Scientific data from the HIFI study confirm that HIFU provides results comparable to surgery, with limited functional impact.(1)
HIFU treatment results
Non-inferiority of HIFU treatment compared with surgery
In 2024, a published French trial (1) including more than 3300 patients enrolled at 46 sites proved the non-inferiority of HIFU treatment compared with standard surgery, in terms of oncological results at 30 months. It also showed favorable functional results at 12 months. More information is available on the hifistudy.com site.
Other trials have shown comparable results, highlighting the potential of HIFU to offer a strategic, therapeutic alternative. These trials also show the positive effects on the preservation of quality of life in patients treated by HIFU.
(1) Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized HIFI Trial. Guillaume Ploussardet al. – November 6, 2024 European Urology (10.1016/j.eururo.2024.11.006).
What are the potential side effects ?
Depending on the volume treated, a lack of urinary continence and/or erectile function is possible in certain cases.
The risks of urethro-rectal fistulas remain exceptional (≤ 0.8% in first-line treatment; ≤ 1.8% in post-radiotherapy)(2) and curable.
After HIFU due to radiotherapy failure, the risk of side effects is higher than in patients treated with HIFU as first-line therapy, particularly for urinary continence. This is mainly due to the urinary sphincter, which is sometimes already weakened by the radiation and older age. Partial treatment of prostates in localized recurrence after radiotherapy has also yielded better results, with fewer side effects and preserved quality of life.
After HIFU due to radiotherapy failure, the risk of side effects is higher than in patients treated with HIFU as first-line therapy, particularly for urinary continence. This is mainly due to the urinary sphincter, which
is sometimes already weakened by the radiation and older age.
Partial treatment of prostates in localized recurrence after radiotherapy has also yielded better results with fewer side effects and preserved quality of life.
(2) For more information, consult your doctor.
LEGAL NOTICE – INS-491G – 2022/04/28 – 394 804 447 RCS Lyon
Focal One is manufactured by EDAP TMS. This medical device is a regulated health care product, which bears CE marking in accordance with this regulation. Focal One is intended to use high-intensity focused ultrasound introduced via the rectum to destroy localized prostate adenocarcinoma. You must consult with your urologist.