Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY 10029;
Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029.
Proc Natl Acad Sci U S A. 2019 Sep 10;116(37):18590-18596. doi: 10.1073/pnas.1906929116. Epub 2019 Aug 26.
Biocompatible gold nanoparticles designed to absorb light at wavelengths of high tissue transparency have been of particular interest for biomedical applications. The ability of such nanoparticles to convert absorbed near-infrared light to heat and induce highly localized hyperthermia has been shown to be highly effective for photothermal cancer therapy, resulting in cell death and tumor remission in a multitude of preclinical animal models. Here we report the initial results of a clinical trial in which laser-excited gold-silica nanoshells (GSNs) were used in combination with magnetic resonance-ultrasound fusion imaging to focally ablate low-intermediate-grade tumors within the prostate. The overall goal is to provide highly localized regional control of prostate cancer that also results in greatly reduced patient morbidity and improved functional outcomes. This pilot device study reports feasibility and safety data from 16 cases of patients diagnosed with low- or intermediate-risk localized prostate cancer. After GSN infusion and high-precision laser ablation, patients underwent multiparametric MRI of the prostate at 48 to 72 h, followed by postprocedure mpMRI/ultrasound targeted fusion biopsies at 3 and 12 mo, as well as a standard 12-core systematic biopsy at 12 mo. GSN-mediated focal laser ablation was successfully achieved in 94% (15/16) of patients, with no significant difference in International Prostate Symptom Score or Sexual Health Inventory for Men observed after treatment. This treatment protocol appears to be feasible and safe in men with low- or intermediate-risk localized prostate cancer without serious complications or deleterious changes in genitourinary function.
设计用于吸收高组织透明度波长光的生物相容性金纳米粒子一直是生物医学应用的研究热点。这些纳米粒子能够将吸收的近红外光转化为热能并诱导高度局部的热疗,已被证明对光热癌症治疗非常有效,在多种临床前动物模型中导致细胞死亡和肿瘤消退。在这里,我们报告了一项临床试验的初步结果,其中使用激光激发的金-硅纳米壳(GSN)与磁共振-超声融合成像结合,对前列腺内的低-中等级别肿瘤进行聚焦消融。总体目标是提供前列腺癌的高度局部区域控制,同时还能大大降低患者的发病率并改善功能结果。这项初步设备研究报告了 16 例诊断为低风险或中风险局限性前列腺癌患者的可行性和安全性数据。在 GSN 输注和高精度激光消融后,患者在 48 至 72 小时进行前列腺多参数 MRI,然后在 3 个月和 12 个月进行术后 mpMRI/超声靶向融合活检,以及在 12 个月进行标准的 12 核系统活检。在 94%(15/16)的患者中成功实现了 GSN 介导的焦点激光消融,治疗后国际前列腺症状评分或男性性功能健康调查无显著差异。对于低风险或中风险局限性前列腺癌的男性,这种治疗方案似乎是可行且安全的,没有严重的并发症或泌尿生殖功能的有害变化。