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Trial Title:
Danish Prostate Cancer Consortium Study-1
NCT ID:
NCT05767307
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Males 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 (HGH), and Odense University
Hospital (OUH).
Sampling method:
Non-Probability Sample
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus N
Zip:
8200
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Michael Borre
Phone:
+4578452616
Email:
borre@clin.au.dk
Contact backup:
Last name:
Karina D Sørensen
Phone:
+4578455316
Email:
kdso@clin.au.dk
Investigator:
Last name:
Michael Borre, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Karina D Sørensen, PhD
Email:
Principal Investigator
Investigator:
Last name:
Jacob Fredsøe, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Bodil Ginnerup, MD, PhD
Email:
Sub-Investigator
Facility:
Name:
Herlev & Gentofte University Hospital
Address:
City:
Hellerup
Zip:
2900
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Lars P Boesen
Phone:
+45 38681041
Email:
Lars.Ploug.Boesen@regionh.dk
Investigator:
Last name:
Lars P Boesen, MD
Email:
Principal Investigator
Investigator:
Last name:
Vibeke Løgager, MD
Email:
Sub-Investigator
Facility:
Name:
Odense University Hospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Mads HA Poulsen
Phone:
+45 21765418
Email:
mads.poulsen@rsyd.dk
Investigator:
Last name:
Mads HA Poulsen, MD, PhD
Email:
Principal Investigator
Start date:
August 1, 2022
Completion date:
January 1, 2040
Lead sponsor:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
University of Aarhus
Agency class:
Other
Collaborator:
Agency:
Odense University Hospital
Agency class:
Other
Collaborator:
Agency:
Herlev and Gentofte Hospital
Agency class:
Other
Source:
University of Aarhus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05767307
