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Early and Accurate Detection of Prostate Cancer in General Practice

NCT03431753 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2021-05-04

No results posted yet for this study

Summary

Prostate cancer (PC) is the most common malignancy (4500 new cases/year) and the second leading cause of cancer-associated mortality (1200 deaths/year) among men in Denmark. PC is generally diagnosed on the basis of an elevated prostate specific antigen blood test followed by transrectal ultrasound (TRUS)-guided prostate biopsy.

This study aims to test early detection of PC in general practice, using the STHLM3 model with superior specificity and sensitivity for clinically significant PC, combined with multiparametric magnetic resonance imaging (mpMRI) of the prostate and MR guided biopsy.

Conditions

Interventions

DIAGNOSTIC_TEST

PSA, STHLM3 and mpMRI for PC detection

Men who request a prostate specific antigen test from their general practitioner will be offered study participation. Men with increased PC risk as judged from the STHLM3 test and/or an elevated PSA test will be offered an mpMRI examination.

Sponsors & Collaborators

  • Regional Hospital Holstebro

    collaborator OTHER

  • University of Aarhus

    collaborator OTHER

  • Central Denmark Region

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Bodil G. Pedersen, MD, PhD · Department of Radiology, Aarhus University Hospital

  • Karina D. Sørensen, Professor · Dept. of Molecular Medicine (MOMA) at Aarhus University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Denmark

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03431753 on ClinicalTrials.gov