PRostate Cancer Enhanced Diagnosis by Calibration Technology (PREDICT)

August 22, 2025 updated by: Gold Standard Phantoms

A Multi-Centre, Pivotal Stage, Study to Determine the Between MRI Scanner Reproducibility of Gold Standard Phantom Calibrated Acquisition Replicator (CARE) for Measurement of Apparent Diffusion Coefficients in the Prostate of Patients With MR Positive Lesions Destined for Biopsy

The CARE® Phantom system is a medical device system that is being developed has been designed to enable the quantitative measurement of the apparent diffusion coefficient (ADC) in the prostate of patients undergoing a multi-parametric MRI (mpMRI) scan to detect prostate cancer. The final device system will comprise three elements: a calibration mat containing phantoms and embedded monitoring software, a docking station to transfer data from the phantoms, and software as a medical device (SaMD) for calibrating the resulting mpMRI images.

In this clinical trial, patients will undergo MRI scanning in different scanners using the GSP Phantoms to provide mpMRI images and phantom data for subsequent in silico analysis. The captured images and data will be used to further develop and calibrate the GSP prototype SaMD part of the medical device system, and to establish the degree of optimised reproducibility that can be achieved.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • London
      • London, London, United Kingdom, WC1E 6AG
        • University College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male participants with suspected prostate cancer residing in the London area.

Description

Inclusion Criteria:

  • Men aged 18 years and older undergoing investigations for PCa.
  • Standard of Care MRI conducted.
  • One or more lesions with a Likert score of 3 or above identified on clinical reports.
  • Planned targeted biopsy within 6 months from the date of clinical care MRI.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Prostate specific antigen (PSA) level > 20ng/ml within 6 months
  • Previous diagnosis of prostate cancer
  • Ongoing hormone treatment within 3 months prior to MRI, excluding antiandrogens or 5-alpha reductase inhibitors
  • Contraindication to MRI scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single Group Males
Men with clinically suspected prostate cancer and referred for prostate MRI with Likert/PIRADS 3 or above and prior decision made to perform targeted biopsy.
Diagnostic test: MRI
Standard MRI using phantom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of the Reproducibility of GSP CARE Reference Phantom on Different MRI Scanners
Time Frame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.

To determine the reproducibility of GSP CARE reference phantom corrected lesion ADC measurements when the phantom is used on different MRI scanners for measurement of ADC in prostate.

Voxel-wise median ADC values will be obtained for each lesion region of interest (ROI), referred to in the synopsis as "ADC measurements".

The study is designed for 3 pairwise comparisons of 3 MRI scanners, enabling reproducibility determination between each pair of scanners. The study is powered for each pairwise comparison, based on a single lesion per patient.
From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of Per-Lesion Diagnostic Accuracy of GSP CARE-Corrected ADC Measurements
Time Frame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
To determine per-lesion diagnostic accuracy of ADC measurements, corrected using the GSP CARE reference phantom, for significant cancer in men scheduled for standard of care biopsy with Likert/PIRADS 3 or above scored MRI lesions. Sensitivity and specificity will be calculated per lesion, with 95% confidence intervals using Wilson method. Statistical significance will be based on 95% confidence intervals.
From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
Observation of the Extent to Which Biopsy Can be Avoided when Using GSP CARE Phantom System
Time Frame: From date of first participant enrolment until the date biopsy results of participants are received, assessed up to 6 months.
To investigate the proportion of men who would receive a correct clinical recommendation that biopsy could be avoided using ADC measurements with and without GSP CARE reference phantom correction. This is a feasibility analysis to indicate data needed to power a trial to demonstrate a difference in proportion. Data will be presented graphically, with 95% confidence intervals using Wilson method. The study is not powered to show a statistical significance. Comparison of paired proportions within patient of recommendations using ADC measurements with and without GSP CARE reference phantom correction.
From date of first participant enrolment until the date biopsy results of participants are received, assessed up to 6 months.
Determination of the Association Between GSP CARE Reference Phantom Corrected Lesion ADC Measurements and Tumour Gleason Grade
Time Frame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
Investigation of Device Usability
Time Frame: From date of first participant enrolment until the date all radiographers and participants have completed a Usability Questionnaire, assessed up to 6 months.
From date of first participant enrolment until the date all radiographers and participants have completed a Usability Questionnaire, assessed up to 6 months.
Assessment of Reproducibility Between MRI Scanners
Time Frame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
To determine whether increasing the between scanner reproducibility enables sufficiently precise voxelwise median ADC measurements (i.e. variance is not inferior to a minimally acceptable variance) to be able to distinguish between the expected ADC values from clinically significant and clinically insignificant prostate lesions.
From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gold Standard Phantoms

Collaborators

University College London Hospitals
Bioxydyn Ltd, Manchester
National Cancer Imaging Translational Accelerator
National Hospital of Neurology and Neurosurgery, Queens Square, London, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSP001
  • 10071751 (Other Grant/Funding Number: Innovate UK)
  • 340447 (Other Identifier: IRAS Project ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data generated is going to be used for optimising development of Software as a Medical Device and for assessment of reproducibility.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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