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NCT05767307Recruiting

Danish Prostate Cancer Consortium Study-1

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

Source: ClinicalTrials.gov · Last updated 29 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2500 (estimated)
First submitted
8 Feb 2023
Start date
1 Aug 2022
Primary completion date
31 Dec 2025
Lead sponsor
Aarhus University Hospital
NCT number
NCT05767307

What you commit to

  • Study type: Observational
  • Planned participants: 2500
  • From 1 Aug 2022 to the primary completion date, 31 Dec 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously diagnosed with PC or other urogenital cancers.

Lab values

  • Blood PSA levels \> 20 μg/l.

Other

  • Has one or more contraindications for MRI.
  • Have had gender reassignment treatment.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 99 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aarhus University Hospital
Coordinator of this site? Confirm its status
Aarhus NDenmarkRecruiting
Herlev & Gentofte University Hospital
Coordinator of this site? Confirm its status
HellerupDenmarkNot yet recruiting
Odense University Hospital
Coordinator of this site? Confirm its status
OdenseDenmarkNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.