This trial is active, not recruiting.

Condition prostate cancer
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose screening
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 risk assessment Single nucleotide polymorphism
(No Intervention)

Primary Outcomes

Number of low risk patients who get a PSA test
time frame: 1 year, 2 years

Eligibility Criteria

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

Additional Information

Official title Prostate Cancer Risk Assessment Using Genetic Markers in General Practice
Principal investigator Pia Kirkegaard, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Aarhus.