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A study looking at high definition MRI scan and ultrasound guided biopsy for diagnosing prostate cancer (MULTIPROS)
This study is for men who are due to have tests to see if they have prostate cancer.
More about this trial
Your doctor will send you for tests if they think you have prostate cancer. You usually have a sample of cells removed from your prostate to check for cancer. To do this, the doctor passes a fine needle along an ultrasound probe and into the prostate gland. This is a transrectal ultrasound (TRUS) guided biopsy.
Sometimes, the biopsies can miss cancers or not show how serious they are. And they can show up slow growing cancers that don’t need treating because they will never become life threatening.
This study will look at a type of MRI scan called multi parametric (MP) MRI, which is a high definition MRI scan. The researchers want to do an MP MRI scan before a biopsy. They want to see if it will:
- help to diagnose prostate cancer
- tell the difference between serious and less serious cancers
Who can enter
The following bullet points list 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.
You may be able to join this study if you are going for tests at either Ninewells Hospital Dundee or the Aberdeen Royal Infirmary in Aberdeen and all of the following apply.
- Your PSA test result is less than 20ng/ml and your doctor has done a digital rectal examination (inserted a gloved finger into your back passage) and your prostate gland did not feel normal
- You are aged between 40 to 75
You cannot join this study if any of these apply. You
- Have had prostate cancer in the past
- Have had an infection in your prostate gland called acute prostatitis
- Have had a prostate biopsy
- Are unable to have a prostate biopsy for any reason
- Have had your prostate gland removed by a type of surgery called transurethral prostatectomy
- Cannot have an MRI scan for any reason – this could be because you have metal clips or a pacemaker in your body, or you cannot cope with small spaces, or your kidneys do not work well enough to flush through the MRI
contrast, or you are allergic to the MRI contrast
- Have any other condition that the study team think could stop you taking part
The researchers would like up to 600 men to take part in this study.
You have an MP MRI scan as an outpatient at either Ninewells Hospital Dundee or Aberdeen Royal Infirmary.
The next part of the study is randomised. You are put into 1 of 2 groups.
- One group has a routine TRUS biopsy
- The other group has a TRUS biopsy and additional samples taken using the MP MRI images
If you have prostate cancer you might have your prostate gland removed (a prostatectomy). If this happens the researchers will compare the results of the examination of your prostate gland with those of the MRI scan images and your biopsies.
You have your MP MRI scan and biopsy at the hospital. You should have these as an outpatient and shouldn’t need to stay overnight.
The MP MRI scan takes approximately 1 hour. Before the scan you have a small tube (a cannula) put into your arm. This is so you can have 2 drugs. One drug will relax the muscles of your bowel. This helps make the scan images clearer by stopping your bowel from moving.
The other drug is a contrast medium called Gadolinium. This helps to show up any areas in your prostate gland that could be cancer.
Very rarely the contrast injection for the MP MRI scan may cause an allergic reaction. These reactions are usually mild. Staff at the MRI unit will be able to treat your reaction if this happens to you.
Other side effects include
- mild headache
- feeling sick
- burning sensation when you have the drug
- slight skin rash
If you are in the group having the TRUS biopsy and additional samples the procedure will take slightly longer. But you should not have any additional side effects. We have information about having a TRUS biopsy (needle biopsy).
How to join a clinical trial
Professor Ghulam Nabi
Chief Scientist Office
NIHR Clinical Research Network: Cancer
Prostate Cancer UK
University of Dundee - Tayside Clinical Trials Unit