PRostate Cancer Enhanced Diagnosis by Calibration Technology

NCT06607783 | Not Yet Recruiting

• 3 other identifiers: GSP00110071751340447
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancers

Keywords

MRI; Calibration; Prostate Cancer; Quantitative Imaging Biomarker; Reproducibility; Data interoperability; Phantom; Apparent Diffusion Coefficient; ADC; PIRAD; Diagnosis; Biopsy

Outcome Measures

Primary Outcomes (1)

• Determination of the Reproducibility of GSP CARE Reference Phantom on Different MRI Scanners

  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 Outcomes (5)

• Assessment of Reproducibility Between MRI Scanners

  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

  From date of first participant enrolment until the date biopsy results of participants are received, assessed up to 6 months.

• Determination of Per-Lesion Diagnostic Accuracy of GSP CARE-Corrected ADC Measurements

  From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.

• Determination of the Association Between GSP CARE Reference Phantom Corrected Lesion ADC Measurements and Tumour Gleason Grade

  From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.

• Investigation of Device Usability

  From date of first participant enrolment until the date all radiographers and participants have completed a Usability Questionnaire, assessed up to 6 months.

Study Arms (1)

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

Interventions

MRI DIAGNOSTIC_TEST

Standard MRI using phantom.

Single Group Males

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gold Standard Phantoms: lead
• Bioxydyn Ltd, Manchester: collaborator
• National Cancer Imaging Translational Accelerator: collaborator
• University College London Hospitals: collaborator
• National Hospital of Neurology and Neurosurgery, Queens Square, London, UK: collaborator

Study Sites (1)

University College Hospital

London, London, WC1E 6AG, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lucy Newton

CONTACT

0044 7745627050; lucy.newton@goldstandardphantoms.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)