Prostate CancersPREDICTNCT06607783
PRostate Cancer Enhanced Diagnosis by Calibration Technology
An observational study of Prostate Cancers, run by Gold Standard Phantoms at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancers
- What is being tested?
- MRI
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jun 2026to 31 Mar 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male participants with suspected prostate cancer residing in the London area.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University College Hospital
London, London, WC1E 6AG
Harbir Sidhu, 0044 7946610486, harbir.sidhu@nhs.net
About this study
Official title: 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.
- Conditions
- Prostate Cancers
- Being tested
- MRI
- Keywords
- MRI, Calibration, Prostate Cancer, Quantitative Imaging Biomarker, Reproducibility, Data interoperability, Phantom, Apparent Diffusion Coefficient, ADC, PIRAD, Diagnosis, Biopsy
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Standard MRI using phantom.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.
Investigation of Device Usability
Measured: From date of first participant enrolment until the date all radiographers and participants have completed a Usability Questionnaire, assessed up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start26 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gold Standard Phantoms
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioxydyn Ltd, Manchester, National Cancer Imaging Translational Accelerator, University College London Hospitals, National Hospital for Neurology and Neurosurgery
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607783
- Sponsor's protocol ID
- GSP001
- Other IDs
- 10071751, 340447
- Acronym
- PREDICT
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data generated is going to be used for optimising development of Software as a Medical Device and for assessment of reproducibility.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06607783
- Acronym / sponsor ID
- PREDICT / GSP001
- Conditions
- Prostate Cancers
- Keywords
- MRI, Calibration, Prostate Cancer, Quantitative Imaging Biomarker, Reproducibility, Data interoperability, Phantom, Apparent Diffusion Coefficient
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Gold Standard PhantomsIndustry (pharma, biotech, devices)
- Collaborators
- Bioxydyn Ltd, Manchester, National Cancer Imaging Translational Accelerator, University College London Hospitals, National Hospital for Neurology and Neurosurgery
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Males | – | Diagnostic Test: MRIMen with clinically suspected prostate cancer and referred for prostate MRI with Likert/PIRADS 3 or above and prior decision made to perform targeted biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male participants with suspected prostate cancer residing in the London area.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIStandard MRI using phantom. | Diagnostic test | Single Group Males |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancers, run by Gold Standard Phantoms at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucy Newton (0044 7745627050, lucy.newton@goldstandardphantoms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 4 Nov 2026.