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The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

This study is not yet open for participant recruitment.
Verified November 2012 by University of Aarhus
Sponsor:
Collaborators:
The Danish Medical Research Council
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01739062
First received: November 27, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Prostate Cancer
 Genetic: Genetic risk assessment

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 1298
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739062

Contacts
Contact: Pia Kirkegaard, PhD 87168295 ext 0045 pia.kirkegaard@alm.au.dk

Locations
Denmark
The Research Unit for General Practice Not yet recruiting
Aarhus, Denmark, 8000
Contact: Pia Kirkegaard, PhD     87168295 ext 0045     pia.kirkegaard@alm.au.dk    
Principal Investigator: Pia Kirkegaard, PhD, MA            
Sponsors and Collaborators
University of Aarhus
The Danish Medical Research Council
Aarhus University Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01739062     History of Changes
Other Study ID Numbers: 2011-41-6904
Study First Received: November 27, 2012
Last Updated: November 27, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
PSA test
Prostate cancer
Genetic screening

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013