The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Genetic: Genetic risk assessment

• Registration Number: NCT01739062
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-30
• Study Start: 2013-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-04
• Primary Completion: 2025-10-30
• Study Completion: 2031-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 5000

Inclusion Criteria

• patients who receive a PSA test

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genetic risk assessment	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.

Primary Outcome Measures

Name	Time	Method
Number of low risk patients who get a PSA test	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.

Trial Locations

Locations (1)

Department of Molecular Medicine; 🇩🇰 Aarhus N, Aarhus, Denmark