The effect of assessing genetic risk of prostate cancer on the use of PSA tests in primary care: a cluster randomized controlled trial
Autor: | Karina Dalsgaard Sørensen, Pia Kirkegaard, Michael Vaeth, Jacob Fredsøe, Torben F. Ørntoft, Jan Koetsenruyter, Peter Vedsted, Adrian Edwards, Flemming Bro |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Male
Medical Doctors Denmark Biopsy Health Care Providers Social Sciences 030204 cardiovascular system & hematology Geographical locations law.invention Prostate cancer 0302 clinical medicine Randomized controlled trial Sociology law Medicine and Health Sciences Medicine 030212 general & internal medicine Medical Personnel Early Detection of Cancer media_common Schools medicine.diagnostic_test Prostate Cancer Prostate Diseases General Medicine Genomics Middle Aged Europe Professions Oncology Multilevel Analysis Kallikreins Risk assessment Research Article medicine.medical_specialty Randomization media_common.quotation_subject Urology Single-nucleotide polymorphism Surgical and Invasive Medical Procedures Polymorphism Single Nucleotide Risk Assessment Education 03 medical and health sciences Genomic Medicine Diagnostic Medicine General Practitioners Internal medicine Physicians Genetics Cancer Detection and Diagnosis Humans Genetic Testing European Union Genetic testing Aged Selection bias Clinical Genetics Primary Health Care business.industry Prostatic Neoplasms Biology and Life Sciences Cancers and Neoplasms Human Genetics Odds ratio Prostate-Specific Antigen medicine.disease Health Care Genitourinary Tract Tumors Logistic Models Population Groupings People and places business |
Zdroj: | PLoS Medicine PLoS Medicine, Vol 17, Iss 2, p e1003033 (2020) Fredsøe, J, Koetsenruijter, J, Vedsted, P, Kirkegaard, P, Væth, M, Edwards, A, Ørntoft, T F, Sørensen, K D & Bro, F 2020, ' The effect of assessing genetic risk of prostate cancer on the use of PSA tests in primary care : A cluster randomized controlled trial ', PLOS Medicine, vol. 17, no. 2, pp. e1003033 . https://doi.org/10.1371/journal.pmed.1003033 |
ISSN: | 1549-1277 |
DOI: | 10.1371/journal.pmed.1003033 |
Popis: | 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. Jacob Fredsø and colleagues carried out a cluster randomised trial in Denmark to assess whether having the genetic test to check for prostate cancer risk influenced the number of prostate cancer antigen (PSA) tests in future. Author summary Why was this study done? Population-based systematic screening and opportunistic screening for prostate cancer using the prostate-specific antigen (PSA) test result in overdetection and overtreatment of indolent cancers, which would not result in symptoms during the patient’s normal life span. Utilizing a genetic prostate cancer risk assessment could help increase future PSA testing in men with high lifetime risk and reduce it in men without normal lifetime risk. What did the researchers do and find? We provided a lifetime risk assessment (either high or normal risk) for prostate cancer in general practice (1,235 patients tested). We compared the proportion of patients with high/normal risk who had a repeat PSA test within 2 years with 4,242 patients (controls) who did not have the genetic test. As compared with controls, patients with a high genetic risk had a much higher chance of a repeat PSA test within 2 years (8.94 times higher), whereas patients with a normal genetic risk had a lower chance of a repeat PSA test (0.62 times lower). What do these findings mean? By providing a genetic risk assessment for prostate cancer in general practice, it was possible to change the patients’ future use of PSA testing—i.e., targeting PSA testing to the group of men with high risk while reducing opportunistic testing in men at normal risk. Longer follow-up is required to evaluate the effect of genetic risk assessment on the number of prostate cancer biopsies and diagnoses. |
Databáze: | OpenAIRE |
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