage from OncLive, as reported from the 2024 American Urological Association’s Annual Meeting, the Urology Times, MedPage Today, Targeted Oncology, BioSpace, Imaging Technology News, and others.
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