Govorov A V, Vasilyev A O, Alaverdyan A I, Kolontarev K B, Pushkar D Y
A.I. Evdokimov Moscow State University of Medicine and Dentistry of Minzdrav of Russia, Moscow, Russia.
Municipal clinical hospital named after S.I. Spasokukotskiy of the Moscow Healthcare Department, Moscow, Russia.
Urologiia. 2023 May(2):83-89.
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).
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 c1N0M0 was diagnosed in 60 patients, 1bN0M0 in 4 patients, 2N0M0 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.
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.
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.
前列腺癌（PCa）是男性中第二常见的恶性肿瘤，仅次于肺癌，是全球第五大死因。2019年11月，一种新型微创方法——使用最新的Focal One机器的高强度聚焦超声（HIFU）（有可能结合术中超声和术前MRI数据），为PCa的替代治疗增添了新的选择。
在2019年11月至2021年11月期间，对75例PCa患者使用Focal One设备（由法国EDAP公司生产）进行了HIFU治疗。45例患者进行了完全消融，30例患者进行了局限性前列腺消融。患者的平均年龄为62.7（51 - 80）岁，总PSA水平为9.3（3.2 - 15.5）ng/ml，前列腺体积为32.0（11 - 35）cc。最大尿流率为13.3（6.3 - 36）ml/s，国际前列腺症状评分（IPSS）为7（3 - 25）分，国际勃起功能指数-5（IIEF-5）评分为18（4 - 25）。60例患者诊断为临床分期c1N0M0，4例为1bN0M0，11例为2N0M0。21例患者在完全消融前4 - 6周进行了经尿道前列腺切除术。手术前，所有患者均接受了静脉造影剂增强的盆腔磁共振成像（MRI）及前列腺影像报告和数据系统（PIRADS）V2评估。术中使用MRI数据进行手术的精确规划。
所有患者均根据制造商的技术建议在气管内麻醉下进行手术。手术前放置了16或18Ch的硅胶尿道导管。平均干预时间为101（56 - 147）分钟。所有病例术后恢复顺利。患者接受了4天的静脉抗生素治疗，随后口服抗生素10天，以及α受体阻滞剂（术后至少1个月）。术后第4天拔除尿道导管后，所有患者开始排尿。9例患者在晚上出现急性尿潴留，4例患者在第二天早上出现急性尿潴留，需要临时膀胱插管。手术后一年，对53例患者进行了全面检查：接受完全消融的患者（n = 53）平均总PSA水平为0.96±0.11 ng/ml，IPSS评分为6.9±0.6分（与基线相比无差异）。随访活检发现6例患者患有PCa；其他病例确定为前列腺纤维化。
使用图像引导的机器人HIFU（Focal One）对局限性PCa患者进行HIFU治疗是有前景且可行的。该方法在短期随访中显示出良好的肿瘤学效果。建议进行进一步的前瞻性分析。
