The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer

• 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

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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