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

University College, London365 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

365

Conditions

Prostate Cancer

Interventions

MRIOTHER

VERDICT diffusion-weighted microstructure imaging sequence

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University College London Hospital

Camden, United Kingdom

Outcomes

Primary Outcomes

Diagnostic accuracy of VERDICT 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.

Time frame: 3 - 6 months (after targeted biopsy or follow up MRI)

Data from ClinicalTrials.gov

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