Focal Therapy for Localized Prostate Cancer: A Phase I/II Trial

Focal Therapy for Localized Prostate Cancer: A Phase I/II Trial
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DOI:
10.1016/j.juro.2010.11.079
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发表时间:
2011-04-01
期刊:
影响因子:
6.6
通讯作者:
Emberton, M.
Emberton, M.
中科院分区:
医学1区
文献类型:
--
作者:
Ahmed, H. U.;Freeman, A.;Emberton, M.

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目的:患有局限性前列腺癌的男性目前面临着治疗整个前列腺癌的多种治疗选择。这些都会导致严重的性和尿路副作用。聚焦治疗提供了一种新的策略,它针对癌症而不是前列腺癌,试图保护组织和功能。材料和方法:进行了一项伦理学委员会批准的前瞻性试验,以确定使用高强度聚焦超声进行聚焦治疗的副作用。多参数磁共振成像(T2加权、动态增强、弥散加权)和模板经会阴前列腺标测活检用于识别单侧病变。使用有效问卷评估泌尿生殖系统副作用和生活质量结果。治疗后6个月取材,随访至12个月。结果:共20例男性患者接受了高强度聚焦超声半消融治疗。前列腺特异性抗原平均7.3 ng/ml(SD 2.8,3.4~11.8),平均年龄60.4岁(SD 5.4,50~70)。在这些男性中,25%的人患有低风险癌症,75%的人患有中等风险癌症。95%的男性(19/20)恢复了足以进行穿透性性行为的勃起。此外,90%的男性(18/20)是无垫、无渗漏的大便,而95%的男性是无垫的。12个月时平均前列腺特异性抗原下降80%至1.5 ng/ml(SD 1.3)。89%的男性(17/19,1拒绝活检)没有任何癌症的组织学证据,也没有组织学证据表明治疗的肺叶有大量或Gleason 7或更大的癌症。此外,89%的男性在12个月时达到了无垫、无渗漏、勃起足以性交和癌症控制的三位一体状态。结论:我们的结果似乎足够有希望支持进一步评估焦点治疗作为一种策略,以减少与标准全腺治疗相关的一些伤害和成本。
Purpose: Men with localized prostate cancer currently face a number of treatment options that treat the entire prostate. These can cause significant sexual and urinary side effects. Focal therapy offers a novel strategy that targets the cancer rather than the prostate in an attempt to preserve tissue and function.Materials and Methods: A prospective, ethics committee approved trial was conducted to determine the side effects of focal therapy using high intensity focused ultrasound. Multiparametric magnetic resonance imaging (T2-weighted, dynamic contrast enhanced, diffusion-weighted) and template transperineal prostate mapping biopsies were used to identify unilateral disease. Genitourinary side effects and quality of life outcomes were assessed using validated questionnaires. Posttreatment biopsies were performed at 6 months and followup was completed to 12 months.Results: A total of 20 men underwent high intensity focused ultrasound hemiablation. Mean age was 60.4 years (SD 5.4, range 50 to 70) with mean prostate specific antigen 7.3 ng/ml (SD 2.8, range 3.4 to 11.8). Of the men 25% had low risk and 75% had intermediate risk cancer. Return of erections sufficient for penetrative sex occurred in 95% of men (19 of 20). In addition, 90% of men (18 of 20) were pad-free, leak-free continent while 95% were pad-free. Mean prostate specific antigen decreased 80% to 1.5 ng/ml (SD 1.3) at 12 months. Of the men 89% (17 of 19, 1 refused biopsy) had no histological evidence of any cancer, and none had histological evidence of high volume or Gleason 7 or greater cancer in the treated lobe. In addition, 89% of men achieved the trifecta status of pad-free, leak-free continence, erections sufficient for intercourse and cancer control at 12 months.Conclusions: Our results appear sufficiently promising to support the further evaluation of focal therapy as a strategy to decrease some of the harms and costs associated with standard whole gland treatments.