A trial looking at using MRI to help diagnose prostate cancer (PRECISION)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 3

This trial used magnetic resonance imaging (MRI) before prostate biopsy to see if it is better at finding prostate cancer.

It was for people who have been asked by their doctors to have a sample of cells taken from the prostate (prostate biopsy).

More about this trial

Prostate biopsies are used to diagnose prostate cancer. Usually the doctor passes a needle up the back passage to the prostate, using an ultrasound scan to guide them. This is called transrectal ultrasound guided biopsy (TRUS).

The doctor takes a sample of cells from the prostate that might contain cancer. Sometimes the biopsies can miss the cancer cells or not show how serious they are.

This trial will look at whether an MRI scan called a multi parametric MRI (MP MRI) could show the prostate areas likely to have cancer. An MP MRI is a detailed MRI scan that uses an injection of dye (contrast medium Open a glossary item ) into a vein to make the images clearer and can help to find cancer.

Doctors will use the information from the MRI scan to take the biopsies. If there is an area seen on the MRI scan that the doctors think could be cancer, they will take samples from there. If there is no suspicious area on the MRI, then no biopsy will be taken at all. This happens in about 3 out of 10 people (30%). This means that some can avoid having a biopsy.

The main aim of this trial was to find out whether an MRI guided biopsy is as good as a TRUS biopsy at diagnosing prostate cancer.

Summary of results

The trial team found that an MRI guided biopsy was better than a TRUS biopsy for diagnosing prostate cancer.

This trial was open for people to join between February 2016 and October 2017. These results were published in 2018.

About this trial

This was a phase 3 trial. 500 people joined this trial.

It was a randomised trial. Everyone was put into 1 of 2 groups.

252 people had an MRI scan then targeted biopsy if needed
258 people had a TRUS guided biopsy

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In the MRI scan group if the results of the scan suggested prostate cancer was present then a targeted biopsy was taken.

In this trial researchers were looking at clinically significant prostate cancers. A clinically significant cancer had a Gleason score Open a glossary item

of greater than or equal to 3+4 (a Gleason sum of 7).

Results

The researchers found clinically significant cancer in:

95 (38%) of the people in the MRI scan targeted biopsy group
64 (26%) of the people in the TRUS guided biopsy group

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Quality of life

For quality of life at 1 day and 30 days after the biopsy there wasn’t much difference between the 2 groups.

Complications from the biopsy

A month after the biopsy people in the MRI group reported fewer complications.

The number of people who reported blood in the urine was:

30 out of every 100 people (30%) in the MRI group
60 out of every 100 people (60%) in the TRUS group

For blood in the semen it was:

32 out of every 100 people (32%) in the MRI group
60 out of every 100 people (60%) in the TRUS group

For pain at the site of the procedure it was:

13 out every 100 people (13%) in the MRI group
23 out of every 100 people (23%) in the TRUS group

For bleeding from the back passage (rectum) it was:

14 people out of every 100 people (14%) in the MRI group
22 people out of every 100 people (22%) in the TRUS group

For problems getting an erection (erectile dysfunction) it was:

11 out of every 100 people (11%) in the MRI group
16 out of every 100 people (16%) in the TRUS group

The team said these findings showed that for every 100 people having a biopsy there were fewer in the MRI group than the TRUS group.

2 out of every 100 people (2%) in both groups had a serious side effect.

Conclusion

The team concluded an MRI scan to assess the risk followed by an MRI targeted biopsy is superior to TRUS guided biopsy in diagnosing prostate cancer.

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:

10/02/2016

Recruitment end:

03/10/2017

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.

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

Chief Investigator

Professor Caroline Moore
Professor Mark Emberton

Supported by

NIHR Clinical Research Network: Cancer
University College London (UCL)
UCL Surgical and Interventional Trials Unit
NIHR Doctoral Research Fellowship
European Association of Urology Research Foundation (EAU RF)

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Email

Last review date

25 March 2019

CRUK internal database number:

13306