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Comparison of Diagnostic Accuracy of Luminal Index and MP MRI for Accelerated deTEction of Significant Prostate Cancer

NCT05020522 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 702

Last updated 2023-10-03

No results posted yet for this study

Summary

Multi-parametric (mp) MRI has now internationally been incorporated as standard of care in the work-up of participants with suspected prostate cancer. The standard mpMRI protocol requires 30-45 minutes to be performed and has a sensitivity and specificity of approximately 90% and 50% for the detection of clinically significant prostate cancer. Compared to the non-targeted systematic transrectal ultrasound (TRUS) biopsy approach in men with clinically suspected prostate cancer (e.g.: elevated PSA), performing mpMRI as a triage test allows to detect clinically significant cancer in more men (38% vs 26%) and clinically insignificant cancer in less men (9% vs 22%), while avoiding biopsy in roughly one third of men.

However, there is need for improvement in the prostate diagnostic pathway even after incorporation of mp-MRI, specifically mpMRI can miss significant cancer in around 10% of cases and only 50% of positive scans turn out to harbor significant cancer at biopsy. Moreover, the key functional imaging sequence of mp-MRI (i.e.: DWI) often suffers from image artifacts causing difficulty in scan interpretation.

To address these issues the investigators aim to investigate Luminal Index MRI (LI-MRI), a novel method of MR imaging that requires only up to 10 minutes to be performed and doesn't require the use of contrast media. LI-MRI has shown promising results for the characterization of prostate cancer.

In this study the diagnostic performance of LI-MRI and mpMRI for the detection of prostate cancer will be directly compared.

Conditions

Interventions

DIAGNOSTIC_TEST

Luminal Index MRI (LI-MRI)

Multiecho T2 sequence; eventual biopsy of lesion(s) detected with LI-MRI only.

DIAGNOSTIC_TEST

LI-MRI targeted prostate biopsy

Biopsy targeted to suspicious lesions detected with LI-MRI only

DIAGNOSTIC_TEST

Plasma methylation signature (ctMethSig)

Blood sample.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Shonit Punwani · University College, London

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-03-01
Completion
2025-03-01

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT05020522 on ClinicalTrials.gov