Danish Prostate Cancer Consortium Study-1

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–99 year

Sex eligibility

Male

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus N, Aarhus, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Number of MRI scans used to detect clinically significant PCs.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Borre

CONTACT

[email protected]

+4578452616

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

Herlev and Gentofte Hospital
Odense University Hospital
University of Aarhus

Registry information

Official study title

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

Acronym: DPCC-1

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2040
First posted: Mar 14, 2023
Registry last updated: Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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