Danish Prostate Cancer Consortium Study-1

Study Overview
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Brief Summary
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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.

Official Title
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Danish Prostate Cancer Consortium Study-1 (DPCC-1): Multicenter Development of Liquid Biopsy Biomarkers for Early Detection of Prostate Cancer.

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRI-first<br>Biopsy naïve men referred to MRI-first due to suspicion of PC (elevated PSA and/or suspect DRE) at one of the following three major urology/uroradiology centers in Denmark: Aarhus University Hospital (AUH), Herlev & Gentofte Hospital (HH), and Odense University Hospital (OUH), where MRI and targeted biopsy is already implemented in clinical use. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of MRI scans used to detect clinically significant PCs. | 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. | At recruitment completion, at year 3 in 2025 | 
| Clinically significant PC diagnoses compared to benign biopsies. | 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. | At recruitment completion, at year 3 in 2025 | 
| Clinically significant PC diagnoses compared to clinically insignificant PC diagnoses. | 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. | At recruitment completion, at year 3 in 2025 |