New urine test for prostate cancer detection
Danish Prostate Cancer Consortium Study-1 (DPCC-1): Multicenter Development of Liquid Biopsy Biomarkers for Early Detection of Prostate Cancer.
This study is testing a new urine test called uCaP to see if it can better identify men who might need an MRI for prostate cancer compared to the standard PSA test.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Male |
| Sponsor | University of Aarhus Academic / other |
| Locations | 3 sites (Aarhus N, Aarhus and 2 other locations) |
| Trial ID | NCT05767307 on ClinicalTrials.gov |
What this trial studies
This study investigates a new microRNA-based urine biomarker test, uCaP, to determine its effectiveness compared to the standard PSA test in identifying men who may need an MRI scan for prostate cancer. The study will enroll 2,500 men referred for MRI at three major hospitals in Denmark. The goal is to assess whether uCaP can improve the accuracy of identifying treatment-requiring prostate cancer, potentially reducing unnecessary procedures and overdiagnosis. By comparing the performance of uCaP against PSA, the study aims to enhance early detection of aggressive prostate cancer while minimizing overtreatment of indolent cases.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who are referred for an MRI due to suspicion of prostate cancer and can understand Danish.
Not a fit: Patients who have previously been diagnosed with prostate cancer or other urogenital cancers will not benefit from this study.
Why it matters
Potential benefit: If successful, this test could lead to more accurate prostate cancer diagnoses and reduce unnecessary medical interventions.
How similar studies have performed: Other studies have shown promise in using biomarker tests for cancer detection, but this specific approach with uCaP is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aarhus N, Aarhus and 2 other locations
- Aarhus University Hospital — Aarhus N, Aarhus, Denmark (Recruiting)
- Herlev & Gentofte University Hospital — Hellerup, Denmark (Not_yet_recruiting)
- Odense University Hospital — Odense, Denmark (Not_yet_recruiting)
Study contacts
- Study coordinator: Michael Borre
- Email: borre@clin.au.dk
- Phone: +4578452616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.