From the Urologic Oncology Branch (M.A., A.R.W., A.H.L., S.M., P.T.G., J.B., S.G., W.M.L., P.A.P.), the Biometric Research Program, Division of Cancer Treatment and Diagnosis (S.E.R., J.H.S.), the Molecular Imaging Program (S.M., P.L.C., B.T.) and the Translational Surgical Pathology Section (M.M.), Center for Cancer Research, the Division of Cancer Prevention (P.P., H.P.), the Center for Interventional Oncology (B.J.W.), and Interventional Radiology, Radiology and Imaging Sciences, National Institutes of Health Clinical Center (B.J.W.), National Cancer Institute, National Institutes of Health, Bethesda, and the Division of Urology, Department of Surgery, University of Maryland School of Medicine, Baltimore (M.S.) - all in Maryland.
N Engl J Med. 2020 Mar 5;382(10):917-928. doi: 10.1056/NEJMoa1910038.
BACKGROUND: The use of 12-core systematic prostate biopsy is associated with diagnostic inaccuracy that contributes to both overdiagnosis and underdiagnosis of prostate cancer. Biopsies performed with magnetic resonance imaging (MRI) targeting may reduce the misclassification of prostate cancer in men with MRI-visible lesions. METHODS: Men with MRI-visible prostate lesions underwent both MRI-targeted and systematic biopsy. The primary outcome was cancer detection according to grade group (i.e., a clustering of Gleason grades). Grade group 1 refers to clinically insignificant disease; grade group 2 or higher, cancer with favorable intermediate risk or worse; and grade group 3 or higher, cancer with unfavorable intermediate risk or worse. Among the men who underwent subsequent radical prostatectomy, upgrading and downgrading of grade group from biopsy to whole-mount histopathological analysis of surgical specimens were recorded. Secondary outcomes were the detection of cancers of grade group 2 or higher and grade group 3 or higher, cancer detection stratified by previous biopsy status, and grade reclassification between biopsy and radical prostatectomy. RESULTS: A total of 2103 men underwent both biopsy methods; cancer was diagnosed in 1312 (62.4%) by a combination of the two methods (combined biopsy), and 404 (19.2%) underwent radical prostatectomy. Cancer detection rates on MRI-targeted biopsy were significantly lower than on systematic biopsy for grade group 1 cancers and significantly higher for grade groups 3 through 5 (P<0.01 for all comparisons). Combined biopsy led to cancer diagnoses in 208 more men (9.9%) than with either method alone and to upgrading to a higher grade group in 458 men (21.8%). However, if only MRI-target biopsies had been performed, 8.8% of clinically significant cancers (grade group ≥3) would have been misclassified. Among the 404 men who underwent subsequent radical prostatectomy, combined biopsy was associated with the fewest upgrades to grade group 3 or higher on histopathological analysis of surgical specimens (3.5%), as compared with MRI-targeted biopsy (8.7%) and systematic biopsy (16.8%). CONCLUSIONS: Among patients with MRI-visible lesions, combined biopsy led to more detection of all prostate cancers. However, MRI-targeted biopsy alone underestimated the histologic grade of some tumors. After radical prostatectomy, upgrades to grade group 3 or higher on histopathological analysis were substantially lower after combined biopsy. (Funded by the National Institutes of Health and others; Trio Study ClinicalTrials.gov number, NCT00102544.).
背景：采用 12 针系统前列腺活检与诊断不准确相关，这导致前列腺癌的过度诊断和漏诊。通过磁共振成像（MRI）靶向进行的活检可能会减少 MRI 可见病变男性中前列腺癌的分类错误。
方法：MRI 可见前列腺病变的男性接受了 MRI 靶向和系统活检。主要结局是根据分级组（即，Gleason 分级的聚类）检测癌症。分级组 1 表示临床意义不大的疾病；分级组 2 或更高，具有良好的中间风险或更差的癌症；以及分级组 3 或更高，具有不利的中间风险或更差的癌症。在接受后续根治性前列腺切除术的男性中，记录了从活检到手术标本全载玻片组织病理学分析的分级组的升级和降级。次要结局是检测分级组 2 或更高和分级组 3 或更高的癌症，根据以前的活检情况分层检测癌症，以及活检和根治性前列腺切除术之间的分级重新分类。
结果：共有 2103 名男性接受了两种活检方法；通过两种方法（联合活检）联合诊断出 1312 名（62.4%）癌症患者，404 名（19.2%）接受了根治性前列腺切除术。MRI 靶向活检的癌症检出率明显低于系统活检的分级组 1 癌症，而分级组 3 至 5 的癌症检出率明显更高（所有比较均 P<0.01）。与单独使用任何一种方法相比，联合活检使 208 名男性（9.9%）的癌症诊断增加，并使 458 名男性（21.8%）的肿瘤分级升高到更高的分级组。然而，如果只进行 MRI 靶向活检，则会将 8.8%的临床显著癌症（分级组≥3）误诊。在随后接受根治性前列腺切除术的 404 名男性中，与 MRI 靶向活检（8.7%）和系统活检（16.8%）相比，联合活检在手术标本的组织病理学分析中导致 3 级或更高分级的升级最少（3.5%）。
结论：在 MRI 可见病变的患者中，联合活检可提高所有前列腺癌的检出率。然而，单独进行 MRI 靶向活检会低估某些肿瘤的组织学分级。在根治性前列腺切除术后，组织病理学分析中 3 级或更高分级的升级在联合活检后大大降低。（由美国国立卫生研究院等资助；Trio 研究 ClinicalTrials.gov 编号，NCT00102544.）。
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