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Clinical Trial Summary

The purpose of the study is to investigate if a new promising microRNA-based urine biomarker test for prostate cancer, called uCaP, is better than the current standard test (PSA) to identify men who would benefit from an MRI scan of the prostate. The study will include 2,500 men referred to MRI of the prostate at three major hospital centers in Denmark (Aarhus, Odense, and Herlev) and compare the accuracy of uCaP to PSA. Based on preliminary data it is expected that uCaP will be >20% better than PSA at identifying treatment-requiring cancer. Hence, uCaP could help to better pre-select men for MRI and thereby reduce unnecessary MRI scans, unnecessary prostate biopsies, as well as overdiagnosis and overtreatment of indolent PCs, while maintaining high sensitivity for aggressive PC that needs early detection and early treatment.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05767307
Study type Observational
Source University of Aarhus
Contact Michael Borre
Phone +4578452616
Email borre@clin.au.dk
Status Recruiting
Phase
Start date August 1, 2022
Completion date January 1, 2040

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