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
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