HIFU treatment is a non-invasive procedure. The urologist inserts a probe into the rectum, through the anus, to send high-intensity ultrasound directly to the tumor. Ultrasound is focused through the wall of the rectum towards the area to be treated. They heat and destroy cancer cells, while sparing surrounding healthy tissue.
The HIFI study, carried out under the aegis of the French Association of Urology, prospectively evaluates the effectiveness of treatment by robotic surgical navigation HIFU Focal One® in comparison to conventional surgery, which remains the reference treatment for localized prostate cancers. The study took place between 2015 and 2019.
If HIFU technology has existed for several years, the HIFI study provides a decisive element for its adoption in clinical practice.
HIFI, a study that brings high intensity ultrasound into practice
The HIFI study is the largest multicenter prospective and comparative clinical study conducted to date to evaluate treatments for localized prostate cancer. Thanks to the learned society of urology in particular, the French Association of Urology, it included 3,328 patients in 46 centers, divided between two groups: 1,967 patients were treated by high intensity focused ultrasound (HIFU) and 1 361 by total prostatectomy.
The main objective of the study, to demonstrate the non-inferiority of HIFU compared to total prostatectomy in terms of survival (without salvage treatment) at 30 months, was achieved. In other words, 90% of patients treated by HIFU avoided definitive treatment, and 86% by prostatectomy.
After adjustment for different variables (age, body mass index, various oncological scores, prostate volume, PSA level, etc.), the risk of salvage treatment (when the cancer continues to progress after a first treatment) is lower in the HIFU arm compared to the total prostatectomy arm
Better preserved urinary and sexual function
The results of the HIFI study show significant benefits of HIFU treatment on urinary continence and erectile function compared to radical prostatectomy. In detail, the ICS (International Continence Society) score, which assesses the total absence of urinary leakage, is better with HIFU (29% compared to 44% for total prostatectomy), regardless of the age of the patients.
For erectile function, the IIEF-5 index (International Index of Erectile Function-5) shows a less marked decrease after HIFU treatment compared to a greater decrease after prostatectomy.
The treatment in fact protects anatomical structures such as the urinary sphincter, located just under the prostate, and the erectile nerves, which run along the organ.
In terms of quality of life, the scores measured by the QLCQ-30 questionnaire are comparable between the two groups. Note, these benefits of HIFU are observed despite the higher median age of patients treated by this method (74.7 years compared to 65.1 years for total prostatectomy).
A new treatment in the arsenal of urologists
Although this trial has some methodological limitations, including the lack of randomization (patients were not randomly allocated between the total prostatectomy group and the HIFU group) and the age difference between the groups (difference in ‘median age of almost 10 years), it marks a turning point in medical practices. This change is validated by the oncology committee of the French Urology Association and the French health authorities.
“HIFU robotic technology, now out of its experimental phase, is now changing the paradigm for the management of localized prostate cancer at an early stage,” commented Professor Pascal Rischmann, principal investigator of the HIFU, at the press conference. HIFI study and senior author of its publication. The results of the HIFI study, involving carefully selected patients, confirm not only the oncological effectiveness (the positive effect on the tumor, editor’s note) of HIFU technology, but also functional results superior to those of surgery, even robot-assisted, with the same indications. »
Additional studies, over longer periods (beyond 30 months), will be able to better evaluate the impact of the treatment in real conditions, on patient survival as well as on its functional consequences.
More than sixty centers in France can offer this technique.
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Source: Destination Santé
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