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

University College London (UCL)

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: MRI

Study type: Observational

Funder types: Other

Identifiers

NCT02689271

15/0692

Details and patient eligibility

About

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

Full 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

Enrollment: 365 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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