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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus N
Herlev & Gentofte University Hospital
NOT_YET_RECRUITING
Hellerup
Odense University Hospital
NOT_YET_RECRUITING
Odense
Contact Information
Primary
Michael Borre
borre@clin.au.dk
+4578452616
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2040-01-01
Participants
Target number of participants: 2500
Treatments
MRI-first
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Aarhus, Odense University Hospital, Herlev and Gentofte Hospital
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov