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The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice (ProCaRis)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Aarhus
Sponsor:
Collaborators:
Velux Fonden
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01739062
First received: November 27, 2012
Last updated: October 25, 2016
Last verified: October 2016
  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:


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: 4500
Study Start Date: February 2013
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2021 (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:   18 Years to 80 Years   (Adult, Senior)
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
  • non-Caucasians
  • do not speak and understand Danish
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739062

Contacts
Contact: AnnBritt Brandi Krog, Cand.scient.san 8716 79 15 ext 0045 abbk@ph.au.dk

Locations
Denmark
The Research Unit for General Practice Recruiting
Aarhus, Denmark, 8000
Contact: AnnBritt Brandi Krog, Cand.scient.san    8716 79 15 ext 0045    abbk@ph.au.dk   
Principal Investigator: AnnBritt Brandi Krog, Cand.scient.san         
Principal Investigator: Flemming Bro, Professor         
Principal Investigator: Peter Vedsted, Professor         
Sponsors and Collaborators
University of Aarhus
Velux Fonden
Aarhus University Hospital
Investigators
Principal Investigator: AnnBritt Brandi Krog, Cand.scient.san The Research Unit for General Practice, Aarhus University, Denmark
Study Chair: Flemming Bro, Professor The Research Unit for General Practice, Aarhus University, Denmark
Study Chair: Peter Vedsted, Professor Danish Research Centre for Cancer Diagnosis in Primary Care, Aarhus University, Denmark
  More Information

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: October 25, 2016
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 December 07, 2016