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新型双参数 MRI 和靶向活检可改善临床怀疑前列腺癌男性的风险分层 (IMPROD 试验)。

Novel biparametric MRI and targeted biopsy improves risk stratification in men with a clinical suspicion of prostate cancer (IMPROD Trial).

机构信息

Department of Diagnostic Radiology, University of Turku, Turku, Finland.

Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland.

出版信息

J Magn Reson Imaging. 2017 Oct;46(4):1089-1095. doi: 10.1002/jmri.25641. Epub 2017 Feb 6.

DOI:10.1002/jmri.25641
PMID:28165653
Abstract

PURPOSE

To evaluate the role of a 3T biparametric magnetic resonance imaging (bpMRI), T -weighted imaging, and three separate diffusion-weighted imaging acquisitions combined with targeted biopsy (TB) for improving risk stratification of men with elevated prostate-specific antigen (PSA).

MATERIALS AND METHODS

Between March 2013 and February 2015, 175 men with a clinical suspicion of prostate cancer (PCa) were offered bpMRI (NCT01864135) based on a suspicion of PCa (two repeated PSA measurements in the range 2.5-20.0 ng/ml and/or abnormal digital rectal examination). Men with an equivocal to high suspicion of PCa had two TBs of the dominant lesion using cognitive ultrasound guidance, followed by systematic biopsy (SB). Men with a low to very low suspicion had only SB. In total, 161 (161/175, 92%) prospectively enrolled men completed the trial and were included in the final analyses. The primary endpoint of the trial was the cancer detection rate (CDR) of TB and SB. Clinically significant cancer (SPCa) was defined as Gleason score ≥3 + 4.

RESULTS

TB compared with SB had higher CDR for SPCa (45%, 72/161 vs. 39%, 63/161, respectively; P > 0.05) and a lower CDR for Gleason score 3 + 3 (8%, 15/161 vs. 16%, 30/161; P < 0.05). Restricting biopsy to men with equivocal to highly suspicious bpMRI findings would have resulted in a 24% (38/161) reduction in the number of men undergoing biopsy, while missing 4 (2%) with SPCa. All anonymized datasets, including bpMRI reports and follow up information, are freely available on the trial server.

CONCLUSION

Prebiopsy bpMRI and TB in men with a clinical suspicion of PCa improved risk stratification.

LEVEL OF EVIDENCE

1 Technical Efficacy: Stage 5 J. Magn. Reson. Imaging 2017;46:1089-1095.

摘要

目的

评估 3T 双参数磁共振成像(bpMRI)、T1 加权成像和三个单独的扩散加权成像采集联合靶向活检(TB)在提高前列腺特异性抗原(PSA)升高男性的风险分层中的作用。

材料与方法

2013 年 3 月至 2015 年 2 月,175 名临床怀疑患有前列腺癌(PCa)的男性接受了 bpMRI(NCT01864135)检查,检查基于对 PCa 的怀疑(两次 PSA 测量结果在 2.5-20.0ng/ml 范围内且/或直肠指检异常)。可疑至高度可疑 PCa 的男性接受了两次认知超声引导下的优势病灶 TB,然后进行系统活检(SB)。低度至低度可疑的男性仅进行 SB。共有 161 名(161/175,92%)前瞻性入组的男性完成了试验,并纳入最终分析。试验的主要终点是 TB 和 SB 的癌症检出率(CDR)。临床显著癌症(SPCa)定义为 Gleason 评分≥3+4。

结果

与 SB 相比,TB 对 SPCa 的 CDR 更高(45%,72/161 比 39%,63/161,P>0.05),而对 Gleason 评分 3+3 的 CDR 更低(8%,15/161 比 16%,30/161,P<0.05)。将活检限制在可疑至高度可疑 bpMRI 结果的男性中,将使接受活检的男性数量减少 24%(38/161),但会漏诊 4 名(2%)SPCa 患者。所有匿名数据集,包括 bpMRI 报告和随访信息,均可在试验服务器上免费获得。

结论

在临床怀疑 PCa 的男性中,术前 bpMRI 和 TB 可改善风险分层。

证据水平

1 技术功效:第 5 阶段 J. Magn. Reson. Imaging 2017;46:1089-1095.

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