Actively Recruiting
Danish Prostate Cancer Consortium Study-1
Led by Aarhus University Hospital · Updated on 2023-11-29
2500
Participants Needed
3
Research Sites
908 weeks
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
U
University of Aarhus
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Danish Prostate Cancer Consortium Study-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �318 years.
- Understand oral and written Danish.
- Referred to MRI (multi or bi-parametric) due to suspicion of prostate cancer at Aarhus University Hospital, Odense University Hospital, or Herlev Hospital.
You will not qualify if you...
- Previously diagnosed with prostate cancer or other urogenital cancers.
- Have one or more contraindications for MRI.
- Have had gender reassignment treatment.
- Blood PSA levels greater than 20 bcg/l.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Aarhus University Hospital
Aarhus N, Aarhus, Denmark, 8200
Actively Recruiting
2
Herlev & Gentofte University Hospital
Hellerup, Denmark, 2900
Not Yet Recruiting
3
Odense University Hospital
Odense, Denmark, 5000
Not Yet Recruiting
Research Team
M
Michael Borre
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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