Danish Prostate Cancer Consortium Study-1

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.

NCT Number	NCT05767307
Lead Sponsor	Aarhus University Hospital Collaborators: University of Aarhus, Odense University Hospital, Herlev and Gentofte Hospital
Conditions	Prostate Cancer
Enrollment	2,500 participants
Start Date	2022-08-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2040-01-01 (estimated)
Updated on ClinicalTrials.gov	2023-11-29