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Clinical Trials/NCT01739062
NCT01739062
Active, Not Recruiting
N/A

Prostate Cancer Risk Assessment Using Genetic Markers in General Practice

University of Aarhus1 site in 1 country5,000 target enrollmentFebruary 2013
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University of Aarhus
Enrollment
5000
Locations
1
Primary Endpoint
Number of low risk patients who get a PSA test
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
October 30, 2031
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of low risk patients who get a PSA test

Time Frame: 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.

Study Sites (1)

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