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Advanced Diffusion Magnetic reSonance Prostate Imaging for Reducing Extraneous Biopsies (ASPIRE) - Calibration Component (Multi-centre Scanner Calibration) and Validation Component (Multi-centre Validation)

NCT07808528

Not Yet RecruitingNA

Sponsor: University College, London

Conditions: Prostate Cancer (Diagnosis)

Interventions: MRI

Countries: United Kingdom

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.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients aged ≥18 scheduled for a prostate mpMRI (Optional Component)
* Willing and able to provide written informed consent (Optional Component, Component 1 and Component 2)
* Patients aged ≥18 with a prior mpMRI demonstrating at least one definite lesion suspicious for prostate cancer (Likert or PI-RADS score 4 or 5) and either under active surveillance for previously diagnosed low-risk prostate cancer or awaiting definitive treatment (Component 1)
* Willing and able to undergo multiple MRI scans at different hospitals (Component 1)
* Patients aged ≥18 with clinical suspicion of prostate cancer, who are scheduled for or have just undergone a prostate mpMRI as part of initial diagnostic workup (Component 2)

Exclusion Criteria:

* Contraindications to MRI (Optional Component, Component 1 and Component 2)
* Inability to provide informed consent (Optional Component, Component 1 and Component 2)
* Prostate biopsy within the last 3 months (Component 1) OR prior prostate cancer diagnosis or treatment (Component 2)
* Inability to travel to partner hospital site (Component 1)
* Contraindication to biopsy (Component 2)

Locations (1)

London, United Kingdom