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 comparing whole body MRI scans to bone and CT scans to find out which is better at showing 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.

Half of the people taking part in this trial will have bone and CT scans. And half will have whole body MRI scans.

The aims of the trial are to find out:

whether WBMRI is better than bone and CT scans to see how well treatment is working
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. It is a randomised trial. A computer puts you into a group. Neither you nor your doctor can choose which group you are in. The groups are:

whole body MRI scan
bone scan and CT scan

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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.

Bone scan
Before the bone scan you need to drink plenty of fluids and arrive about 2 to 3 hours before the scan is due. In the hospital you have a thin plastic tube (cannula) put into a vein. Through this tube you have a radioactive injection Open a glossary item called a tracer. The tracer goes round your body and collects in the bones. This takes about 2 or 3 hours.

During the scan you lie on a couch that moves slowly back and forth through the scanner. You will be asked to lie still during the scan. This takes about 30 minutes to an hour.

You need to drink plenty of fluid after the bone scan. This helps get rid of the radioactive tracer. Your body gets rid of the tracer within 24 hours. It comes out in the urine.

CT scan
When you have the CT scan you might have an injection of a contrast medium Open a glossary item . You have this through a thin plastic tube (cannula) before you have the scan. The radiographer will tell you if you need to have it.

For the scan you lie on a couch. This moves slowly back and forth through the scanner. You will be asked to lie still during the scan. The scan takes between 20 and 30 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.

Bone and CT scan group
You may have already had a bone scan and CT scan as part of your routine care before you join this trial. If you have had these within 6 weeks of starting treatment, you don’t have to have these scans again. You have scans about 8 to 9 weeks after starting treatment.

Side effects

Whole body MRI scans, CT scans and bone scans are safe tests but like all medical tests there are possible risks.

Exposure to radiation during CT scans and bone scans can slightly increase your risk of developing cancer in the future. Talk to your doctor if this worries you.

As part of the CT scan, you might have a contrast medium. Rarely, people have an allergic reaction to it. This most often starts with weakness, sweating and difficulty breathing. The radiographer Open a glossary item will ask if you have any allergies before you have the contrast medium. Tell them immediately if you feel unwell after having it. They can give you treatment to relieve your symptoms.

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.

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