Delongchamps Nicolas Barry, Peltier Alexandre, Potiron Eric, Bladou Franck, Anract Julien, Diamand Romain, Robert Grégoire, Messas Aurel, Van Velthoven Roland
Department of Urology, Cochin Hospital, Assistance Publique - Hôpitaux de Paris Université Paris Cité Paris France.
Department of Urology, Jules Bordet Institute, Hôpital Universitaire de Bruxelles Université Libre de Bruxelles Brussels Belgium.
BJUI Compass. 2024 Oct 30;5(12):1307-1313. doi: 10.1002/bco2.444. eCollection 2024 Dec.
The aim of this study was to assess the precision and safety of targeted microwave ablation (TMA) using organ-based tracking (OBT) fusion, in patients with intermediate risk prostate cancer.
We conducted a prospective, multicentric trial. Eligible patients had a prostate-specific antigen (PSA) < 20 ng/mL, a magnetic resonance imaging (MRI)-visible index tumour of Gleason score 3 + 4, with largest axis ≤15 mm and distant of at least 5 mm from the rectum and apex. TMA was performed with microwave needle applicator using OBT fusion, with a transperineal or a transrectal approach. In this interim analysis, we evaluated precision, safety, urinary and sexual outcomes, and PSA density kinetics.
At this point, 37 patients were treated in five centres. Median (interquartile range) age is 68 (63-72) years. Baseline median prostate volume and PSA are of 45 (34-57) mL and 8 (6.2-10.8) ng/mL, respectively. Median largest tumour axis on T2W MRI is of 11 mm (10-13). Patients were treated under general anaesthesia or conscious IV sedation in an outpatient setting. Anaesthesia had a median duration of 78 (66-90) min. A median number of 3 (2-4) 12-W ablations of 2 to 5 min were performed per patient. After a median follow-up of 6 (2.4-10) months, we observed 58 adverse events (AE) in 22 patients. These were of Common Terminology Criteria for Adverse Events (CTCAE) grade 1, 2 and 3 in 43 (74%), 13 (22%) and 2 (4%) cases. Six (15%) patients had an acute urinary retention, five of which considered as severe AE because of rehospitalisation. We did not observe any significant difference in International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire-ejaculatory dysfunction (MSHQ-EjD) and International Index of Erectile Function (IIEF5) from baseline to last follow-up. Median PSA density evolved from 0.2 (0.1-0.3) at baseline to 0.1 (0.07-0.16) at 12 months.
These preliminary results suggest that TMA using OBT fusion is precise and safe in patients with intermediate risk localised prostate cancer. Further inclusions and follow-up are needed to assess oncological outcome.
本研究旨在评估基于器官追踪（OBT）融合技术的靶向微波消融（TMA）在中度风险前列腺癌患者中的精确性和安全性。
我们开展了一项前瞻性多中心试验。符合条件的患者前列腺特异性抗原（PSA）<20 ng/mL，磁共振成像（MRI）可见的 Gleason 评分 3+4 指数肿瘤，最大径≤15 mm，距直肠和前列腺尖至少 5 mm。使用 OBT 融合技术的微波针式消融器经会阴或经直肠途径进行 TMA。在本次中期分析中，我们评估了精确性、安全性、泌尿和性功能结局以及 PSA 密度动力学。
此时，5 个中心共治疗了 37 例患者。年龄中位数（四分位间距）为 68（63 - 72）岁。基线时前列腺体积中位数和 PSA 分别为 45（34 - 57）mL 和 8（6.2 - 10.8）ng/mL。T2W MRI 上肿瘤最大径中位数为 11 mm（10 - 13）。患者在门诊接受全身麻醉或清醒静脉镇静。麻醉持续时间中位数为 78（66 - 90）分钟。每位患者平均进行 3（2 - 4）次 12 瓦、每次 2 至 5 分钟的消融。中位随访 6（2.4 - 10）个月后，我们在 22 例患者中观察到 58 例不良事件（AE）。这些不良事件按照不良事件通用术语标准（CTCAE）分级，1 级、2 级和 3 级分别有 43（74%）例、13（22%）例和 2（4%）例。6 例（15%）患者发生急性尿潴留，其中 5 例因再次住院被视为严重 AE。从基线到末次随访，我们未观察到国际前列腺症状评分（IPSS）、男性性健康问卷 - 射精功能障碍（MSHQ - EjD）和国际勃起功能指数（IIEF5）有任何显著差异。PSA 密度中位数从基线时的 0.2（0.1 - 0.3）降至 12 个月时的 0.1（0.07 - 0.16）。
这些初步结果表明，基于 OBT 融合技术的 TMA 在中度风险局限性前列腺癌患者中是精确且安全的。需要进一步纳入患者并进行随访以评估肿瘤学结局。
