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2026-03-09

Prostate cancer: focused ultrasound redefines the balance between oncologic control and functional preservation

Oncology

By Elodie Vaz | Published on March 9, 2026 | 3 min read


With nearly 60,000 new cases each year in France, prostate cancer is the most common cancer in men and the third leading cause of cancer-related mortality. One in six men over the age of 60 is affected. Although the prognosis of localized disease is often favorable, treatment remains associated, from the patient’s perspective, with feared functional sequelae. Up to 90% of patients report concerns about complications such as urinary incontinence and erectile dysfunction after treatment.

Conventional strategies—radical prostatectomy or radiotherapy—have demonstrated oncological efficacy but at the cost of non-negligible adverse effects: urinary disorders (20–40%), sexual dysfunction (30–90% depending on age), and, in the case of irradiation, certain digestive complications. In this context, the emergence of focal therapies represents a paradigm shift.


Treat the tumor, not the entire prostate


Since January 1, 2026, high-intensity focused ultrasound (HIFU) treatment using the Focal One platform developed by EDAP TMS has been reimbursed by the French national health insurance system for localized prostate cancer. The scientific and clinical objective is clear: treat the index tumor while preserving healthy prostate parenchyma in order to reduce functional morbidity. “We no longer operate with a scalpel but with a computer mouse,” explains Prof. Pascal Rischmann, former President of the French Association of Urology and of the National Academy of Surgery. “It is a personalized treatment tailored to the tumor,” he adds.

The aim of the HIFI study, published in December 2024 in European Urology, was to compare for the first time the oncologic efficacy and functional outcomes of this focal strategy with those of radical surgery.



Fewer side effects


The technology relies on individualized planning combining 3D imaging and MRI–biopsy fusion, enabling millimetric targeting of the lesion. A probe inserted through a natural orifice delivers 400 to 600 focused ultrasound pulses. At the focal point, temperatures reach 80–100 °C, inducing instantaneous tumor necrosis without incision or irradiation. The procedure is performed in a single session lasting from 30 minutes to two hours.

The HIFI study included more than 3,300 patients treated in 46 centers and directly compares focal HIFU with total prostatectomy in comparable indications.


Therapeutic de-escalation


The results “confirm not only the oncologic efficacy of HIFU technology but also superior functional outcomes compared with surgery, even robot-assisted surgery, for the same indications,” states Dr. Guillaume Ploussard, first author of the study. Functionally, the findings are particularly notable. “Patients treated with focused ultrasound maintain identical sexual function in 90% of cases,” notes Prof. Rischmann. The risk of incontinence appears significantly reduced compared with radical approaches.

Clinical testimonies illustrate these quantitative data. Hervé, 59, treated in 2023 for a recurrence, reports: “This targeted treatment is impressive! (…) After the procedure, I had very little sick leave, no pain, and no side effects.”

Constantin, an anesthesiologist, also reports: “Compared with surgery, it is an incomparable intervention—it’s incredible! (…) I experienced no functional side effects (incontinence or erectile dysfunction), which is very important for a 48-year-old man.” He concludes: “It’s revolutionary and clearly surpasses surgery at an early stage of the lesion.”

For Dr. Antoine Faix, “this new treatment represents therapeutic de-escalation, because it is a curative treatment targeting the tumor rather than a radical treatment targeting the entire prostate.” Approximately 30% of patients—nearly 20,000 men per year—could be eligible, particularly those with localized intermediate-risk disease.

National reimbursement ends an inequality of access previously limited to certain expert centers or to patients able to finance the procedure themselves. “This reimbursement reflects a shift toward more targeted medicine, based on appropriateness of care: the right treatment for the right patient at the right time,” says Prof. Matthieu Durand.

Beyond technological performance, this approach is part of a broader movement toward therapeutic de-escalation in urologic oncology. Long-term oncologic outcomes and refined patient selection criteria will now need to be documented to determine whether this focal strategy can sustainably become a standard for localized prostate cancer.  

Read next: NeuroSAFE-assisted surgery: a lever to preserve continence and erectile function after prostatectomy?



About the Author
 – Elodie Vaz
Health journalist, CFPJ graduate (2023).
Élodie explores the marks diseases leave on bodies and, more broadly, on human life. A registered nurse since 2010, she spent twelve years at patients’ bedsides before exchanging her stethoscope for a notebook. She now investigates the links between environment and health, convinced that the vitality of life cannot be reduced to that of human.




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