"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A study looking at using a detailed type of MRI scan to help diagnose prostate cancer (PROMIS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This is a study to see how useful a type of MRI scan called multi parametric (MP) MRI is as a test to diagnose prostate cancer.
If you have a raised PSA blood test result, you will usually have a sample of cells removed from your
This study will look at a type of MRI scan called multi parametric (MP) MRI, which is a high definition MRI scan. It will look at whether MP MRI can show doctors which men could safely avoid having a TRUS biopsy. And, if it can help doctors to carry out more accurate biopsies if men do have them. The aims of the study are to
- See how good MP MRI is at showing which men don’t need to have a biopsy
- See whether MP MRI helps to find cancers that do need to be treated
- Work out how cost effective it would be to use MP MRI as a test for prostate cancer
Who can enter
You may be able to enter this study if
- You have been told by your doctor that you might have or are at risk of developing prostate cancer, or you are going to have a prostate biopsy
- Your doctor thinks that if you do have cancer, it is still completely contained inside your prostate
- You have had a PSA test result of less than 15ng/ml in the last 3 months
- You are fit enough to have a
general anaesthetic, or an anaesthetic injected into your spine
- You are fit enough to have all the procedures in this study – you can ask your doctor about this
- You are at least 18 years old
You cannot enter this study if you
- Have taken drugs called finasteride or dutasteride (or a similar drug) in the last 6 months – you can check this with your doctor
- Have already had a prostate biopsy, prostate surgery or treatment for prostate cancer - if you have had treatment for an enlarged prostate that is not caused by cancer, or for difficulty passing urine, you may still be able to take part
- Have had a urine infection or your prostate has been badly
inflamedin the last 3 months
- Cannot have an MRI scan for any reason – this could be because you have metal or a
pacemakerin your body, or you cannot cope with small spaces, or your kidneys do not work well enough to flush through the MRI contrast
- Have any other condition that would stop you taking part – the study team can advise you about this
This study will recruit about 720 men.
When you join the study, you will have an MP MRI scan of your prostate. A few weeks later, you will have 2 types of biopsy - one after the other. The study team call this a combined biopsy procedure (CBP). The 1st biopsy is called template prostate mapping (TPM), and the 2nd is the standard TRUS guided biopsy.
Seven days before your biopsies you will start a course of tablets to relax your prostate which may help prevent problems passing urine after the biopsies. You continue to take these tablets for 2 weeks after the biopsies. You will also have a course of antibiotics to help prevent infection. You should not eat anything for 6 hours before your biopsies and you can only drink water up to 4 hours before the biopsies.
You have the combined biopsy under either general anaesthetic or an anaesthetic injected into your spine. The team will then gently put a probe into your rectum and a catheter, to collect urine, into your bladder. A TPM biopsy uses a grid called a template. This template has holes every 5mm, to guide the doctor where to put the biopsy needle. They will place this against the skin between your
The team will compare the results of all 3 procedures so that they can see which are the most accurate to use when diagnosing prostate cancer, and which are the most helpful for planning treatment. They will let you know the results when you see them for your follow up visit. They will ask if you would mind filling out a questionnaire about your health and quality of life.
They will also ask if you would be willing to give some extra blood and urine samples for research. If you agree to this, you will give a urine sample, and then drink some water. A researcher will put a gloved finger into your back passage to examine you. They will gently stroke your prostate gland and then ask you to give another urine sample.
Lastly, they would like to look at the types of areas that the men taking part live in. They will ask if you would be happy for them to record and use your postcode for this. You do not have to agree to this or to giving the extra samples if you don’t want to. You can still take part in the rest of the study.
Before you join the study you will see the doctor and have some tests. These tests include
- Blood and urine tests
- Examining your prostate though your back passage
Your MP MRI scan will last between 30 and 40 minutes. You have your combined prostate biopsy as soon as possible after the MRI. Before your biopsies, you may need to come to hospital again so that a nurse can check you are fit enough to have the anaesthetic.
On the day of your combined biopsy you come to hospital a few hours before the procedure. The biopsy itself takes about 40 minutes. You will stay at the hospital afterwards until you feel steady on your feet and have passed urine. Most men are ready to go home about 2 to 4 hours later.
You visit the hospital to collect your results 2 to 4 weeks after your study biopsy.
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.
Both biopsy procedures have some risks and possible complications. These are similar but there are 2 main differences. TPM has a lower infection rate than TRUS guided biopsy because the needle is going through the skin rather than the back passage. TPM takes more samples than a TRUS guided biopsy, so there is more bruising. And the prostate can swell making it difficult to pass urine.
Having these 2 types of biopsy together is a new thing. So there could be side effects from this that doctors don’t know about yet. Possible side effects of the combined procedure include
- Temporary discomfort in the back passage
- Burning feeling when you pass urine
- Blood in your urine for 2 to 3 days
- Problems with erections for about 6 to 8 weeks
- Skin or urine infections
- Difficulty passing urine
- Bruising of the skin or scrotum
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.
Professor Mark Emberton
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
University College London (UCL)