Danish Prostate Cancer Consortium Study-1

Prostate Cancer Clinical Trial

— DPCC-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767307
• Other study ID #: 1-10-72-85-22
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: January 1, 2040

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: Michael Borre
• Phone: +4578452616
• Email: borre[@]clin.au.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: January 1, 2040
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N	Aarhus
Denmark	Herlev & Gentofte University Hospital	Hellerup
Denmark	Odense University Hospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Aarhus University Hospital	Herlev and Gentofte Hospital, Odense University Hospital, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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