前列腺癌的聚焦激光烧蚀：I 期临床试验。
Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial.
机构信息
Department of Urology, University of California, Los Angeles, Los Angeles, California; Department of Bioengineering, University of California, Los Angeles, Los Angeles, California; Center for Advanced Surgical and Interventional Technology, University of California, Los Angeles, Los Angeles, California.
Department of Radiology, University of California, Los Angeles, Los Angeles, California.
出版信息
J Urol. 2016 Jul;196(1):68-75. doi: 10.1016/j.juro.2015.12.083. Epub 2015 Dec 31.
PURPOSE
Focal laser ablation is an investigational technique to treat prostate cancer in a region confined manner via coagulative necrosis. This phase I trial primarily examines the safety of transrectal magnetic resonance imaging guided (in-bore) focal laser ablation in men with intermediate risk prostate cancer. An exploratory end point is cancer control after 6 months.
MATERIALS AND METHODS
In an institutional review board approved trial we studied focal laser ablation in 8 men with intermediate risk prostate cancer diagnosed using magnetic resonance-ultrasound fusion. Focal laser ablation was performed by inserting a cylindrically diffusing, water cooled laser fiber into magnetic resonance visible regions of interest, followed by interstitial heating at 10 to 15 W for up to 3 minutes. Secondary safety monitors (thermal probes) were inserted to assess the accuracy of magnetic resonance thermometry. Comprehensive magnetic resonance-ultrasound fusion biopsy was performed after 6 months. Adverse events and health related quality of life questionnaires were recorded.
RESULTS
Focal laser ablation was successfully performed in all 8 subjects. No grade 3 or greater adverse events occurred and no changes in International Prostate Symptom Score or International Index of Erectile Function 5 were observed. Ablation zones, as measured by posttreatment magnetic resonance imaging, had a median volume of 3 cc or 7.7% of prostate volume. Prostate specific antigen decreased in 7 men (p <0.01). At followup magnetic resonance-ultrasound fusion biopsy cancer was not detected in the ablation zone in 5 men but was present outside the treatment margin in 6 men.
CONCLUSIONS
Focal laser ablation of the prostate is feasible and safe in men with intermediate risk prostate cancer without serious adverse events or changes in urinary or sexual function at 6 months. Comprehensive biopsy followup indicates that larger treatment margins than previously thought necessary may be required for complete tumor ablation.
目的
局灶性激光消融是一种通过凝固性坏死来限制治疗前列腺癌区域的研究性技术。本 I 期试验主要检查经直肠磁共振成像引导（腔内）局灶性激光消融在中危前列腺癌男性中的安全性。探索性终点是 6 个月后的癌症控制情况。
材料和方法
在一项机构审查委员会批准的试验中，我们研究了 8 名使用磁共振-超声融合诊断为中危前列腺癌的男性的局灶性激光消融。通过将圆柱形扩散、水冷激光光纤插入磁共振可见感兴趣区域，然后在 10 至 15 W 下进行间质加热，持续 3 分钟，进行局灶性激光消融。插入辅助安全监测（热探头）以评估磁共振测温的准确性。在 6 个月后进行全面的磁共振-超声融合活检。记录不良事件和健康相关生活质量问卷。
结果
8 名受试者均成功进行了局灶性激光消融。没有发生 3 级或更高级别的不良事件，国际前列腺症状评分或国际勃起功能指数 5 也没有变化。消融区，如治疗后磁共振成像测量，中位数体积为 3 cc 或前列腺体积的 7.7%。7 名男性的前列腺特异性抗原降低（p <0.01）。在随访的磁共振-超声融合活检中，5 名男性的消融区内未发现癌症，但在 6 名男性的治疗边缘外发现癌症。
结论
在没有严重不良事件或尿性功能或性功能变化的情况下，局灶性激光消融前列腺在中危前列腺癌男性中是可行且安全的，6 个月时。全面的活检随访表明，可能需要比以前认为必要的更大的治疗边缘来实现肿瘤的完全消融。
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