Danish Prostate Cancer Consortium Study-1

Recruiting now

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05767307

Run by

Aarhus University Hospital

People needed

2500

Starts

2022-08-01

Expected to finish

2040-01-01

Last updated by the study team

2023-11-29

Who can join

Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Aarhus University Hospital — Aarhus N, Aarhus, Denmark (enrolling)
• Herlev & Gentofte University Hospital — Hellerup, Denmark
• Odense University Hospital — Odense, Denmark

Full record on ClinicalTrials.gov

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