Prostate Cancer
Conditions
Keywords
PSA test, Prostate cancer, Genetic screening
Brief summary
The preferred method for early detection of prostate cancer (PCa) in older men with family history is the Prostate Specific Antigen test (PSA test), although the method is imprecise. It produces a high number of false-positive results and increases the risk of over-diagnosis and over-treatment. Yet, an increasing number of men get the PSA test as part of unsystematic screening. Genetic risk assessment may be a better way to identify men with low risk of PCa. The main study hypothesis is that genetic information about low risk of PCa can reduce the number of patients who get a PSA test as part of unsystematic screening.
Interventions
GENETICGenetic risk assessment
Sponsors
Velux Fonden
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* patients who receive a PSA test
Exclusion criteria
* age over 80 years * elevated PSA-level (\> 4,0 ng/ml) concurrently or within previous 2 years * prostate or bladder disease * prostate cancer * non-Caucasians * do not speak and understand Danish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of low risk patients who get a PSA test | 1 year, 2 years | The primary objective of this study is to evaluate the impact on use of PSA tests of introducing genetic PCa risk assessment in general practice. |
Countries
Denmark
Outcome results
None listed