Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study-猫眼课题宝

DOI：

10.1016/s0140-6736(16)32401-1

发表时间：

2017-02-25

期刊：

LANCET

影响因子：

168.9

通讯作者：

中科院分区：

医学1区

文献类型：

作者：

Ahmed, Hashim U.;Bosaily, Ahmed El-Shater;Emberton, Mark

背景血清前列腺特异性抗原高的男性通常会接受经直肠超声引导下的前列腺活检（TRUS 活检）。 TRUS 活检可能会引起副作用，包括出血、疼痛和感染。用作分诊测试的多参数磁共振成像 (MP-MRI) 可能会让男性避免不必要的 TRUS 活检并提高诊断准确性。方法我们进行了这项多中心、配对队列验证性研究，以根据参考测试（模板前列腺标测活检 [TPM-活检]）测试 MP-MRI 和 TRUS 活检的诊断准确性。前列腺特异性抗原浓度高达 15 ng/mL、之前未进行活检的男性接受 1.5 Tesla MP-MRI，然后进行 TRUS 活检和 TPM 活检。每项测试的进行和报告都是在不考虑其他测试结果的情况下进行的。具有临床意义的癌症定义为格里森评分 >= 4 + 3 或最大癌症核心长度 6 毫米或更长。这项研究已在 ClinicalTrials.gov 上注册，NCT01292291。结果 2012 年 5 月 17 日至 2015 年 11 月 9 日期间，我们招募了 740 名男性，其中 576 人接受了 1.5 Tesla MP-MRI，随后进行了 TRUS 活检和 TPM 活检。在 TPM 活检中，576 名男性中有 408 名 (71%) 患有癌症，576 名患者中有 230 名 (40%) 具有临床意义。对于有临床意义的癌症，MP-MRI 比 TRUS 活检（48%、42-55%；p

Background Men with high serum prostate specific antigen usually undergo transrectal ultrasound-guided prostate biopsy (TRUS-biopsy). TRUS-biopsy can cause side-effects including bleeding, pain, and infection. Multi-parametric magnetic resonance imaging (MP-MRI) used as a triage test might allow men to avoid unnecessary TRUS-biopsy and improve diagnostic accuracy.Methods We did this multicentre, paired-cohort, confirmatory study to test diagnostic accuracy of MP-MRI and TRUS-biopsy against a reference test (template prostate mapping biopsy [TPM-biopsy]). Men with prostate-specific antigen concentrations up to 15 ng/mL, with no previous biopsy, underwent 1.5 Tesla MP-MRI followed by both TRUS-biopsy and TPM-biopsy. The conduct and reporting of each test was done blind to other test results. Clinically significant cancer was defined as Gleason score >= 4 + 3 or a maximum cancer core length 6 mm or longer. This study is registered on ClinicalTrials.gov, NCT01292291.Findings Between May 17, 2012, and November 9, 2015, we enrolled 740 men, 576 of whom underwent 1.5 Tesla MP-MRI followed by both TRUS-biopsy and TPM-biopsy. On TPM-biopsy, 408 (71%) of 576 men had cancer with 230 (40%) of 576 patients clinically significant. For clinically signifi cant cancer, MP-MRI was more sensitive (93%, 95% CI 88-96%) than TRUS-biopsy (48%, 42-55%; p

Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study

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