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.
Study Type
OBSERVATIONAL
Enrollment
2,500
Aarhus University Hospital
Aarhus N, Aarhus, Denmark
RECRUITINGHerlev & Gentofte University Hospital
Hellerup, Denmark
NOT_YET_RECRUITINGOdense University Hospital
Odense, Denmark
NOT_YET_RECRUITINGNumber of MRI scans used to detect clinically significant PCs.
Compare the total number of MRI scans required to detect clinically significant PC in the study population for the uCaP score vs. PSA or a combination of uCaP+PSA vs. PSA alone.
Time frame: At recruitment completion, at year 3 in 2025
Clinically significant PC diagnoses compared to benign biopsies.
Compare the number of patients diagnosed with clinically significant PC compared to the number of patients with benign biopsies (no cancer; i.e. unnecessary biopsy) for the uCaP score vs. PSA or a combination of uCaP+PSA vs. PSA alone.
Time frame: At recruitment completion, at year 3 in 2025
Clinically significant PC diagnoses compared to clinically insignificant PC diagnoses.
Compare the number of men diagnosed with clinically significant PC with the number of men diagnosed with clinically insignificant PC (i.e. overdiagnosed) for the uCaP score vs. PSA or a combination of uCaP+PSA vs. PSA alone.
Time frame: At recruitment completion, at year 3 in 2025
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