The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Prostate Cancer Risk Assessment Using Genetic Markers in General Practice|
- Number of low risk patients who get a PSA test [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Genetic risk assessment
At least 40 SNP (single nucleotide polymorphisms)increase the risk of PCa. The individual risk of PCa accumulates with the increasing number of these genetic variants. The risk is doubled if patient has familial disposition as well. In retrospective studies, non-genetic risk-prediction models were compared to risk-prediction models containing both non-genetic factors and SNPs analyses. The genetic models had a significantly higher specificity than the non-genetic models. It has been argued that genetic PCa risk assessment could reduce the inexpedient use of PSA tests, saving it for patients at high risk of PCa.
Genetic: Genetic risk assessment
Other Name: Single nucleotide polymorphism
|No Intervention: Familial disposition risk assessment|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739062
|The Research Unit for General Practice|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Pia Kirkegaard, PhD||The Research Unit for General Practice, Aarhus University, Denmark|
|Study Chair:||Flemming Bro, Professor||The Research Unit for General Practice, Aarhus University, Denmark|