Nearly 60,000 men in France are diagnosed with prostate cancer each year, affecting almost one in six men after the age of 60. We see the third leading cause of cancer death among men. A significant advancement taking effect January 1, 2026, is the availability of high-intensity focused ultrasound (HIFU) treatment to all eligible patients, now covered by national health insurance.
This innovative approach combines advanced imaging technologies with high-performance HIFU. It’s a conservative treatment aimed at curing the disease by precisely targeting the tumor.
What are the benefits of this technology?
The robotic HIFU technology is implemented by Focal One, a medical device developed by the French company EDAP TMS. The ultrasound is delivered non-surgically, requiring no incisions or radiation. This treatment is personalized, tailored to the shape of each patient’s tumor and prostate, whereas preserving healthy tissue and minimizing the risk of side effects. High-intensity focused ultrasound offers a way to avoid radical treatment for cancers that are still localized, all while maintaining patients’ quality of life.
A study in 2024 validated the treatment after 10 years of research, confirming its effectiveness in controlling cancer with results superior to those of surgery. “This reimbursement will allow patients to access a new, less invasive, and conservative treatment option in the management of localized prostate cancer,” explains Professor Pascal Rischmann, principal investigator of the HIFI study and senior author of the publication. Other advantages of HIFU treatment include a single session, customization based on the affected area and volume, and the preservation of options for further treatment if needed. It also demonstrates lower toxicity compared to initial radiotherapy when follow-up treatment is required.
According to Dr. Antoine Faix, president of the French Association of Urology (AFU), “urinary and sexual consequences, often feared by our patients, are significantly reduced.”
Why is this referred to as therapeutic de-escalation?
The current classification of prostate cancer includes 5 grades, from 1 to 5, in order of increasing severity. At grade 1, tumors are monitored through active surveillance. These tumors progress in 30 to 40% of cases. If progression occurs to higher grades, radical treatments such as prostatectomy or radiotherapy are used.
“These treatments are sometimes excessive and have potential side effects: urinary (20-40%), sexual (30-90%) depending on age and circumstances, as well as more specific post-radiotherapy lesions (bladder, intestine in 10-15% of cases, secondary tumors in 5-10% of cases) with, for affected patients, a deterioration in quality of life,” it is explained. Now, instead of radical treatments with potentially debilitating side effects, patients can first benefit from HIFU when the tumor worsens, adding a new tool to the arsenal of urologists-oncologists for localized tumors.
How does it work in practice?
In simple terms, energy is delivered via a probe capable of both locating the tumor using ultrasound and delivering therapeutic high-intensity focused ultrasound (HIFU). This uses concentrated acoustic waves, remarkably powerful, to destroy prostate tissue. By focusing the energy on a very precise area – the diseased area – a combination of physical phenomena occurs: mechanical destruction of cells by the waves, raising the temperature to 80°C (tumor cells burn), and coagulation of micro-vessels, which ultimately die.
Cavitation (the formation of pockets and gas bubbles) forms under the effect of ultrasound. These bubbles grow and eventually implode, contributing to the destruction of surrounding tissues and enhancing the action of ultrasound and heat.
