CombIning advaNces in imagiNg With biOmarkers for improVed Diagnosis of Aggressive prosTate cancEr
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University College, London
- Enrollment
- 365
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of VERDICT MRI
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Diagnostic accuracy of VERDICT MRI
Time Frame: 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.