Focal Ablation Targeted to the Index Lesion in Multifocal Localised Prostate Cancer: a Prospective Development Study
Focal Ablation Targeted to the Index Lesion in Multifocal Localised Prostate Cancer: a Prospective Development Study
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DOI：
10.1016/j.eururo.2015.01.030
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发表时间：
2015-12-01
期刊：
影响因子：
23.4
通讯作者：
Emberton, Mark
中科院分区：
文献类型：
--
作者：
Ahmed, Hashim U.;Dickinson, Louise;Emberton, Mark
背景资料：虽然局部前列腺癌是多灶性的，在大多数情况下，指数病变可能是负责疾病progression.Objective：要确定早期泌尿生殖系统功能和癌症控制指标病变ablation.Design，设置，和participants结果：这是一个单中心的前瞻性发展研究，其中56名男子进行了治疗（2009年7月至2011年1月）。平均年龄为63.9岁（标准差5.8），前列腺特异性抗原（PSA）中位数为7.4 ng/ml（四分位数间距[IQR] 5.6-9.5）。有7（12.5%）低风险，47（83.9%）中风险，和两个（3.6%）高风险cancer.Intervention：多参数磁共振成像（mpMRI）和前列腺活检定位疾病，其次是指数病变消融使用高强度聚焦超声。结果测量和统计分析：主要结果是使用经验证的问卷测量的泌尿生殖系统副作用。次要结局包括在12个月时没有临床显著疾病。结果和局限性：复合材料的无泄漏，无垫勃起，勃起足以穿透从基线频率40/56（71.4%）下降到33/56（58.9%）在12个月。无衬垫和无泄漏、无衬垫的瓣膜分别在48/52（92.3%）和46/50（92.0%）例患者中得以保留。30/39例（76.9%）患者保留了足以进行性交的勃起。中位PSA最低值降至2.4 ng/ml（IQR 1.6-4.1）。在12个月时，42/52（80.8%）例患者的组织学上不存在具有临床意义的癌症，85.7%（48/56）的患者没有可测量的前列腺癌（活检和/或mpMRI）。2例（3.6%）患者在基线时未检测到的未治疗区域有临床显著疾病。主要研究的局限性是短期的后续duty.Conclusions：指标病变消融率较低的泌尿生殖系统的副作用和可接受的短期没有临床意义的癌症。比较有效性试验需要评估癌症控制结果对radical therapy.Patient摘要：在这项研究中，我们看看是否有可能治疗最大和最高级别的肿瘤的男性谁有一个以上的已知前列腺肿瘤。我们发现靶向消融的副作用很低，早期癌症控制率可接受。需要更大规模的研究和更长时间的随访。试验注册：NCT 00988130（C）2015欧洲泌尿外科协会。Elsevier B. V.出版，保留所有权利。
Background: Although localised prostate cancer is multifocal in most instances, the index lesion might be responsible for disease progression.Objective: To determine the early genitourinary functional and cancer control outcomes of index lesion ablation.Design, setting, and participants: This was a single-centre prospective development study in which 56 men were treated (July 2009-January 2011). The mean age was 63.9 yr (standard deviation 5.8) and median prostate-specific antigen (PSA) was 7.4 ng/ml (interquartile range [IQR] 5.6-9.5). There were seven (12.5%) low-risk, 47 (83.9%) intermediate-risk, and two (3.6%) high-risk cancers.Intervention: Multiparametric magnetic resonance imaging (mpMRI) and prostate biopsies to localise disease, followed by index lesion ablation using high-intensity focused ultrasound. Outcome measurements and statistical analysis: Primary outcomes were genitourinary side effects measured using validated questionnaires. Secondary outcomes included absence of clinically significant disease at 12 mo.Results and limitations: The composite of leak-free, pad-free continence, and erections sufficient for penetration decreased from a baseline frequency of 40/56 (71.4%) to 33/56 (58.9%) at 12 mo. Pad-free and leak-free, pad-free continence was preserved in 48/52 (92.3%) and 46/50 (92.0%) patients, respectively. Erections sufficient for intercourse were preserved in 30/39 (76.9%) patients. The median PSA nadir decreased to 2.4 ng/ml (IQR 1.6-4.1). At 12 mo, 42/52 (80.8%) patients had histological absence of clinically significant cancer and 85.7% (48/56) had no measurable prostate cancer (biopsy and/or mpMRI). Two (3.6%) patients had clinically significant disease in untreated areas not detected at baseline. The main study limitation is the short follow-up duration.Conclusions: Index lesion ablation had low rates of genitourinary side effects and acceptable short-term absence of clinically significant cancer. Comparative effectiveness trials are required to assess cancer control outcomes against radical therapy.Patient summary: In this study we looked at whether it is possible to treat the largest and highest-grade tumour in men who have more than one known prostate tumour. We show that the side effects of targeted ablation were low, with acceptable rates of early cancer control. Larger studies with longer follow-up are needed. Trial registration: NCT00988130 (C) 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.