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Clinical Trials in Denmark / NCT05767307
Recruiting Observational

Danish Prostate Cancer Consortium Study-1

NCT05767307 · tracked via the Priya Life Science Denmark tracker
Sponsor
Aarhus University Hospital
Phase
Observational
Started
2022-08-01
Last updated
2023-11-29

Condition(s) studied

Prostate Cancer

Study 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

Sex
MALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of MRI scans used to detect clinically significant PCs. — At recruitment completion, at year 3 in 2025
    Compare the total number of MRI scans required to detect clinically significant PC in the study population for the uCaP score vs. PSA or a combination of uCaP+PSA vs. PSA alone.
  • Clinically significant PC diagnoses compared to benign biopsies. — At recruitment completion, at year 3 in 2025
    Compare the number of patients diagnosed with clinically significant PC compared to the number of patients with benign biopsies (no cancer; i.e. unnecessary biopsy) for the uCaP score vs. PSA or a combination of uCaP+PSA vs. PSA alone.
  • Clinically significant PC diagnoses compared to clinically insignificant PC diagnoses. — At recruitment completion, at year 3 in 2025
    Compare the number of men diagnosed with clinically significant PC with the number of men diagnosed with clinically insignificant PC (i.e. overdiagnosed) for the uCaP score vs. PSA or a combination of uCaP+PSA vs. PSA alone.

Trial sites (3)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus N Aarhus Recruiting
Herlev & Gentofte University Hospital Hellerup Denmark Not Yet Recruiting
Odense University Hospital Odense Denmark Not Yet Recruiting

More Aarhus University Hospital trials in Denmark

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The Nordic Rectal Prolapse Study Enrolling by invitation
TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort Starting soon

Other trials for the same condition

The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice Active, not recruiting
Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer Recruiting
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer Active, not recruiting
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Active, not recruiting
High Impact Training to Patients with Prostate Cancer and Bone Metastases Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05767307 on ClinicalTrials.gov ↗ ← All trials in Denmark