MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis.
MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis.
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DOI：
10.1056/nejmoa1801993
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发表时间：
2018-05-10
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多参数磁共振成像（MRI），有或没有靶向活检，是一种替代标准的经直肠超声引导活检前列腺癌检测的男性与前列腺特异性抗原水平升高，谁没有经历过活检。然而，比较证据有限。在一项多中心、随机、非劣效性试验中，我们将既往未接受活检的临床疑似前列腺癌的男性分配接受MRI，伴或不伴靶向活检，或标准经直肠超声引导活检。如果MRI提示前列腺癌，MRI靶向活检组的男性接受靶向活检（无标准活检芯）; MRI结果未提示前列腺癌的男性不接受活检。标准活检是10-12芯，经直肠超声引导活检。主要结果是接受临床显著癌症诊断的男性比例。次要结果包括被诊断为临床上无意义的癌症的男性比例。共有500名男性接受随机化。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，因此他们没有接受活检。MRI靶向活检组中有95名男性（38%）被检测到具有临床意义的癌症，而标准活检组中有64/248（26%）被检测到具有临床意义的癌症（校正差异，12个百分点; 95%置信区间[CI]，4 - 20; P = 0.005）。MRI（有或无靶向活检）不劣于标准活检，95%置信区间表明该策略优于标准活检。与标准活检组相比，MRI靶向活检组中较少的男性被诊断为临床上不显著的癌症（校正差异，-13个百分点; 95%CI，-19至-7; P<0.001）。在既往未接受过活检的前列腺癌临床风险男性中，活检前使用MRI进行风险评估和MRI靶向活检上级标准经直肠超声引导活检。（由国家健康研究所和欧洲泌尿外科研究基金会协会资助; PRECISION ClinicalTrials.gov编号，NCT 02380027。
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. 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. 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). 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.)