The ASPIRE Study (multi-site)
Research type
Research Study
Full title
Advanced diffusion magnetic reSonance Prostate Imaging for Reducing Extraneous biopsies (ASPIRE) – Calibration Component (Multi-centre Scanner Calibration), Validation Component (Multi-centre Diagnostic Accuracy Validation).
IRAS ID
348487
Contact name
Shonit Punwani
Contact email
Clinicaltrials.gov Identifier
Z6364106/2025/11/139, UCL Data Protection Registration Number
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
In 2019 the UK National Institute for Health and Care Excellence (NICE) updated its guidelines to recommend 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 (MS) 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, VERDICT, fast-VERDICT or 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 patient volunteers who were already planning to have a 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 patient receiving both 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.In total ASPIRE (MS) will recruit up to 660 participants.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
26/SC/0202
Date of REC Opinion
1 Jul 2026
REC opinion
Further Information Favourable Opinion