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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.3841

摘要内容如下：

重要性

前列腺特异性抗原（PSA）筛查具有降低前列腺癌死亡率的潜力，但经常检测到临床上并不重要的前列腺癌。

目的

描述在受邀参加前列腺癌筛查方案（包括PSA检测、4-激肽释放酶组和磁共振成像（MRI）扫描）的男性中发现的低级别（1级组）和高级别（2-5级组）前列腺癌的发生率。

设计、设置和参与者

ProScreen试验是在芬兰赫尔辛基和坦佩雷进行的一项临床试验，在2018年2月至2020年7月期间，以1:3的比例将61193名年龄在50岁至63岁之间未患前列腺癌的男性随机分为受邀或不受邀接受前列腺癌筛查的两组。

干预措施

随机参与干预的男性接受了PSA检测。PSA水平为3.0 ng/mL或更高的患者接受了额外的高级别前列腺癌检测，并进行了4-激肽释放酶小组风险评分。激肽释放酶小组评分为7.5%或更高的患者接受了前列腺MRI检查，随后对前列腺MRI检查结果异常的患者进行了靶向活检。最终数据收集截止到2023年6月31日。

主要成果和措施

在描述性探索性分析中，比较了接受前列腺癌筛查组和对照组在第一轮筛查后低级别和高级别前列腺癌的累积发病率。

结果

在60745名符合条件的男性（平均[SD]年龄为57.2[4.0]岁）中，15201名被随机邀请接受前列腺癌筛查，45544名未被随机邀请接受前列腺癌筛查。在15201名被邀请接受筛查的合格男性中，有7744人（51%）参与了筛查。其中，32例低度前列腺癌（累积发病率，0.41%）和128例高度前列腺癌（累积发病率，1.65%）被检出，1例癌症分级组结果缺失。在拒绝参与的7457名受邀男性（49%）中，检测到7例低度前列腺癌（累积发病率，0.1%）和44例高度前列腺癌（累积发病率，0.6%），7个癌症分级组缺失。在整个受邀筛查组中，共检测出39例低度前列腺癌（累积发病率为0.26%）和172例高度前列腺癌（累积发病率为1.13%）。在中位数为3.2年的随访期间，在未被邀请接受筛查的组中，检测到65例低级别前列腺癌（累积发病率，0.14%）和282例高级别前列腺癌（累积发病率，0.62%）。随机接受筛查邀请的整个组与对照组相比，低级别癌症的风险差异为0.11%（95%CI，0.03%-0.20%），高级别癌症的风险差异为0.51%（95%CI，0.33%-0.70%）。

结论和相关性

在这份来自一项正在进行的随机临床试验的初步描述性报告中，与未被邀请接受筛查的患者相比，在被随机邀请接受单次前列腺癌筛查干预的患者中，每196名男性中检测到1例高级别癌症，每909名男性中检测到1例低级别癌症。在研究的主要死亡率结果出来之前，应谨慎解释单轮筛查的这些初步结果。

试用注册

ClinicalTrials.gov标识符：NCT03423303。

英文原文如下：

Abstracts

Importance  Prostate-specific antigen (PSA) screening has potential to reduce prostate cancer mortality but frequently detects prostate cancer that is not clinically important.

Objective  To describe rates of low-grade (grade group 1) and high-grade (grade groups 2-5) prostate cancer identified among men invited to participate in a prostate cancer screening protocol consisting of a PSA test, a 4-kallikrein panel, and a magnetic resonance imaging (MRI) scan.

Design, Setting, and Participants  The ProScreen trial is a clinical trial conducted in Helsinki and Tampere, Finland, that randomized 61 193 men aged 50 through 63 years who were free of prostate cancer in a 1:3 ratio to either be invited or not be invited to undergo screening for prostate cancer between February 2018 and July 2020.

Interventions  Participating men randomized to the intervention underwent PSA testing. Those with a PSA level of 3.0 ng/mL or higher underwent additional testing for high-grade prostate cancer with a 4-kallikrein panel risk score. Those with a kallikrein panel score of 7.5% or higher underwent an MRI of the prostate gland, followed by targeted biopsies for those with abnormal prostate gland MRI findings. Final data collection occurred through June 31, 2023.

Main Outcomes and Measures  In descriptive exploratory analyses, the cumulative incidence of low-grade and high-grade prostate cancer after the first screening round were compared between the group invited to undergo prostate cancer screening and the control group.

Results  Of 60 745 eligible men (mean [SD] age, 57.2 [4.0] years), 15 201 were randomized to be invited and 45 544 were randomized not to be invited to undergo prostate cancer screening. Of 15 201 eligible males invited to undergo screening, 7744 (51%) participated. Among them, 32 low-grade prostate cancers (cumulative incidence, 0.41%) and 128 high-grade prostate cancers (cumulative incidence, 1.65%) were detected, with 1 cancer grade group result missing. Among the 7457 invited men (49%) who refused participation, 7 low-grade prostate cancers (cumulative incidence, 0.1%) and 44 high-grade prostate cancers (cumulative incidence, 0.6%) were detected, with 7 cancer grade groups missing. For the entire invited screening group, 39 low-grade prostate cancers (cumulative incidence, 0.26%) and 172 high-grade prostate cancers (cumulative incidence, 1.13%) were detected. During a median follow-up of 3.2 years, in the group not invited to undergo screening, 65 low-grade prostate cancers (cumulative incidence, 0.14%) and 282 high-grade prostate cancers (cumulative incidence, 0.62%) were detected. The risk difference for the entire group randomized to the screening invitation vs the control group was 0.11% (95% CI, 0.03%-0.20%) for low-grade and 0.51% (95% CI, 0.33%-0.70%) for high-grade cancer.

Conclusions and Relevance  In this preliminary descriptive report from an ongoing randomized clinical trial, 1 additional high-grade cancer per 196 men and 1 low-grade cancer per 909 men were detected among those randomized to be invited to undergo a single prostate cancer screening intervention compared with those not invited to undergo screening. These preliminary findings from a single round of screening should be interpreted cautiously, pending results of the study's primary mortality outcome.

Trial Registration  ClinicalTrials.gov Identifier: NCT03423303.

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