MR 影像引导下前列腺癌的聚焦激光消融术：I 期临床试验。
MR imaging-guided focal laser ablation for prostate cancer: phase I trial.
机构信息
Department of Radiology, University of Chicago, 5841 S Maryland Ave, Mail Code 2026, Chicago, IL, 60637, USA.
出版信息
Radiology. 2013 Jun;267(3):932-40. doi: 10.1148/radiol.13121652. Epub 2013 Feb 25.
PURPOSE
To evaluate the feasibility and safety of magnetic resonance (MR) imaging-guided laser-based thermotherapy in men with clinically low-risk prostate cancer and a concordant lesion at biopsy and MR imaging.
MATERIALS AND METHODS
This HIPAA-compliant phase I prospective study was approved by the institutional review board. Informed consent was obtained from all patients. Transperineal MR imaging-guided focal laser ablation for clinically low-risk prostate cancer was performed in patients with a Gleason score of 7 or less in three or fewer cores limited to one sextant obtained with transrectal ultrasonography (US)-guided biopsy and a concordant lesion at MR imaging. Lesions were targeted with a laser ablation system. Periprocedural complications were recorded. The International Prostate Symptom Score (IPSS) and the Sexual Health Inventory for Men (SHIM) score were collected before and after the procedure. MR imaging-guided biopsy of the ablation zone was performed 6 months after treatment. The prostate-specific antigen level, IPSS, and SHIM score before and after ablation were compared by using the Wilcoxon signed rank test.
RESULTS
Treatment was successfully completed in nine patients (procedure duration, 2.5-4 hours; mean laser ablation duration, 4.3 minutes). Immediate contrast-enhanced posttreatment MR imaging showed a hypovascular defect in eight patients. Self-resolving perineal abrasion and focal paresthesia of the glans penis each occurred in one patient. The mean (± standard deviation) IPSS and SHIM score at baseline were 5.8 ± 5.3 and 19.0 ± 8.0, respectively. Average score changes were not significantly different from zero during follow-up (P = .18-.99). MR imaging-guided biopsy of the ablation zone showed no cancer in seven patients (78%) and Gleason grade 6 cancer in two (22%).
CONCLUSION
Transperineal MR imaging-guided focal laser ablation appears to be a feasible and safe focal therapy option for clinically low-risk prostate cancer.
目的
评估磁共振（MR）成像引导下激光热疗在经直肠超声（TRUS）引导活检中发现的前列腺癌临床低危、MR 成像显示局灶性病变且 Gleason 评分为 7 分及以下且累及 3 个及以下核心且仅限于一个象限的患者中的可行性和安全性。
材料与方法
本 HIPAA 合规性、前瞻性研究获得了机构审查委员会的批准。所有患者均签署了知情同意书。对经 TRUS 引导活检发现前列腺癌临床低危、Gleason 评分为 7 分及以下且累及 3 个及以下核心且仅限于一个象限和 MR 成像显示局灶性病变的患者，行经会阴 MR 成像引导下激光消融术。用激光消融系统对病变进行靶向治疗。记录围手术期并发症。术前和术后分别收集国际前列腺症状评分（IPSS）和男性性功能健康问卷（SHIM）评分。治疗后 6 个月，对消融区域进行 MR 成像引导下活检。采用 Wilcoxon 符号秩检验比较消融前后前列腺特异性抗原水平、IPSS 和 SHIM 评分。
结果
9 例患者成功完成治疗（手术时间 2.5-4 小时；平均激光消融时间 4.3 分钟）。即刻增强后 MR 成像显示 8 例患者出现低血供缺陷。1 例患者出现会阴自发性擦伤，1 例患者出现龟头局灶性感觉异常。基线时的平均（±标准差）IPSS 和 SHIM 评分为 5.8±5.3 和 19.0±8.0。随访期间，平均评分变化与零值无显著差异（P=0.18-0.99）。7 例（78%）患者的消融区 MR 成像引导下活检未见肿瘤，2 例（22%）患者为 Gleason 分级 6 级肿瘤。
结论
经会阴 MR 成像引导下激光消融术似乎是一种治疗前列腺癌临床低危、MR 成像显示局灶性病变的可行且安全的局部治疗方法。
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