Danish Prostate Cancer Consortium Study-1

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT05767307
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-12-31
• Study Completion: 2040-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 2500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (3)

Aarhus University Hospital; 🇩🇰 Aarhus N, Aarhus, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Herlev & Gentofte University Hospital; 🇩🇰 Hellerup, Denmark