NCT05767307 Danish Prostate Cancer Consortium Study-1
| NCT ID | NCT05767307 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aarhus University Hospital |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2022-08-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05767307 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 99 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05767307 currently recruiting?
Yes, NCT05767307 is actively recruiting participants. Contact the research team at borre@clin.au.dk for enrollment information.
Where is the NCT05767307 trial being conducted?
This trial is being conducted at Aarhus N, Denmark, Hellerup, Denmark, Odense, Denmark.
Who is sponsoring the NCT05767307 clinical trial?
NCT05767307 is sponsored by Aarhus University Hospital. The trial plans to enroll 2,500 participants.
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