A noninferiority within-person study comparing the accuracy of transperineal to transrectal MRI-US fusion biopsy for prostate-cancer detection.,Prostate Cancer and Prostatic Diseases

当前位置： X-MOL 学术 › Prostate Cancer Prostatic. Dis. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

A noninferiority within-person study comparing the accuracy of transperineal to transrectal MRI-US fusion biopsy for prostate-cancer detection.
Prostate Cancer and Prostatic Diseases ( IF 5.1 ) Pub Date : 2020-01-17 , DOI: 10.1038/s41391-020-0205-7
Yaara Ber ₁ , Niv Segal _{1,

2} , Shlomit Tamir ₃ , Ofer Benjaminov ₄ , Maxim Yakimov ₅ , Sivan Sela ₁ , Daniel Halstauch ₁ , Jack Baniel _{1,

2} , Daniel Kedar ₁ , David Margel _{1,

2}

Affiliation

BACKGROUND Magnetic resonance imaging (MRI) and ultrasound (US) fusion prostate-biopsies can be performed in a transrectal (TR-fusion) or transperineal (TP-fusion) approach. Prospective comparative evidence is limited. In this study we compared the detection rate of clinically-significant prostate-cancer (csPCa) within an index lesion between TR and TP-fusion. PATIENTS AND METHODS This was a prospective, noninferiority, and within-person trial. Men scheduled for MRI-US-fusion with a discrete MRI PI-RRAD ≥ 3 lesion were included. A dominant index lesion was determined for each subject and sampled by TR and TP-fusion during the same session. The order of biopsies was randomized and equipment was reset to avoid chronological and incorporation bias. For each subject, the index lesion was sampled 4-6 times in each approach. All biopsies were performed using Navigo fusion software (UC-Care, Yokneam, Israel). csPCa was defined as: Grade Group ≥ 2 or cancer-core length ≥ 6 mm. We used a noninferiority margin of 10% and a one-sided alpha level of 5%. RESULTS Seventy-seven patients completed the protocol. Median age was 68.2 years (IQR:64.2-72.2), median PSA was 8.9 ng/ml (IQR:6.18-12.2). Ten patients (13%) were biopsy naive, others (87%) had a previous biopsy. csPCa was detected in 32 patients (42%). All of these cases were detected by TP-fusion, while only 20 (26%) by TR-fusion. Absolute difference for csPCa diagnosis was 15.6 (CI 90% 27.9-3.2%) in favor of TP-fusion (p = 0.029). TP-fusion was noninferior to TR-fusion. The lower boundary of the 90% confidence-interval between TP-fusion and TR-fusion was greater than zero, therefore TP-fusion was also found to be superior. Exploratory subgroup analyses showed TP-fusion was consistently associated with higher detection rates of csPCa compared with TR-fusion in patient and index-lesion derived subgroups (size, location, PI-RADS, PSA, and biopsy history). CONCLUSIONS In this study, TP-fusion biopsies were found to be noninferior and superior to TR-fusion biopsies in detecting csPCa within MRI-visible index lesion. Centers experienced in both TP and TR-fusion should consider these results when choosing biopsy method.

中文翻译：

一项非劣效性内部研究，比较经会阴与经直肠MRI-US融合活检在前列腺癌检测中的准确性。

背景技术磁共振成像（MRI）和超声（US）融合前列腺活检可以以经直肠（TR-融合）或经会阴（TP-融合）的方式进行。前瞻性比较证据有限。在这项研究中，我们比较了TR和TP融合之间的指标病变内临床上重要的前列腺癌（csPCa）的检出率。患者和方法这是一项前瞻性，非自卑性和个人内部试验。包括计划进行MRI-US融合且离散MRI PI-RRAD≥3个病变的男性。确定每个受试者的优势指数病变，并在同一疗程中通过TR和TP融合进行采样。随机选择活检顺序，并重置设备以避免按时间顺序和合并偏差。对于每个受试者，在每种方法中均对指标病变进行了4-6次采样。所有活检均使用Navigo融合软件（UC-Care，以色列约克尼姆）进行。csPCa的定义为：≥2级组或癌芯长度≥6 mm。我们使用了10％的非自卑裕度和5％的单侧alpha水平。结果77例患者完成了方案。中位年龄为68.2岁（IQR：64.2-72.2），中位PSA为8.9 ng / ml（IQR：6.18-12.2）。初次活检的患者有10例（13％），以前曾进行过活检的患者（87％）。在32例患者中检测到csPCa（42％）。所有这些病例均通过TP融合检出，而仅20例（26％）通过TR融合检出。csPCa诊断的绝对差异为15.6（CI 90％为27.9-3.2％），有利于TP融合（p = 0.029）。TP融合不逊于TR融合。TP融合和TR融合之间90％置信区间的下边界大于零，因此，TP融合也被认为是更好的。探索性亚组分析显示，与患者和指数病变衍生亚组（大小，位置，PI-RADS，PSA和活检历史）相比，TP融合与csPCa的检出率高于TR融合。结论在这项研究中，发现TP融合活检在MRI可见指数病变内检测csPCa方面不劣于TR融合活检。TP和TR融合经验丰富的中心在选择活检方法时应考虑这些结果。发现TP融合活检在MRI可见指数病变内检测csPCa方面不劣于TR融合活检。TP和TR融合经验丰富的中心在选择活检方法时应考虑这些结果。发现TP融合活检在MRI可见指数病变内检测csPCa方面不劣于TR融合活检。TP和TR融合经验丰富的中心在选择活检方法时应考虑这些结果。

更新日期：2020-01-17

点击分享查看原文

点击收藏

公开下载

阅读更多本刊最新论文本刊介绍/投稿指南11