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Danish Prostate Cancer Consortium Study-1

NCT ID: NCT05767307

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2040-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus N, Aarhus, Denmark

Site Status RECRUITING

Herlev & Gentofte University Hospital

Hellerup, , Denmark

Site Status NOT_YET_RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status NOT_YET_RECRUITING

Countries

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Denmark

Central Contacts

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Michael Borre

Role: CONTACT

[email protected]
+4578452616

Facility Contacts

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Michael Borre

Role: primary

[email protected]
+4578452616

Karina D Sørensen

Role: backup

[email protected]
+4578455316

Lars P Boesen

Role: primary

[email protected]
+45 38681041

Mads HA Poulsen

Role: primary

[email protected]
+45 21765418

References

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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.

Reference Type DERIVED
PMID: 37940151 (View on PubMed)

Other Identifiers

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1-10-72-85-22

Identifier Type: -

Identifier Source: org_study_id