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.

Cancer type:

Prostate cancer





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 prostate Open a glossary item to check for cancer. The doctor passes a needle up your back passage to your prostate, using an ultrasound scan Open a glossary item to guide them. Doctors call this procedure transrectal ultrasound (TRUS) guided biopsy. Most men having a TRUS biopsy will not have prostate cancer.  Sometimes, these biopsies can miss cancers or not show how serious they are. And they can show up very slow growing cancers that actually don’t need to be treated 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. 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 Open a glossary item, 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 inflamed Open a glossary item in the last 3 months
  • Cannot have an MRI scan for any reason – this could be because you have metal or a pacemaker Open a glossary item in your body, or you cannot cope with small spaces, or your kidneys do not work well enough to flush through the MRI contrast Open a glossary item
  • Have any other condition that would stop you taking part – the study team can advise you about this

Trial design

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 scrotum Open a glossary item and back passage, and collect samples from your whole prostate. You have some local anaesthetic Open a glossary item to this area after the TPM is complete. You then have the TRUS guided biopsy during the same anaesthetic.

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.

Hospital visits

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.

Side effects

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

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Mark Emberton

Supported by

Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
University College London (UCL)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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