A Multi-Institutional Study of Magnetic Resonance/Ultrasound Fusion-Guided Nanoparticle-Directed Focal Therapy for Prostate Ablation.

IF 5.9 2区 医学 Q1 UROLOGY & NEPHROLOGY
Steven E Canfield, Arvin K George, Joshua S Jue, Sara C Lewis, Matthew S Davenport, Varaha S Tammisetti, Mahir Maruf, Leonardo D Borregalaes, Yara Kadria-Vili, Jon A Schwartz, Jennifer West, Naomi J Halas, Ardeshir R Rastinehad
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引用次数: 0

Abstract

Purpose: Focal therapy aims to provide a durable oncologic treatment option for men with prostate cancer (PCa), while preserving their quality of life. Most focal therapy modalities rely on the direct tissue effect, resulting in a possible nontargeted approach to ablation. Here, we report the results of the first human feasibility trial utilizing nanoparticle-directed focal photothermal ablation for PCa.

Materials and methods: A prospective, open-label, single-arm, multicenter study of men with localized PCa in Gleason Grade Group 1 to 3 was conducted. Men received a single infusion of gold nanoparticles (AuroShells), followed by magnetic resonance (MR)/ultrasound (US) fusion-guided laser excitation of the target tissue to induce photothermal ablation. MRI was used to assess the effectiveness of prostate tissue ablation at 48 to 96 hours, 3 months, and 12 months post treatment. At 3 months, a targeted fusion biopsy of the lesion(s) was conducted. At 12 months, a targeted fusion biopsy and standard templated biopsy were performed. Treatment success was determined based on a negative MR/US fusion biopsy outcome within the treated area.

Results: Forty-six men were enrolled in the study, and 44 men with 45 lesions completed nanoparticle infusion and laser treatment. The mean PSA level at baseline was 9.5 ng/mL, which decreased to 5.9 ng/mL at 3 months and to 4.7 ng/mL at 12 months (P < .0001). The oncologic success rates at 3 and 12 months resulted in 29 (66%) and 32 (73%) of 44 patients, respectively, being successfully treated, confirmed with negative MR/US fusion biopsies within the ablation zone. Among Gleason Grade Group, maximum lesion diameter on MRI, prostate volume, and Prostate Imaging Reporting and Data System scoring, the maximum lesion diameter was significantly associated with the odds of treatment failure at 12 months (P = .046).

Conclusions: Nanoparticle-directed focal laser ablation of neoplastic prostate tissue resulted in 73% of patients with successful treatment at 12 months post treatment, confirmed by negative MR/US fusion biopsy of the treated lesion and a systematic biopsy.

Clinical trial registration no.: 02680535.

MR/US 融合引导的纳米粒子前列腺消融病灶疗法的多机构研究。
简介病灶治疗旨在为前列腺癌(PCa)患者提供一种持久的肿瘤治疗方案,同时保证他们的生活质量。大多数病灶治疗模式都依赖于直接组织效应,这可能导致一种非靶向消融方法。在此,我们报告了利用纳米粒子引导的病灶光热消融治疗 PCa 的首个人体可行性试验的结果:一项前瞻性开放标签、单臂多中心研究针对患有局部 PCa 的男性进行,患者的 Gleason 等级组(GGG)为 1 至 3。男性患者接受一次金纳米粒子(AuroShells)输注,然后在 MR/US 融合引导下用激光激发靶组织,诱导光热消融。核磁共振成像用于评估治疗后 48 至 96 小时、3 个月和 12 个月的前列腺组织消融效果。3 个月时,对病灶进行靶向融合活检。12 个月时,进行靶向融合活检和标准模板活检。治疗成功与否取决于治疗区域内的 MR/US 融合活检结果是否为阴性:46名男性参加了这项研究,44名男性的45个病灶完成了纳米颗粒输注和激光治疗。基线PSA平均水平为9.5纳克/毫升,3个月时下降了5.9纳克/毫升,12个月时下降了4.7纳克/毫升(P < .0001)。根据 3 个月和 12 个月的肿瘤学成功率,44 例患者中分别有 29 例(66%)和 32 例(73%)治疗成功,消融区内的 MR/US 融合活检结果均为阴性。在GGG、MRI最大病灶直径(MLD)、前列腺体积和PI-RADS评分中,MLD与12个月时治疗失败的几率显著相关(P = .046):结论:对前列腺肿瘤组织进行纳米粒子定向病灶激光消融术可使73%的患者在治疗后12个月时获得成功治疗,治疗病灶的MR/US融合活检和系统活检结果均为阴性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Urology
Journal of Urology 医学-泌尿学与肾脏学
CiteScore
11.50
自引率
7.60%
发文量
3746
审稿时长
2-3 weeks
期刊介绍: The Official Journal of the American Urological Association (AUA), and the most widely read and highly cited journal in the field, The Journal of Urology® brings solid coverage of the clinically relevant content needed to stay at the forefront of the dynamic field of urology. This premier journal presents investigative studies on critical areas of research and practice, survey articles providing short condensations of the best and most important urology literature worldwide, and practice-oriented reports on significant clinical observations.
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