CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT02689271
• Lead Sponsor: University College, London

Brief Summary

To enable the paradigm of mp-MRI before biopsy in all patients with suspected prostate cancer by better selecting patients who will benefit from diagnostic MRI and by improving the performance of the mp-MRI itself

Detailed Description

Patients will undergo an advanced diffusion-weighted MRI sequence called VERDICT with the intention of better characterising prostate cancer. A panel of serum and urine biomarkers will also be analysed, which we hope will predict those patients who go on have a positive MRI.

OBJECTIVES:

* To establish a fluidic marker - prostate MRI paradigm which: (i) utilises fluidic markers to rationalise selection of patients with significant prostate cancer; and (ii) improves the diagnostic accuracy of imaging over and above standard multiparametric (mp) MRI

* Enable a pathway for rapid clinical evaluation of emerging fluidic markers and exosomes

* Assess the repeatability of VERDICT MRI

* Ascertain whether VERDICT derived quantitative parameters correlate with quantitative histological parameters

* Develop a database of fluidic marker and VERDICT characterised, mp-MRI, histologically validated patients for subsequent exploratory and longitudinal outcome analysis

Study Timeline

• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-23
• Study Start: 2016-04
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 365

Inclusion Criteria

• Men referred to University College London Hospital (UCLH) for prostate mp-MRI following biopsy elsewhere and biopsy naive men presenting to UCLH with a clinical suspicion of prostate cancer.

Exclusion Criteria

• Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI
• Men unable to given informed consent
• Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer
• On-going hormonal treatment for prostate cancer
• Previous biopsy within 6 months of scheduled mp-MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of VERDICT MRI	3 - 6 months (after targeted biopsy or follow up MRI)	Radiological assessment with added VERDICT MRI improves the specificity of mp-MRI for detection of significant prostate cancer by \>10% above standard multi-parametric MRI alone.

Trial Locations

Locations (1)

University College London Hospital; 🇬🇧 Camden, United Kingdom