Prostate Cancer Screening with PSA and MRI Followed by Targeted Biopsy Only.
Prostate Cancer Screening with PSA and MRI Followed by Targeted Biopsy Only.
复制标题
DOI：
10.1056/nejmoa2209454
复制
发表时间：
2022-12-08
期刊：
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
作者：
前列腺癌筛查的负担是过度诊断率高。目前尚不清楚基于人群筛查的最合适算法。我们邀请了37，887名50至60岁的男性接受定期前列腺特异性抗原（PSA）筛查。PSA水平为3 ng/ml或更高的参与者接受了前列腺磁共振成像（MRI）;三分之一的参与者被随机分配到一个参考组，该参考组接受了系统活检以及MRI上显示的可疑病变的靶向活检。其余参与者被分配到实验组，仅接受MRI靶向活检。主要结局是临床上无意义的前列腺癌，定义为Gleason评分3+3。次要结局是临床显著的前列腺癌，定义为Gleason评分至少为3+4。还评估了安全性。在被邀请接受筛查的男性中，有17，980人（47%）参加了试验。实验组的11,986名参与者中共有66名（0.6%）被诊断为临床上无意义的前列腺癌，而5994名参与者中有72人被诊断为前列腺癌。（1.2%），相差-0.7个百分点（95%置信区间[CI]，-1.0至0.4;相对风险，0.46; 95% CI，0.33至0.64; P<0.001）。与参考组相比，实验组发生临床显著前列腺癌的相对风险为0.81（95%CI，0.60至1.1）。仅通过系统活检检测到的临床显著癌症在参考组的10名参与者中被诊断;所有病例均为中等风险，主要涉及通过积极监测管理的低体积疾病。两组中严重不良事件罕见（<0.1%）。PSA水平升高的患者避免系统性活检，而采用MRI引导的靶向活检进行筛查和早期检测，可将过度诊断的风险降低一半，但代价是延迟了一小部分患者中中度风险肿瘤的检测。（由Karin和Christer Johansson基金会和其他人资助; GÖTEBORG-2 ISRCTN注册号，ISRCTN 94604465。
Screening for prostate cancer is burdened by a high rate of overdiagnosis. The most appropriate algorithm for population-based screening is unknown. We invited 37,887 men who were 50 to 60 years of age to undergo regular prostate-specific antigen (PSA) screening. Participants with a PSA level of 3 ng per milliliter or higher underwent magnetic resonance imaging (MRI) of the prostate; one third of the participants were randomly assigned to a reference group that underwent systematic biopsy as well as targeted biopsy of suspicious lesions shown on MRI. The remaining participants were assigned to the experimental group and underwent MRI-targeted biopsy only. The primary outcome was clinically insignificant prostate cancer, defined as a Gleason score of 3+3. The secondary outcome was clinically significant prostate cancer, defined as a Gleason score of at least 3+4. Safety was also assessed. Of the men who were invited to undergo screening, 17,980 (47%) participated in the trial. A total of 66 of the 11,986 participants in the experimental group (0.6%) received a diagnosis of clinically insignificant prostate cancer, as compared with 72 of 5994 participants (1.2%) in the reference group, a difference of −0.7 percentage points (95% confidence interval [CI], −1.0 to −0.4; relative risk, 0.46; 95% CI, 0.33 to 0.64; P<0.001). The relative risk of clinically significant prostate cancer in the experimental group as compared with the reference group was 0.81 (95% CI, 0.60 to 1.1). Clinically significant cancer that was detected only by systematic biopsy was diagnosed in 10 participants in the reference group; all cases were of intermediate risk and involved mainly low-volume disease that was managed with active surveillance. Serious adverse events were rare (<0.1%) in the two groups. The avoidance of systematic biopsy in favor of MRI-directed targeted biopsy for screening and early detection in persons with elevated PSA levels reduced the risk of overdiagnosis by half at the cost of delaying detection of intermediate-risk tumors in a small proportion of patients. (Funded by Karin and Christer Johansson’s Foundation and others; GÖTEBORG-2 ISRCTN Registry number, ISRCTN94604465.)