Focal One® is a computer-controlled medical device for the treatment of localised prostate cancer by focused ultrasound (HIFU = High Intensity Focused Ultrasound). The energy is delivered via an endorectal probe. The ultrasound waves travel through the rectal wall and are focused on a part of the prostate. This focusing produces intense heat, resulting in tissue destruction within the target area. The treatment lasts between 30 minutes and 2 hours and can be performed under loco-regional anaesthesia.
Focal One® is a non-invasive treatment option that allows for a precise, local treatment in one session, that can be repeated if necessary, with a short hospital stay and few side effects. In the event of incomplete results, the choice of therapeutic options is wide and includes retreatment with Focal One®.
Focal One® may be indicated as:
- a first line option for patients with localised cancer, stage T1-T2 (Gleason 6 or 7, PSA less than 15), according to their age and general condition.
- a salvage therapy option for patients with local recurrence of prostate cancer initially treated by radiotherapy.
HIFU for prostate cancer
HIFU uses a high intensity convergent ultrasound beam generated by piezoelectric transducers. This focusing of ultrasound waves into one point greatly increases the temperature around the focal point, thus resulting in tumour destruction i.e. pathological biological tissue.
The application of HIFU for prostate cancer treatment involves focusing high intensity focused ultrasound to destroy, by heat, prostatic tissue affected by cancer, without damaging surrounding tissue. This technique is non-invasive because it avoids incision, allows loco-regional anaesthesia and limits the characteristic complications of prostate cancer treatment (incontinence or impotence).
In 2013 and 2014, two prospective cohort studies demonstrated the long-term (10 years) results of whole gland HIFU as a first-line option and have validated its effectiveness: according to the cancer risk, the specific survival rate at 10 years is between 92 and 99%; survival rate without metastases at 10 years is between 86% and 100%. These results, which are completely comparable to the best radical surgery results, demonstrate that HIFU is an effective first-line treatment option for localised prostate cancer.