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Predicting Prostate Biopsy Results With Biomarkers and mpMRI.

NCT03730324 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2023-03-23

No results posted yet for this study

Summary

Current standard prostate biopsy techniques, used to definitively diagnose prostate cancer (PC), utilises an ultrasound guided biopsy approach, that offers unsatisfactory specificity and sensitivity for clinical significant PC. This often leads to harmful unnecessary biopsies. To improve the overall detection of clinical significant PC, multiparametric magnetic resonance imaging (mpMRI) has emerged as a new technique that might be useful in selecting the appropriate patient for biopsy. Nevertheless, mpMRI fail to detect cancer in some circumstances and the exact role of mpMRI is undetermined. Currently, the majority of PC is diagnosed either incidentally or by unsystematic screening with prostate specific antigen (PSA). PSA suffers from being an organ specific, but cancer unspecific serum biomarker. PSA testing may neither rule out or confirm the presence of prostate cancer. Newer biomarkers have shown promise in curbing some of this sensitivity and specificity gap, but still needs refinement.

In the present study, the investigators will use mpMRI and a new set of urine and plasma biomarkers in combination, prior to performing standard biopsies in order to develop a prediction model for the biopsy outcome. If proven successful the model would offer excellent risk stratification and possibly mitigating the need for biopsies.

Conditions

Interventions

DIAGNOSTIC_TEST

mpMRI

Study subjects will undergo urine and plasma biomarker testing and mpMRI prior to biopsy

DIAGNOSTIC_TEST

Urine and plasma biomarkes.

Study subjects will undergo urine and plasma biomarker testing prior to standard biopsy

Sponsors & Collaborators

  • Torben Brøchner Pedersen

    lead OTHER

Principal Investigators

  • Lars Lund, DMsc · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2021-07-01
Completion
2022-06-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

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 NCT03730324 on ClinicalTrials.gov