Advanced diffusion magnetic reSonance prostate imaging for reducing extraneous biopsies (ASPIRE) - calibration component (Multi-centre scanner calibration) and validation component (Multi-centre validation)

In 2019 the UK National Institute for Health and Care Excellence (NICE) updated its guidelines to recommend Magnetic Resonance Imaging (MRI) for all patients prior to biopsy as it permits the targeted sampling of suspicious lesions rather than blind systematic biopsy, thereby improving detection of clinically significant prostate cancer while avoiding some unnecessary biopsies. However, there is still the major clinical problem of patients who have an 'MRI suspicious' lesion ultimately having no clinically significant cancer on biopsy. It was calculated that even by using MRI, up to 50% of prostate biopsies may be unnecessary. Prostate biopsies carry many risks and burdens for patients so reducing unnecessary biopsies is therefore a critical unmet need in prostate cancer diagnostics. The ASPIRE study has been designed to enable the safe implementation of advanced diffusion MRI into the prostate cancer diagnostic pathway. This study will compare 3 different advanced diffusion MRI sequences, Vascular, Extracellular, and Restricted Diffusion for Cytometry in Tumours (VERDICT), fast-VERDICT or Restriction Spectrum Imaging (RSI) to discover which one is superior in identifying patients who can safely avoid a biopsy. The study is also separated into 3 distinct components. Firstly, there is an optional component which, once these advanced diffusion sequences have been programmed onto MRI scanners, will recruit local volunteers who were already planning to have to routine MRI as a quality assurance measure. Component 1 (Calibration) is concerned with calibrating the same participants scans over more than one site to enable direct comparison of measurements. Patients under active follow up or previously diagnosed cancer should be enrolled in this component. Component 2 (Validation) sees a participant receiving a standard MRI scan as well as the new advanced diffusion sequences to evaluate the new tests against the reference standard without altering the standard-of-care management.