A study looking at screening for prostate cancer using a new MRI scan (LIMIT PCa)
Cancer type:
Status:
Phase:
This study is looking at using a new scan called a Luminal Index MRI (LI-MRI) to test for prostate cancer before people have symptoms.
Cancer Research UK supports this study.
More about this trial
Prostate cancer is the most common cancer in men in the UK. Some trans women and non-binary people (who are born male) can also get prostate cancer.
We know from research that you have an increased risk of having prostate cancer if you are either over 50 or have a Black ethnic background.
There is no national 
programme for prostate cancer in the UK. This is because, at the moment, there isn’t a reliable test that can pick up prostate cancer that needs treatment at an early stage.
MRI scans generally work well for diagnosing prostate cancer. The scan shows areas of change in the prostate. Doctors then use the scan to take tissue samples (a ). The tissue samples are looked at under a microscope in a laboratory to see if the changes were caused by cancer or something else.
The type of MRI scan used in the NHS is usually a multiparametric MRI (mpMRI). The scan takes around 40 minutes.
Although this scan works well, some people are being diagnosed with by the time they have a scan. This means treatment is more difficult.
Researchers would like to increase the number of men diagnosed with early stage prostate cancer before they have symptoms. Because the cancer is small at this stage and has not spread, treatment is more likely to be successful.
To try and do this, researchers are looking at a new type of MRI scan to help look for early stage prostate cancer. It is called an LI-MRI. It takes around 5-10 minutes, and you don’t need an injection of a dye to help show up the prostate more clearly. You can have a LI-MRI scan in a mobile scanner in East London without having to go into hospital.
The researchers are looking at the scan results alongside:
- another MRI scan called a bp-MRI and
- PSA and PSA density levels
Prostate specific antigen (PSA) is a protein produced by both normal and cancerous prostate cells. It's normal for all men to have some PSA in their blood. A high level of PSA can be a sign of cancer. But your PSA level can also be raised in prostate conditions that are not cancer.
PSA density is the PSA number divided by the size of the prostate gland. Your doctor works out the size of your prostate gland with the MRI scan. The higher your density suggests a higher risk there is cancer in your prostate.
We know from research that PSA density may be more helpful than just a PSA level for screening.
Doctors think the LI-MRI might work better for screening for prostate cancer than the mpMRI. But they aren’t sure. They are doing this study to try and find out.
The main aims of this are to find out:
- if men are willing to have an LI-MRI as a screening test for prostate cancer
- how many men have a test result meaning they need more investigations to find out if they have prostate cancer
- how common prostate cancer is in men aged between 50-75, who have been invited to take part
- more about the costs and savings of using the LI-MRI to screen for prostate cancer
- about any mental or emotional changes for men having an LI-MRI for prostate cancer screening
- more about using PSA density in screening for prostate cancer
- if a bigger trial would be worth carrying out
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
- are male and aged between 50-75
- have not been diagnosed with prostate cancer before
- have not had treatment for prostate cancer before
Who can’t take part
You cannot join this study if you are not able to have an . This might be because:
- you have metal in a part of your body
- you have a
pacemaker - you have inner ear implants
- you have found it difficult in confined spaces in the past (claustrophobia)
Trial design
This is a feasibility study.
The study team would like 800 men to take part.
GP group
GP practices taking part send invitations at to people able to join. This is men aged 50-75 who have not had prostate cancer. The study team would like around 600 men to take part that have been invited by their GP.
Community group
The researchers are also going out into the community to find people to take part. They think this might be a good way to encourage men from Black and ethnic minority backgrounds to take part.
They are providing information about the study in several ways. This includes through:
- workplaces
- places of worship
- barbers
- WhatsApp and social media
- local radio
The study team would like around 200 men to take part that have heard about the study through their community.
Everyone taking part
Everyone taking part has:
- an LI-MRI
- a bp-MRI at the same time as the LI-MRI. This is another type of MRI scan. It takes around 10 minutes.
- a blood test to look at your PSA level which the team use to work out your PSA density
We have more information on having the tests, when you should expect your results, and what happens next in the ‘hospital visits’ part of this summary.
Samples for research
The researchers would like to collect an extra blood sample for research. They aim to use this sample to look for certain proteins () that might help with their research. They take the sample on the day of your study visit.
You don’t have to give this blood sample. You can say no and still take part in the main study.
Follow up for everyone taking part
The study team get in touch with you after 3 months and ask for your feedback on taking part in the study. They would like to find out if taking part in the study caused you any worry. You give your feedback by filling in an online questionnaire.
Up to 6 weeks after your study visit, the team might get in touch with you about having a more in-depth interview about your experience. This could be face-to-face, on video call or over the phone.
The study team ask to look at any results of scans or tests you have in the NHS if you need further investigations. Your GP or hospital team send them to the study team if you agree.
The team would like you to fill in a questionnaire 3 years after your visit. This is called long term follow up.
Hospital visits
You have either one visit to your nearest hospital that is taking part in the study (GP group). Or you have one visit to the mobile scanner (community group).
When you arrive, you fill in a safety checklist with a member of the study team. This asks about:
- any operations you’ve had
- whether you have any metal implants or other metal in your body
You fill in a questionnaire to find out about:
- your beliefs about prostate cancer
- your past medical history
You have a blood test. This is to look at your and to later find out your PSA density.
You have your LI-MRI scan. It takes around 10 minutes. You have a bp-MRI at the same time.
For the GP Group, the study visit takes around 30 minutes. For the community group, the study visit takes around 60 minutes. This might be slightly longer due to any conversations with the study team or when you sign the .
A specialist doctor called a looks at your scan. There will be a at the study van who will be able to give you your scan results that day if you have your scan there. You don’t get the results the same day if you have your scan in the hospital.
The radiologist also gives the results to the study team. Your study doctor then looks at your scan results with the results of your PSA density test when they receive this.
Results for everyone taking part
You get a letter sent to you with the combined results. And the same letter is sent to your GP. You should have your combined results within 3 weeks of your study visit.
The letter will let you know if you are ‘not at risk’ or ‘at risk’ of having prostate cancer.
Not at risk
You don’t need to do anything else.
At risk
This means that one of the tests showed that you need more tests to find out if you have prostate cancer.
Your GP will refer you to the urology team at the hospital. This team specialises in treating problems of the urinary tract, including the bladder, kidney and prostate.
This is for more tests which usually includes another MRI. This is usual NHS care and not part of the study. Your study team will refer you to the hospital if you do not have a GP.
Side effects
Blood tests are safe tests. There is a possibility of:
- bleeding and bruising - pressing hard when the needle is removed can help to stop it
- pain - this is normally mild and can last for a few minutes
An MRI scan is very safe and doesn’t use radiation. Some people can’t have an MRI but the checklist picks this up beforehand.
If you have any discomfort, or feelings of claustrophobia, during the scan, you can ask the team to stop it at any time.
We have more information about:
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Shonit Punwani
Supported by
Cancer Research UK
International Alliance for Cancer Early Detection (ACED)
University College London (UCL)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
