An interventional study of MRI in Prostate Cancer (Diagnosis), sponsored by University College, London. Not yet recruiting at 1 site in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University College, London · Not applicable, Interventional, and Diagnostic
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.
Overview: ASPIRE constitutes three components:
This Optional Scanner Set Up Component is not powered to test a clinical hypothesis; instead, its endpoint is the successful implementation of protocols and generation of reliable imaging at each site. As a process measure, success will be declared if the advanced sequences are operational on all scanners with adequate image quality. Men will be referred to this component based on a clinical suspicion of prostate cancer. Patients can expect 1 standard MRI scan plus all additional study sequences. The standard MRI scan can be either a bi-parametric or multiparametric MRI scan depending on the availability of the site where the scan is being performed. Patients will complete this MRI and exit the study with no follow up planned for this component.
Multi-centre Calibration Component: A technical feasibility assessment study involving NHS hospital sites equipped with 3 Tesla MRI scanners from each major MRI vendor (Philips, Siemens, GE) with potential for additional sites to represent duplicates from vendors, covering platform variations. The participating site selection captures the vendor diversity likely to be encountered in a larger trial. At each site, the VERDICT, fast VERDICT, and RSI MRI sequences will be installed and tested. This component involves a small travelling volunteer cohort design of patients who will undergo the advanced diffusion research MRI scan on two different scanners within a short timeframe. By scanning the same individuals at different sites, within a small timeframe, we are enabling direct comparison of measurements and direct calibration of the quantitative parameters can be performed. This component seeks primarily to develop methods (proof-of-concept) and is not designed to evaluate clinical outcomes.
The primary data collected in the Calibration Component are the imaging metrics (e.g., VERDICT Fractional intracellular volume (fIC) values) from each scanner for each subject. These will be analysed to derive transformation formulas that map values from one scanner to an equivalent value on another, effectively creating a calibration curve for each scanner/vendor combination. This component will also record practical aspects such as the success rate of sequence deployment, any scanner-specific issues, and qualitative image quality assessments at each site.
The Calibration Component is not powered to test a clinical hypothesis; instead, its endpoint is the successful implementation of protocols and generation of calibration equations. As a process measure, success will be declared if the advanced sequences are operational on all scanners with adequate image quality, and if the analysis of the travelling volunteer data shows a consistent relationship (correlation) between scanners. For example, preliminary data already suggest that VERDICT fIC values on a Siemens scanner are systematically lower than on a Philips scanner, but with a linear mapping that could adjust one to the other. This component will formally validate this across more subjects and across all vendor pairs.
Men will be identified based on whether they are in current active surveillance for previously diagnosed low-risk prostate cancer or awaiting definitive treatment for clinical suspicion of prostate cancer. Patients will be informed that travel as a part of this component is mandatory and should not provide full informed consent if travel is not possible for them. Participants in this cohort will have 2 scans at 2 different major vendors, one will occur at UCLH and the other at a secondary site within 2 months of the first scan. As soon as the secondary scan is completed, their participation ceases and will resume standard of care treatment.
Multi-centre Diagnostic Accuracy Validation Component: A multi-site diagnostic accuracy study with embedded technical comparison of patients undergoing initial evaluation for suspected prostate cancer at four external NHS sites to assess and compare the diagnostic performance of VERDICT, fast VERDICT, and RSI (additional research sequences) when added to standard MRI as per normal clinical protocol) in the same session. Following SoC imaging, all patients will proceed to the normal diagnostic pathway: those with MRI findings warranting biopsy (typically Prostate Imaging - Reporting and Data System (PI-RADS) or Likert score ≥3) will undergo a targeted biopsy of the identified lesion(s) and any appropriate systematic sampling as per local standard. Patients with negative MRI (score 1-2, indicating low suspicion) generally do not undergo immediate biopsy as part of standard care; these patients will be managed according to standard local practice (which may involve clinical observation and repeat Prostate-Specific Antigen (PSA) or MRI at a later date). Importantly, the results of the advanced diffusion MRI sequences will not be used to direct patient management in the Validation Component.
For the patients who undergo a biopsy, as directed by the clinical findings of their MRI scan, while the results of the biopsy will be blinded, we will know the lesions that were identified on MRI that underwent the biopsy. Using this location information, we will draw the lesion onto the VERDICT, fast-VERDICT, RSI maps to determine the diagnostic accuracy of the MRI with the additional advanced diffusion imaging (each of the three techniques independently), allowing comparison of diagnostic accuracy within the same individuals, which is referred to as a paired within subject design. Each patients MRI will be interpreted both with and without the retrospective advanced diffusion metrics. This design allows evaluation of the new tests against the reference standard without altering the standard-of-care management. It is ethically appropriate because it avoids withholding recommended biopsies or performing unnecessary ones purely for research purposes. There is no randomisation; every participant receives all imaging tests under evaluation. The interpretation of the advanced diffusion MRI results, however, will be retrospective and not influence immediate clinical management, to avoid introducing any experimental risk.
All components are prospective in that participants are enrolled going forward with data collected in real-time. The protocol will be implemented concurrently at multiple centres, leveraging each site's clinical workflow for prostate MRI and biopsy. The Calibration Component will begin concurrently to the Validation Component, and the calibration results will inform the analysis of the validation data.
After all imaging and biopsy procedures, an independent evaluation of the MRI data will be conducted at the sites as per standard-of-care. The MRI for each patient will be interpreted in two ways: (a) using standard MRI alone (using PI-RADS v2.1 or local Likert scoring for suspicion), and (b) using MRI plus each advanced method (e.g., MRI+VERDICT). For the combined interpretation, predefined criteria will be used such as: "Consider an MRI-suspicious lesion as benign (no biopsy needed) if VERDICT fIC is below threshold X" - where X may be a site-calibrated threshold corresponding to \~90% sensitivity for cancer detection. By comparing these interpretations to the biopsy-confirmed outcomes, diagnostic performance characteristics for each approach can be calculated. The primary analysis will focus on specificity (proportion of patients without significant cancer who are correctly identified as such and spared biopsy) and sensitivity (proportion of patients with significant cancer correctly identified) of the new pathway versus standard care.
