NCT05767307

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
163mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Aug 2022Jan 2040

Study Start

First participant enrolled

August 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
14 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2040

Expected
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.4 years

First QC Date

February 8, 2023

Last Update Submit

November 28, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hospital

Aarhus N, Aarhus, 8200, Denmark

RECRUITING

Herlev & Gentofte University Hospital

Hellerup, 2900, Denmark

NOT YET RECRUITING

Odense University Hospital

Odense, 5000, Denmark

NOT YET RECRUITING

Related Publications (1)

  • 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: 37940151DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma, serum, and buffy coat) and urine (supernatant and pellet)

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Michael Borre

CONTACT

+4578452616borre@clin.au.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 14, 2023

Study Start

August 1, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

January 1, 2040

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(3)