The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice
This trial is active, not recruiting.
|Treatment||genetic risk assessment|
|Sponsor||University of Aarhus|
|Collaborator||The Danish Medical Research Council|
|Start date||February 2013|
|End date||June 2017|
|Trial size||1298 participants|
|Trial identifier||NCT01739062, 2011-41-6904|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Number of low risk patients who get a PSA test
time frame: 1 year, 2 years
Male participants from 45 years up to 80 years old.
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
|Official title||Prostate Cancer Risk Assessment Using Genetic Markers in General Practice|
|Principal investigator||Pia Kirkegaard, PhD|
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