Not yet recruitingOBSERVATIONAL

PRostate Cancer Enhanced Diagnosis by Calibration Technology

This research is working on a new system called the CARE® Phantom, which is designed to make MRI scans for prostate cancer more accurate and reliable. When you have an MRI, this system uses special mats placed with you and clever software to check and adjust the scanner. The goal is to get a very precise measurement from the MRI, which can help doctors understand changes in the prostate better. In this study, men who are already having an MRI for suspected prostate cancer will have their scans done using these special mats. The information gathered will help improve the CARE® Phantom system, making sure it gives consistent results and helps doctors make more informed decisions about biopsies.

At a glance

Status

Not yet recruiting

Sponsor

Gold Standard Phantoms

Enrolment target

Start

01 Sep 2025

Estimated completion

01 Dec 2026

Prostate Cancers

What is this study about?

This study is about making MRI scans for prostate cancer even better. Imagine you're taking a photo, and sometimes the colours come out a little different depending on the camera or lighting. MRI scans can be a bit like that – they need to be perfectly tuned to give the most accurate and consistent results possible.

The CARE® Phantom system is a new tool being developed to do just that for prostate MRIs. It involves placing special 'calibration mats' with you during your scan. These mats, along with clever computer software, help to fine-tune the MRI machine and the images it produces. The aim is to get a very precise measurement from the scan, called the apparent diffusion coefficient (ADC), which helps doctors spot areas that might be cancerous. By making these measurements more reliable and consistent, doctors can get a clearer picture of what's happening inside the prostate.

For this study, men who are already scheduled to have an MRI for suspected prostate cancer will have their scans done using these new calibration mats. The data from these scans will be collected and analysed. This information is crucial for the researchers to further develop and improve the CARE® Phantom system, making sure it works perfectly across different MRI machines and always provides the most accurate and dependable results possible. Ultimately, this could lead to more confident decisions about whether a biopsy is needed.

Key takeaways

This study aims to make prostate cancer MRI scans more accurate and consistent.
It uses special 'calibration mats' and software during your regular MRI.
The goal is to improve future prostate cancer detection for other patients.
Participation involves no extra visits or medications.
You must already be scheduled for an MRI for suspected prostate cancer.
Your medical care will not be affected if you choose not to participate.

Who may be eligible?

To join this study, we are looking for men who are 18 years or older and are currently being checked for prostate cancer. You would need to have already had a standard MRI scan, and that scan should have shown one or more suspicious areas (rated Likert 3 or higher).

Also, a biopsy (where a small tissue sample is taken) should be planned for you within six months of your first MRI. It's really important that you are willing and able to understand and sign a consent form, showing you agree to take part.

There are some reasons why you wouldn't be able to join. For example, if your PSA (Prostate Specific Antigen) blood test result was very high (over 20ng/ml) in the last six months, or if you've already had a prostate cancer diagnosis. Also, if you've recently had certain hormone treatments (past 3 months), or if there's any medical reason why you can't have an MRI scan, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged 18 or over?
Are you currently having tests for prostate cancer?
Have you already had a standard MRI scan for your prostate?
Did your MRI show any suspicious areas (rated Likert 3 or above)?
Do you have a prostate biopsy planned within the next 6 months?
Are you able to understand and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement will be quite straightforward. Since you are already scheduled for a standard MRI scan as part of your usual care, the study will simply involve using the special GSP Phantoms (calibration mats) during that MRI. This means your MRI scan appointment itself will be used for the study data collection. You won't need extra visits just for the research. There are no new medications involved and no additional follow-up appointments directly related to the study. The total duration of your direct involvement with the study will be the time it takes for your scheduled MRI scan.

Potential risks and benefits

The main benefit of taking part is contributing to research that could improve how prostate cancer is detected and diagnosed in the future, potentially leading to more accurate results for other patients. As you are already scheduled for an MRI, there are no additional risks beyond those associated with a standard MRI scan, as the study only involves using extra equipment during this routine procedure. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University College Hospital
Verified postcode
London, United Kingdom

Common questions

What is a 'phantom' in this study?

A 'phantom' here means a special mat or device that helps to properly set up and check the MRI scanner for accuracy. It's not a real person but a tool to make sure the scan is reliable.

Will taking part in this study change my MRI scan?

No, you will have your standard MRI scan as planned. The only difference is that the special calibration mats will be used during your scan to collect extra data for the research, without changing your actual scan procedure.

Will I get any specific results from this study?

The information collected from your scan will be used to improve the detection system for future patients. You won't receive individual results directly from this specific research part of your scan.

What is a 'Likert score'?

A Likert score is a way doctors rate how suspicious an area on an MRI scan looks. A score of 3 or higher usually means there's something that needs further investigation, such as a biopsy.

Is this system currently used in hospitals?

No, this is a new system that is still under development. This study is part of the process to test and improve it before it can be used widely in clinics.

How to find out more

Lucy Newton

lucy.newton@goldstandardphantoms.com 0044 7745627050 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.