MRI 靶向或标准活检用于前列腺癌诊断。
MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis.
机构信息
From University College London (UCL) and UCL Hospitals NHS Foundation Trust (V.K., C.A., F.G., A.F., S.M., S.P., M.E., C.M.M.), London North West Healthcare NHS Trust (G.H.), Whittington Health NHS Trust (M.G.), Royal Free London NHS Foundation Trust (P.B.S.), and UCL Surgical and Interventional Trials Unit (N.R.W., C.B.-G.), London, Hampshire Hospitals NHS Foundation Trust, Basingstoke (R.G.H.), Princess Alexandra Hospital NHS Trust, Harlow (J.V.), and the Institute of Applied Health Research and the NIHR Birmingham Biomedical Research Centre, University of Birmingham, Birmingham (J.D., Y.T.) - all in the United Kingdom; Helsinki University and Helsinki University Hospital, Helsinki (A.S.R.), and Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.H.V.) - all in Finland; Centro de Urología, Buenos Aires (M.B.); Sapienza University, Rome (V.P.), and IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, Milan (A.B.) - all in Italy; Mayo Clinic, Rochester, MN (L.A.M.); Martini Klinik, Hamburg (L.B.), University Hospital Essen, Essen (B.A.H.), and University Hospital Heidelberg, Heidelberg (B.A.H.) - all in Germany; Erasmus University Medical Center, Rotterdam (M.J.R.), and Radboud University Medical Center, Nijmegen (W.V.) - both in the Netherlands; University of Chicago, Chicago (S.E.); Université de Lille and Centre Hospitalier Universitaire Lille, Lille (A.V.), Université de Bordeaux and Bordeaux Pellegrin University Hospital, Bordeaux (G.R.), and Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud (A.R.), and Hospices Civils de Lyon of the Hôpital Edouard Herriot (S.C.), Lyon - all in France; Jewish General Hospital, Montreal (F.B.), and Sunnybrook Health Sciences Centre, Toronto (L.K.) - both in Canada; Ghent University Hospital, Ghent, Belgium (G.M.V.); University Hospital Bern, Bern, Switzerland (S.B.); Weill Cornell Medicine, New York-Presbyterian Hospital (J.C.H., D.M.), and New York University Langone Medical Center (S.S.T.), New York; National Institutes of Health, Bethesda, MD (P.P.); and the University of Southern California Institute of Urology, Keck School of Medicine, Los Angeles (I.G.).
出版信息
N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
BACKGROUND
Multiparametric magnetic resonance imaging (MRI), with or without targeted biopsy, is an alternative to standard transrectal ultrasonography-guided biopsy for prostate-cancer detection in men with a raised prostate-specific antigen level who have not undergone biopsy. However, comparative evidence is limited.
METHODS
In a multicenter, randomized, noninferiority trial, we assigned men with a clinical suspicion of prostate cancer who had not undergone biopsy previously to undergo MRI, with or without targeted biopsy, or standard transrectal ultrasonography-guided biopsy. Men in the MRI-targeted biopsy group underwent a targeted biopsy (without standard biopsy cores) if the MRI was suggestive of prostate cancer; men whose MRI results were not suggestive of prostate cancer were not offered biopsy. Standard biopsy was a 10-to-12-core, transrectal ultrasonography-guided biopsy. The primary outcome was the proportion of men who received a diagnosis of clinically significant cancer. Secondary outcomes included the proportion of men who received a diagnosis of clinically insignificant cancer.
RESULTS
A total of 500 men underwent randomization. In the MRI-targeted biopsy group, 71 of 252 men (28%) had MRI results that were not suggestive of prostate cancer, so they did not undergo biopsy. Clinically significant cancer was detected in 95 men (38%) in the MRI-targeted biopsy group, as compared with 64 of 248 (26%) in the standard-biopsy group (adjusted difference, 12 percentage points; 95% confidence interval [CI], 4 to 20; P=0.005). MRI, with or without targeted biopsy, was noninferior to standard biopsy, and the 95% confidence interval indicated the superiority of this strategy over standard biopsy. Fewer men in the MRI-targeted biopsy group than in the standard-biopsy group received a diagnosis of clinically insignificant cancer (adjusted difference, -13 percentage points; 95% CI, -19 to -7; P<0.001).
CONCLUSIONS
The use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonography-guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously. (Funded by the National Institute for Health Research and the European Association of Urology Research Foundation; PRECISION ClinicalTrials.gov number, NCT02380027 .).
背景
对于未接受过活检且前列腺特异性抗原水平升高的前列腺癌高危男性患者，多参数磁共振成像（MRI）联合或不联合靶向活检可替代标准经直肠超声引导下的活检进行前列腺癌检测。然而，目前比较性证据有限。
方法
在一项多中心、随机、非劣效性试验中，我们将既往未接受过活检且临床疑似患有前列腺癌的男性患者随机分配至 MRI 联合或不联合靶向活检组或标准经直肠超声引导下活检组。如果 MRI 提示前列腺癌，MRI 靶向活检组的男性将接受靶向活检（不进行标准活检芯）；如果 MRI 结果不提示前列腺癌，则不提供活检。标准活检为 10-12 芯经直肠超声引导下活检。主要结局为接受临床显著癌症诊断的男性比例。次要结局包括接受临床非显著癌症诊断的男性比例。
结果
共有 500 名男性接受了随机分组。在 MRI 靶向活检组中，252 名男性中有 71 名（28%）的 MRI 结果不提示前列腺癌，因此未接受活检。MRI 靶向活检组中 95 名（38%）男性诊断为临床显著癌症，而标准活检组中 64 名（26%）男性诊断为临床显著癌症（调整差异，12 个百分点；95%置信区间[CI]，4 至 20；P=0.005）。MRI 联合或不联合靶向活检与标准活检相比非劣效，95%CI 表明该策略优于标准活检。MRI 靶向活检组中接受临床非显著癌症诊断的男性少于标准活检组（调整差异，-13 个百分点；95%CI，-19 至 -7；P<0.001）。
结论
在未接受过活检且患有前列腺癌高危男性中，与标准经直肠超声引导下活检相比，在活检前使用 MRI 进行风险评估和 MRI 靶向活检可提高诊断为临床显著癌症的比例。（由英国国家卫生研究院和欧洲泌尿外科学会研究基金会资助；PRECISION 临床试验。gov 编号，NCT02380027）。
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