A trial looking at whole body MRI scans for prostate cancer that has spread to the bones (WISER-P)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Other

This trial is looking at whole body MRI scans for prostate to find out how well treatment is working.

It is open to men with prostate cancer that has spread to the bones and:

the cancer spread to the bones is getting worse
you are due to start a different or new treatment for this

More about this trial

Doctors can use a bone scan Open a glossary item , CT scan or both to find out how well the treatment is working for your prostate cancer that has spread to the bones.

A whole body MRI (WBMRI) scan is a special type of MRI scan Open a glossary item called a diffusion-weighted imaging (DWI) scan. This gives a more detailed image of the bones than a CT scan or a bone scan. Research has shown that WBMRI might be better than a CT scan or a bone scan at showing cancer in the bones and how well treatment is working. WBMRI, along with other clinical tests, might be able to help doctors decide sooner if treatment is working and change treatment sooner if it isn’t.

Because WBMRI gives a lot of detailed information it can take a while for the radiologist Open a glossary item to view and analyse the scan. As part of this study, the team are also looking at software that could do this quicker. Having the report from the software could also help doctors when they are looking at the scans in the clinic.

The aims of the trial are to find out:

how well WBMRI works for showing cancer in the bones
how useful the information from the software is for doctors when assessing the scans and making treatment decisions

Please note that taking part in the trial will not affect the treatment you have.

Who can enter

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this trial if all of the following apply. You:

have prostate cancer that has spread to the bones and it is getting worse
have had a CT scan, bone scan or an MRI scan of the area between the hips (pelvis) that shows your bone spread is getting worse within 8 weeks of joining the trial
are due to start treatment for cancer that has spread to your bones
are willing and able to attend all the scans in this trial. Your doctor can tell you more about this.
are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply. You:

are not able to, or willing to, have a whole body MRI scan. You might not be able to have a whole body MRI scan because you have metal pieces such as surgical clips in your body, you have a pacemaker or you are not comfortable being in a small, confined space.
have an area of cancer spread in soft tissue that is greater than 1cm in size. Your doctor will know about this.
have radiotherapy within 8 weeks before joining this trial
are planning to be in, or are in, a clinical trial where you would be taking an experimental drug or using a device

Trial design

Before taking part in the trial, your doctor will have done scans to assess your cancer as a part of your routine care. This will have included scans of your bones. From the results of the scans, they will have decided you need to start a different treatment.

The team need 126 people to take part. Everyone has a whole body MRI scan.

You have your scans, according to the group you are in on 2 different occasions:

before starting treatment
at 8 or 9 weeks after starting treatment

Whole body MRI scan
You lay down on the couch to have the whole body MRI scan Open a glossary item . Before having the scan, you have MRI coils placed around your head and body. These coils are light weight and stay in place for the duration of the scan. The head coil has a mirror in place so you can see towards your feet and outside the scan. When everything is ready the couch moves slowly back and forth through the scanner to take the pictures.

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You wear headphones during the scan because the scanner is noisy. You are able to talk to the radiographers during the scan if you feel uncomfortable. The radiographers will be able to talk to you. Towards the end of the scan, they will ask you to hold your breath for about 20 seconds. The number of times you need to hold your breath depends on what MRI scan the hospital uses.

You will be asked to lie still during the whole scan. This takes about 40 minutes.

Quality of life
You fill in questionnaires:

before you start treatment
at 8 to 9 weeks after starting treatment
1 year after you started treatment

The questions ask about:

your general health and wellbeing
what daily activities you can do
side effects
any help and support you have had from other health professionals such as your GP

These are quality of life questionnaires.

You don’t have to agree to do these questionnaires. You can still take part in the trial.

Hospital visits

You will need to make an extra visit to hospital to have your scans before you start treatment. Your scans at 8 or 9 weeks after starting treatment will be part of a routine visit. You will also need to attend your hospital 12 months after starting treatment for a follow up visit.

Side effects

The whole body MRI scan is a safe test but like all medical tests there are possible risks.

You are not exposed to any radiation with a whole body MRI scan.

You need to lie still for all of these scans. This can be uncomfortable and you may feel claustrophobic. The staff will do all they can to make you as comfortable as possible.

Your doctor will talk to you about the scans and what to expect before you agree to take part in the trial. They will also answer any questions you have.

We have more information about having an MRI scan.