An observational study in Prostate Cancers, sponsored by Gold Standard Phantoms. 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 Gold Standard Phantoms · Observational
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 66 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Gold Standard Phantoms as lead sponsor.
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Male participants with suspected prostate cancer residing in the London area.
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.
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.
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.
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.
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.
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.
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.
Time frame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
Assessment of Reproducibility Between MRI Scanners
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
Time frame: 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.
Plan to share: No — The data generated is going to be used for optimising development of Software as a Medical Device and for assessment of reproducibility.
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