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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01739062
Recruitment Status : Active, not recruiting
First Posted : November 30, 2012
Last Update Posted : November 4, 2020
Velux Fonden
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Genetic: Genetic risk assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Prostate Cancer Risk Assessment Using Genetic Markers in General Practice
Actual Study Start Date : February 2013
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2031

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01739062

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Department of Molecular Medicine
Aarhus N, Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Velux Fonden
Aarhus University Hospital
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Principal Investigator: Karina D Sørensen, PhD Department of Molecular Medicine, Aarhus University Hospital, 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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Aarhus Identifier: NCT01739062    
Other Study ID Numbers: 2011-41-6904
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Keywords provided by University of Aarhus:
PSA test
Prostate cancer
Genetic screening
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases