HIFU therapy of localized prostate cancer using image-guided robotic hifu «Focal one»

Introduction. Prostate cancer (PCa) is the second most commonly diagnosed malignant tumor in men after lung cancer and is the fifth leading cause of death worldwide. In November 2019, the spectrum of alternative treatment for PCa was added by a novel minimally invasive method, namely high-intensity focused ultrasound (HIFU) using the latest Focal One machine (with the possibility of combining intraoperative ultrasound and preoperative MRI data).

Materials and methods. During the period from November 2019 to November 2021, HIFU using Focal One device (manufactured by EDAP, France) was performed in 75 patients with PCa. Total ablation was done in 45 cases, while 30 patients undergone to focal prostate ablation. The average age of the patients was 62.7 (51–80) years, the total PSA level was 9.3 (3.2–15.5) ng/ml and the prostate volume was 32.0 (11–35) cc. The maximum urinary rate was 13.3 (6.3–36) ml/s, IPSS score was 7 (3–25) points, IIEF-5 score was 18 (4–25). Clinical stage cТ1сN0M0 was diagnosed in 60 patients, Т1bN0M0 in 4 patients, Т2N0M0 in 11 patients. In 21 cases, transurethral resection of the prostate was performed within 4–6 weeks prior to total ablation. Before surgery, all patients underwent magnetic resonance imaging (MRI) of the pelvis with intravenous contrast and PIRADS V2 assessment. MRI data were used intraoperatively for precision planning of the procedure.

Results. In all patients, the procedure was performed under endotracheal anesthesia in accordance with the technical recommendations of the manufacturer. Prior to surgery, a silicone urethral catheter of 16 or 18 Ch was placed. The average duration of the intervention was 101 (56–147) minutes. The postoperative period was uneventful in all cases.Patients received antibiotic therapy via parenteral route for 4 days, followed by oral administration for another 10 days, as well as alpha-blockers (at least 1 month after procedure). After removal of urethral catheter on the 4th day, all patients started to void. In 9 cases there was acute urinary retention in the evening and in 4 patients in the next morning, requiring temporary bladder catheterization. A year after the procedure, 53 patients were fully examined: the average total PSA level in patients who underwent total ablation (n=53) was 0.96±0.11 ng/ml, the IPSS score was 6.9±0,6 points (no difference compared to baseline). Follow-up biopsy revealed PCa in 6 patients; in other cases, prostate fibrosis was determined.

Conclusions. HIFU in patients with localized PCa using image-guided robotic HIFU (Focal One) is promising and feasible. This method has shown good oncological results with a short follow-up period. It is advisable to carry out further prospective analysis.