All Validation Component sites will follow a common master protocol for imaging and data collection to ensure consistency. The study is not randomized; every participant effectively serves as their own control for comparing tests. The Validation Component is designed in accordance with STARD (Standards for Reporting Diagnostic Accuracy Studies) guidelines, including clearly defined index tests and reference standards, blinded interpretation, and paired analysis.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 660 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Local Volunteers who were already scheduled for a routine mpMRI who agree to having the advanced diffusion sequences added as a research scan to their planned MRI scan. The research scan will not be used to influence clinical decisions and just to see if the new advanced diffusion sequences are optimised
Procedure: MRI
Travelling volunteer study design of patients with confirmed prostate cancer who will agree to have one mpMRI with the added advanced diffusion sequences research scan at their home site of UCLH and then one more mpMRI with the added advanced diffusion sequences research scan at one of four external NHS hospital sites. These research scans will not be used to influence clinical decisions for the participant but will be used to calibrate the new sequences across different scanners at different sites.
Procedure: MRI
A prospective cohort study at four external sites for participants with suspected prostate cancer to assess and compare the diagnostic performance of VERDICT, fast VERDICT, and RSI when added to standard mpMRI. The results of the advanced diffusion MRI sequences will not be used to direct patient management in the Validation Component. Radiologists and urologists will remain blinded to the VERDICT/RSI findings when making biopsy decisions, to ensure the study does not influence or compromise care.
Procedure: MRI
The combination of the 3 additional sequences as a part of the research scan will distinguish this intervention from other studies.
Also known as: MRI + VERDICT, fast-VERDICT and RSI scan
Calibration Component Analysis: The goal is to characterise differences in quantitative MRI metrics between scanners and derive calibration adjustments. For each pair of scanners (e.g., Philips vs Siemens), a scatter plot of VERDICT fIC values (or other
Calibration Component Analysis: The goal is to characterise differences in quantitative MRI metrics between scanners and derive calibration adjustments. For each pair of scanners (e.g., Philips vs Siemens), a scatter plot of VERDICT fIC values (or other metric) will be examined across all subjects who were scanned on both. We will calculate the mean difference and 95% limits of agreement (Bland-Altman analysis) to quantify bias and variability. A linear regression will be performed, and the regression equation (slope, intercept) will be used as the calibration formula. If needed, higher-order terms or non-linear fit will be considered, but simplicity is preferred. We will also assess the repeatability of measurements on the same scanner (some participants may have had repeat scans on the same machine or two Philips sites, etc.). The outcome of Calibration Component will be reported descriptively. No formal hypothesis test is applicable, but we will note if the inter-scanner difference
Time frame: 5 years
Direct comparison between VERDICT, fast VERDICT, and RSI
For each patient, we will have three outcomes (for each advanced method combined with MRI). We will compare, for example, MRI+VERDICT vs MRI+RSI specificity by looking at the subset of patients who have discordant results (one test positive, the other negative, and no cancer or cancer accordingly) using McNemar's test. We will do this pairwise for all combinations (VERDICT vs RSI, VERDICT vs fast VERDICT, RSI vs fast VERDICT). Additionally, we may compare AUC (area under the ROC curve) for the continuous metrics from each technique. The ROC curves will be generated for VERDICT fIC, RSI index, etc., against the outcome, possibly stratified by site or vendor. An averaged (pooled data) ROC comparison will indicate overall performance differences
Time frame: 5 years
Comparison of calibrated vs uncalibrated threshold performance
This will involve looking at the sensitivity and specificity of, for example, a uniform fIC threshold of 0.41 across all sites vs using each site's calibrated equivalent threshold (e.g. 0.35 on Siemens, etc.). We will report whether calibration improved the alignment of results. A paired comparison of these two approaches in the same dataset will be conducted (each patient can be classified by both methods). We hypothesize calibration will modestly improve specificity or consistency across sites, but this needs confirmation.
Time frame: 5 years
Subgroup analyses
We will examine performance by site and by scanner vendor. For each site individually, we will replicate the primary analysis to see if VERDICT added benefit at that site (these are the "individually powered" validations - each site with \~150 patients should be powered \~80% to see a similar effect size). This will tell us if any site deviates significantly. We will also aggregate data by vendor (e.g., combine both Siemens sites' data) to see if, say, all Siemens scanners behave similarly vs others. If needed, statistical models like logistic regression with site or vendor as random effects could be used to formally test for heterogeneity, but with a minimum of four sites it may be simpler to descriptively report these results.
Time frame: 5 years
Negative MRI cohort
Although patients with a negative MRI likely won't have biopsy verification, we will track any who had follow-up MRIs or biopsies. We will calculate the observed outcome at 1 year: how many were found to have cancer later. This is not comparative, but it gives an estimate of false negatives for both standard and advanced MRI (since an advanced MRI might conceivably pick up something in an MRI-negative case; we will see if any such case occurred and what their follow-up showed).
Time frame: 5 years
Plan to share: Yes — Anonymised data will be available at request for bona fide researchers with important research questions subject to approval by the study steering committee.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will become available 1 year after publication of the main study results.
Access criteria: A study steering committee will review all requests for access to the data and will make decisions on whether or not to grant access to bona fide researchers based on the importance of the research question being asked, ensuring analysis is non overlapping with existing analyses and planned analyses.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2031, 52 months later.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 52 months is above that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
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