Danish Prostate Cancer Consortium Study-1
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 18 years — 99 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Danish Prostate Cancer Consortium Study-1 (DPCC-1): Multicenter Development of Liquid Biopsy Biomarkers for Early Detection of Prostate Cancer.
Overview
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.
Primary outcome measures
- Number of MRI scans used to detect clinically significant PCs. [Time frame: At recruitment completion, at year 3 in 2025]
- Clinically significant PC diagnoses compared to benign biopsies. [Time frame: At recruitment completion, at year 3 in 2025]
- Clinically significant PC diagnoses compared to clinically insignificant PC diagnoses. [Time frame: At recruitment completion, at year 3 in 2025]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 3 centers
- Aarhus University Hospital — Aarhus N
- Herlev & Gentofte University Hospital — Hellerup
- Odense University Hospital — Odense
Publications
- Fredsoe J, Glud E, Boesen L, Logager V, Poulsen MH, Pedersen BG, Borre M, Sorensen KD. Danish Prostate Cancer Consortium Study 1 (DPCC-1) protocol: Multicentre prospective validation of the urine-based three-microRNA biomarker model uCaP. BMJ Open. 2023 Nov 8;13(11):e077020. doi: 10.1136/bmjopen-2023-077020. PMID 37940151
Identifiers
NCT: NCT05767307 · 1-10-72-85-22