A study comparing 2 different MRI scans to diagnose prostate cancer (CLIMATE)
Cancer type:
Status:
Phase:
This study compares the standard of care MRI (SOC MRI) scan with the luminal index MRI scan to diagnose prostate cancer.
It is open to men who are having an 
because their doctor thinks they might have prostate cancer.
More about this trial
To test for prostate cancer you might first have an MRI scan. The results of the scan can be either positive or negative.
A positive results shows that there might be cancer in the prostate. To confirm this you have a sample of tissue ( taken from the prostate gland. A negative result means there is no sign of cancer in the prostate.
The SOC MRI scan doctors use is either a multiparametric MRI scan (mpMRI) or a biparametric MRI scan (bpMRI) to scan the prostate.
There is another scan they can use. It is the luminal index MRI scan (LI-MRI). It is not known whether the LI-MRI scan is as good as the SOC MRI scan at detecting the possibility of prostate cancer.
In this study the researchers want to compare the 2 scans.
The aim of this study is to find out whether the LI-MRI scan is as good as the SOC MRI scan at detecting possible prostate cancer.
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 study if:
- your doctor has referred you to have an MRI scan because you might have prostate cancer
- you are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- had a
PSA of more than 20 ng/ml within the past 6 months - have previously had prostate cancer
- are having hormone treatment within the 3 months before the MRI scan apart from
anti androgen tablets such as bicalutamide and flutamide. Or if you are taking finasteride or dutasteride for benign prostatic hyperplasia (BPH) or male pattern hair loss. - are not able to have an MRI scan. This could be because you have metal pieces in your body or you are not able to be in confined spaces.
Trial design
The team plan to have 702 people take part.
Everyone will have a standard of care MRI scan (SOC MRI) and the luminal index MRI scan (LI-MRI). You have both scans on the same day. The SOC MRI scan takes 30 to 45 minutes. The LI-MRI scan takes no more than 10 minutes.
Specialist doctors (research ) review the LI-MRI scan. The hospital’s radiologist reviews the SOC MRI scan. The research team combines both the results into 1 report. And this is sent to your doctor at the hospital.
The combined report may come back as negative. This means that neither scan results have shown signs of possible prostate cancer. And no further action is needed.
The combined report may come back as positive. This means that one or both scan results showed signs of possible cancer. Your doctor won’t know whether it is one scan or both scans that are positive.
Your doctor will do a prostate biopsy to confirm whether there is cancer or not. A prostate biopsy is taking small pieces of the prostate tissue to look at under a microscope in the laboratory.
There are 2 different ways of getting a biopsy:
Your doctor will explain more about the different biopsies and which might be best for you to have.
Sub study
The team will ask for a blood sample before you have the scans. They will use this sample to see if they can find substances in the blood (). These biomarkers might be able to help doctors to make a diagnosis in the future.
You don’t have to agree to take part in the sub study.
Samples for research
The team will ask for any extra tissue not required for your diagnosis to be stored in a secure place for future research. The sample will not have your name on it.
You don’t have to agree to have a sample of the biopsy stored for future research.
Hospital visits
You see the doctor before taking part. This is to:
- explain the study to you
- see if you are able to join
- answer any questions you may have
You might have the scans on the same day as this appointment. If not you’ll need to go back to the hospital to have the scans. You have both the SOC MRI scan and the LI-MRI scan on the same day.
You see the doctor for the results of the scan.
If both scans show that there is no sign of cancer you don’t have any further hospital visits.
If one or both scans show that there might be cancer your doctor will arrange for you to have a prostate biopsy at the hospital. You will then see the doctor for the results of the biopsy. They will then tell you more about what happens after.
Side effects
MRI scans are a safe procedure that are in routine use.
If your MRI scans show there might be cancer, you will have a biopsy taken. Side effects of a biopsy might include:
- bleeding
- infection
- difficulty passing urine
- pain
Your doctor will talk to you about having a biopsy and the side effects.
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)
John Black Charitable Foundation
The Urology Foundation
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
