The effect of assessing genetic risk of prostate cancer on the use of PSA tests in primary care: A cluster randomized controlled trial

Autoři: Jacob Fredsøe aff001;  Jan Koetsenruyter aff003;  Peter Vedsted aff001;  Pia Kirkegaard aff004;  Michael Væth aff005;  Adrian Edwards aff006;  Torben F. Ørntoft aff001;  Karina D. Sørensen aff001;  Flemming Bro aff003
Působiště autorů: Department of Clinical Medicine, Aarhus University, Aarhus, Denmark aff001;  Department of Molecular Medicine, Aarhus University Hospital, Aarhus, Denmark aff002;  Research Unit for General Practice, The Research Centre for Cancer Diagnosis in Primary Care (Cap), Aarhus University, Aarhus, Denmark aff003;  Department of Public Health, Randers Regional Hospital, Randers, Denmark aff004;  Department of Public Health, Section of Biostatistics, Aarhus University, Aarhus, Denmark aff005;  Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, United Kingdom aff006
Vyšlo v časopise: The effect of assessing genetic risk of prostate cancer on the use of PSA tests in primary care: A cluster randomized controlled trial. PLoS Med 17(2): e1003033. doi:10.1371/journal.pmed.1003033
Kategorie: Research Article
doi: 10.1371/journal.pmed.1003033



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.


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, number NCT01739062.

Klíčová slova:

Biopsy – Cancer detection and diagnosis – Denmark – General practitioners – Genetic testing – Human genetics – Prostate cancer – Schools


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2020 Číslo 2
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