My treatment was effective, performed on an outpatient basis, and precisely targeted, allowing me to return quickly to my daily activities.
HIFU treatment procedure
Focal One® - HIFU treatment procedure
Treatment is administered in a single session, under general or locoregional anesthetic, as the patient and anesthetist deem most appropriate. The patient is positioned lying down on their right side (in a fetal position). Complete immobility is required during treatment. A HIFU probe is introduced via the anus and positioned in the rectum, at the level of the prostate. The surgeon marks out the edges of the gland, takes markers, and then determines the area to be treated on the control screen. Treatment can then start to reach the volume previously defined. The robotic machine moves the focal point with extreme precision between each pulse in the target zone on an image in real time and under the continuous monitoring of the surgeon (robotic-assisted surgical navigation). It is technically possible to destroy a volume that ranges from a small area (focal treatment) to almost the whole of the prostate gland, thereby enabling treatment to be personalized. Session duration varies from around 30 to 90 minutes, depending on the prostatic volume treated.
Why does a urinary catheter need to be used?
A urinary catheter is fitted by the surgeon because prostate edema linked to the heat occurs after treatment, and may temporarily compress the urinary canal (urethra) and cause a urine blockage (9%). The catheter allows for the normal evacuation of urine until the edema regresses (from 1 to 8 days, depending on the case).
Is the treatment painful?
The treatment itself is not painful, as it is carried out under anesthetic. Some discomfort may be experienced for a few hours after treatment. There is no burning sensation or external scarring.
What happens after treatment?
Eating resumes the evening of treatment and the catheter is generally removed 1 to 5 days later, depending on the facility’s protocol. The patient can return home on the same day of treatment (with an indwelling catheter) or after catheter removal. A urine test will be requested if pain persists when urinating. If a urinary tract infection is detected (4.5%), the attending physician can prescribe antibiotic treatment specifically targeting the germs present in the urine. During this period, the patient may suffer some discomfort: slight bleeding when starting to urinate, frequent, sometimes urgent urination, potential urine leaks upon exertion, and sometimes the elimination of small whitish discharge. Infections with fever are rare but possible (1.5%) and, if occurring, will require targeted antibiotic treatment.
Is long-term monitoring necessary?
PSA tests must be performed every 6 months. Control biopsies may be taken, according to protocol. If any residual cancer focus is detected (around 15 % of cases), complementary treatment may be prescribed in addition to active monitoring, which may include, depending on the situation: HIFU treatment, prostate ablation, external radiotherapy, and/or hormonal treatment (blockage).
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Focal One treatment in images
1 – The patient lies on their right side during treatment.
2 – The image shows the probe’s position relative to the rectum.
3 – The proximity of the prostate to the rectum wall allows for optimal treatment.
HIFU treatment results
Non-inferiority of HIFU treatment compared with surgery
In 2024, a published French trial(1) including more than 3300 patients enrolled at 46 sites proved the non-inferiority of HIFU treatment compared with standard surgery, in terms of oncological results at 30 months.
LEGAL NOTICE – INS-491G – 2022/04/28 – 394 804 447 RCS Lyon
Focal One is manufactured by EDAP TMS. This medical device is a regulated health care product, which bears CE marking in accordance with this regulation. Focal One is intended to use high-intensity focused ultrasound introduced via the rectum to destroy localized prostate adenocarcinoma. You must consult with your urologist.