A study looking at using a detailed type of MRI scan to help diagnose prostate cancer (PROMIS)

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Cancer type:

Prostate cancer

Status:

Results

Phase:

Other

This study was to see how useful a type of MRI scan called multi parametric (MP) MRI was to diagnose prostate cancer.

More about this trial

If you have a raised PSA blood test result, you usually have a sample of cells removed from your prostate to check for cancer. The doctor passes a needle up your back passage to your prostate, using an ultrasound scan to guide them. This is a transrectal ultrasound (TRUS) guided biopsy
 
Most people 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 don’t need to be treated because they will never become life threatening.
 
This study looked at a high definition MRI scan called multi parametric (MP) MRI. It looked at whether the MP MRI showed which people could safely avoid having a TRUS biopsy. And if it helped doctors to carry out more accurate biopsies for people who did have a TRUS biopsy. 
 
In this study everyone had a MP MRI scan and a combined biopsy procedure. A combined biopsy procedure is a TMP (template mapping) biopsy followed by a TRUS guided biopsy. 
 
The aims of the study were to:
  • see how well MP MRI showed which people didn’t need a biopsy
  • see whether MP MRI helped to find cancers that didn’t need treatment
  • work out how cost effective MP MRI was as a test for prostate cancer

Summary of results

The study team found that using MP MRI could reduce the number of people who would need a TRUS biopsy to diagnose if they had prostate cancer. 
 
This study was open for people to join between March 2013 and June 2016. These results were published in January 2017. 
 
About this study
Everyone who joined the study had a MP MRI scan followed by the combined biopsy procedure (TMP biopsy and a TRUS guided biopsy).
 
The researchers used the TMP biopsy because it took samples from the entire prostate gland. This made it the most accurate test and they used it find out how many people had prostate cancer. 
 
In this study researchers were looking at clinically significant prostate cancers. A clinically significant cancer means a Gleason score Open a glossary item of greater than or equal to 4+3 or was at least 6mm in length.
 
723 people agreed to join the study. Of these 576 had the MP MRI scan and the combined biopsy procedure.
 
The TMP biopsy showed that of these 576 people, 408 (71%) had cancer. Of these 408 people, 230 (41%) had a clinically significant cancer.
 
Results
The researchers wanted to know how many times the MP MRI scan and the TRUS guided biopsy was able to correctly identify clinically significant cancers. They found it was: 
  • 93 out of every 100 times (93%) for the MP MRI scan
  • 48 out of every 100 times (48%) for the TRUS guided biopsy

They also looked at how many times the 2 tests were able to correctly identify there was no cancer. They found it was:
 
  • 89 out of every 100 times (89%) for the MP MRI scan
  • 74 out of every 100 times (74%) for the TRUS guided biopsy

The team then considered proposed situations where the MP MRI scan was used first to find out if a TRUS guided biopsy might be needed. They said that doing the MP MRI scan first could mean that for 27 out of every 100 times (27%) the TRUS guided biopsy mightn’t be necessary. 
 
They said that if MP MRI scan was used first to find out if a TRUS guided biopsy was needed more clinically significant cancers could be found. And this could be as high as 18 more out of every 100 times (18%). 
 
Cost effectiveness
The team are still analysing the cost effectiveness of the PROMIS study. 
 
Conclusion
The team concluded that the number of clinically significant prostate cancers found could be increased if a MP MRI scan was done first. And unnecessary biopsies would be reduced. 
 
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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)

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Last review date

CRUK internal database number:

7794

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.”

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