NCT03431753

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 21, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 4, 2021

Status Verified

October 1, 2020

Enrollment Period

4 years

First QC Date

December 21, 2017

Last Update Submit

May 3, 2021

Conditions

Prostate CancerProstate NeoplasmProstate Adenocarcinoma

Keywords

STHLM3-testprostate cancerMR-imagingMR-targeted biopsyMRINovel biomarkersGenetic screening

Outcome Measures

Primary Outcomes (1)

  • Proportion of PC suspicious lesions detected by mpMRI based on the STHLM3 test vs. the prostate specific antigen test.

    Evaluation of the proportion of patients identified with PC suspicious lesions at mpMRI based on the STHLM3 vs. the prostate specific antigen test.

    24 months

Secondary Outcomes (2)

  • Proportion of PC diagnoses detected in the study population based on the STHLM3 test vs. the prostate specific antigen test.

    24 months

  • Compare results from clinical study with current clinical practice.

    24 months

Study Arms (1)

PSA, STHLM3 and mpMRI for PC detection

EXPERIMENTAL

mpMRI, and if suspect MR-targeted prostate biopsy, in men with increased PC risk as judged from the STHLM3 test and/or an elevated prostate specific antigen test.

Diagnostic Test: PSA, STHLM3 and mpMRI for PC detection

Interventions

PSA, STHLM3 and mpMRI for PC detectionDIAGNOSTIC_TEST

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.

PSA, STHLM3 and mpMRI for PC detection

Eligibility Criteria

Age50 Years - 69 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 50-69 years
  • no previous pelvic cancer
  • no previous prostate biopsy
  • no previous elevated PSA results
  • informed consent from the participant

You may not qualify if:

  • palpable prostatae tumor by digital rectal examination
  • previously diagnosed with/or treated for an urogenital cancer disease
  • contraindications to 3 T MRI
  • known severe renal impairment with estimated glomerular filtration rate \<30 ml / min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Practice

Aarhus, Central Jutland, 8200, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Bodil G. Pedersen, MD, PhD

    Department of Radiology, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Karina D. Sørensen, Professor

    Dept. of Molecular Medicine (MOMA) at Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2017

First Posted

February 13, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 4, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)