Danish Prostate Cancer Consortium Study-1 (DPCC-1)

Aarhus University Hospital

Status: Enrolling

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05767307

1-10-72-85-22

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,500 participants in 1 patient group

MRI-first

Description:

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.