HIFU for Prostate Cancer: A Minimally Invasive Treatment Option Gains Reimbursement in France
For many men, a prostate cancer diagnosis is a frightening experience. In France, nearly 60,000 latest cases are diagnosed each year, making it the third leading cause of cancer death in men, affecting one in six over the age of 60. While early detection leads to a cure rate approaching 92%, concerns about side effects like incontinence and impotence often cause hesitation in seeking treatment. As of January 1, 2026, a French alternative, High Intensity Focused Ultrasound (HIFU), is now reimbursed by Social Security, offering a promising way to limit these after-effects for thousands of men.
What is HIFU?
HIFU treatment utilizes a robotic device, Focal One developed by EDAP TMS. The procedure involves inserting a probe into the rectum to identify the tumor using ultrasound, sometimes combined with MRI. Energy is then focused on the tumor area, raising the temperature to around 80°C (176°F) to destroy cancer cells without the need for incisions or radiation. Typically, the procedure lasts 30 to 90 minutes, performed under general or loco-regional anesthesia and requires only a short hospital stay.
HIFU vs. Traditional Treatments
Historically, radical prostatectomy (surgery) or radiotherapy have been the standard treatments for intermediate-grade localized prostate cancer. Although, these treatments can lead to urinary problems in 20-40% of cases and sexual dysfunction in 30-90% of patients, with potential damage to the bladder or intestine following radiotherapy. HIFU represents a form of “therapeutic de-escalation,” targeting the tumor while minimizing harm to healthy tissue. Specialists estimate that around 30% of patients – nearly 20,000 men per year – could be eligible for this treatment.
The HIFI Study: Promising Results
The HIFI study, conducted over seven years in 46 French centers, compared HIFU Focal One to total prostatectomy in 3,328 patients with localized prostate cancer. The study included 1,967 patients treated with HIFU and 1,361 treated with surgery. At 30 months, the rate of survival without the need for salvage treatment was 90% with HIFU compared to 86% with surgery, demonstrating comparable effectiveness. The research likewise indicated better preservation of urinary continence and erectile function in men treated with ultrasound.
Reimbursement and Eligibility
Based on the HIFI study’s findings, the French Health Insurance has approved reimbursement for HIFU treatment for localized cancers. This provides patients with a new, less invasive therapeutic option. Benefits of HIFU include a single treatment session, adaptability to the tumor’s size and location, and reduced toxicity compared to initial radiotherapy in cases requiring salvage treatment.
HIFU is best suited for adults with localized prostate cancer, most often of intermediate risk, that is well-defined through imaging and biopsies. It can also be considered as a secondary treatment option in cases of local recurrence after external radiotherapy. Treatment decisions are made collaboratively by a multidisciplinary team including a urologist, medical oncologist, and radiotherapist. To qualify for reimbursed HIFU treatment, centers must have an authorized oncology urology department and perform at least 20 HIFU procedures annually as a first-line treatment, or 5 as a salvage procedure.
What to Expect During and After HIFU
Patients undergoing HIFU treatment will have a short hospital stay, receive general or loco-regional anesthesia with deep sedation, and have the procedure performed by a urologist controlling the Focal One platform in real-time. A urinary catheter may be used for a few days, but recovery and return to normal activities are typically rapid. Urologists report that urinary leakage and erectile problems are less frequent after HIFU compared to radical surgery, although these risks are not entirely eliminated. Ongoing monitoring includes PSA measurements and regular imaging to assess treatment response and adjust the strategy if necessary.