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.
