Danish Prostate Cancer Consortium Study-1
Recruiting · NCT05767307 · Observational (researchers observe without assigning treatment) · Lead sponsor: Aarhus University Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Age ≥ 18 years.
- Understand oral and written Danish.
- Referred to MRI (multi or bi-parametric) due to suspicion of PC at AUH, OUH, or HGH.
Exclusion criteria
- Previously diagnosed with PC or other urogenital cancers.
- Has one or more contraindications for MRI.
- Have had gender reassignment treatment.
- Blood PSA levels \> 20 μg/l.
Where it is running
3 locations listed.
- Herlev & Gentofte University Hospital - Hellerup, Denmark
- Odense University Hospital - Odense, Denmark
- Aarhus University Hospital - Aarhus N, Aarhus, Denmark