评估前列腺癌遗传风险对初级保健中 PSA 检测应用的影响：一项聚类随机对照试验。
The effect of assessing genetic risk of prostate cancer on the use of PSA tests in primary care: A cluster randomized controlled trial.
机构信息
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Department of Molecular Medicine, Aarhus University Hospital, Aarhus, Denmark.
出版信息
PLoS Med. 2020 Feb 7;17(2):e1003033. doi: 10.1371/journal.pmed.1003033. eCollection 2020 Feb.
BACKGROUND
Assessing genetic lifetime risk for prostate cancer has been proposed as a means of risk stratification to identify those for whom prostate-specific antigen (PSA) testing is likely to be most valuable. This project aimed to test the effect of introducing a genetic test for lifetime risk of prostate cancer in general practice on future PSA testing.
METHODS AND FINDINGS
We performed a cluster randomized controlled trial with randomization at the level of general practices (73 in each of two arms) in the Central Region (Region Midtjylland) of Denmark. In intervention practices, men were offered a genetic test (based on genotyping of 33 risk-associated single nucleotide polymorphisms) in addition to the standard PSA test that informed them about lifetime genetic risk of prostate cancer and distinguished between "normal" and "high" risk. The primary outcome was the proportion of men having a repeated PSA test within 2 years. A multilevel logistic regression model was used to test the association. After applying the exclusion criteria, 3,558 men were recruited in intervention practices, with 1,235 (34.7%) receiving the genetic test, and 4,242 men were recruited in control practices. Men with high genetic risk had a higher propensity for repeated PSA testing within 2 years than men with normal genetic risk (odds ratio [OR] = 8.94, p < 0.01). The study was conducted in routine practice and had some selection bias, which is evidenced by the relatively large proportion of younger and higher income participants taking the genetic test.
CONCLUSIONS
Providing general practitioners (GPs) with access to a genetic test to assess lifetime risk of prostate cancer did not reduce the overall number of future PSA tests. However, among men who had a genetic test, knowledge of genetic risk significantly influenced future PSA testing.
TRIAL REGISTRATION
This study is registered with ClinicalTrials.gov, number NCT01739062.
背景
评估前列腺癌的遗传终身风险被认为是一种风险分层的方法，以确定哪些人最有可能从前列腺特异性抗原（PSA）检测中获益。本项目旨在测试在一般实践中引入前列腺癌遗传终身风险检测对未来 PSA 检测的影响。
方法和发现
我们在丹麦中地区（米德兰大区）进行了一项以一般实践为单位（每个组 73 个）的集群随机对照试验。在干预实践中，除了标准的 PSA 检测外，男性还可以选择进行遗传检测（基于 33 个风险相关单核苷酸多态性的基因分型），该检测可告知他们前列腺癌的遗传终身风险，并区分“正常”和“高”风险。主要结果是在 2 年内重复进行 PSA 检测的男性比例。使用多水平逻辑回归模型来测试相关性。在应用排除标准后，在干预组招募了 3558 名男性，其中 1235 名（34.7%）接受了遗传检测，在对照组招募了 4242 名男性。具有高遗传风险的男性在 2 年内重复进行 PSA 检测的可能性高于具有正常遗传风险的男性（比值比[OR] = 8.94，p < 0.01）。该研究是在常规实践中进行的，存在一定的选择偏倚，这表现在接受遗传检测的参与者中，年轻和高收入的比例相对较大。
结论
为全科医生提供评估前列腺癌遗传终身风险的检测服务并没有减少未来 PSA 检测的总数。然而，在接受了遗传检测的男性中，遗传风险的知识显著影响了未来的 PSA 检测。
试验注册
本研究在 ClinicalTrials.gov 注册，编号为 NCT01739062。
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