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Miss Hannah Johnson
+44 203 4376712
WISER-icrctsu@icr.ac.uk


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Be Part of Research - Trial Details - Using software to measure bone disease on imaging for patients with prostate cancer

Using software to measure bone disease on imaging for patients with prostate cancer

Recruiting

Open to: Male

Age: Adult

Medical Conditions

Prostate cancer


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


In advanced prostate cancer, the spread of cancer to bones is common. Currently the most widely used scans to find out if cancer has spread to the bones are bone scans and computed tomography (CT). These scans are also used to find out how well treatment for advanced prostate cancer is working.
Recent research has shown that a different type of scan, called whole-body magnetic resonance imaging (MRI) may be better at showing cancer in the bones and how well a treatment is working. Whole-body MRI involves a special type of MRI scan, called diffusion-weighted imaging, which provides a measurement of how much bone disease there is in the whole skeleton and more information about what is going on in the cancer cells. This more detailed information cannot be obtained using a CT scan or bone scan. It has been shown that it may be possible to assess whether treatment is working more quickly using whole-body MRI compared to bone scans and CT scans. The information from the whole-body MRI, along with other clinical assessments, may help doctors decide whether the treatment is working sooner and change it if it is not working. This will help avoid patients remaining on a treatment that is not right for them.
As the whole-body MRI scan provides detailed information about the cancer in the bones it can take a long time for the radiologist to review and analyse the scan. As part of this study we are also assessing an approved imaging software for whole-body MRI. This software is used to automatically identify and measures bone disease on the whole-body MRI and produce a summary report of the scan results. This software will reduce the amount of time it takes to analyse the whole-body MRI scan. The summary report may also help the oncology doctors when they review the scan results in clinic.
The aim of this study is to find out whether whole-body MRI is better at finding out how well a treatment is working compared with bone and CT scans. This study will also evaluate the whole-body MRI software to find out how useful this is for the doctors when they assess the scans and make decisions about treatment.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Sep 2023 01 Mar 2025

Prior to being invited to take part in this study, and as part of routine care, participants will already have had scans to assess their cancer, including that in their bones. A decision will have been made that they will soon start a different treatment. Planned treatment will not change if someone takes part in this study.
After a participant has given consent they will have either bone and CT scans or a whole-body MRI scan before they start treatment. These scans will then be repeated approximately 8-9 weeks after the start of treatment. Apart from these scans, all other clinical assessments such as bloods tests, will be performed as part of routine care and will not change due to participation in this study. The participant will be seen regularly by their doctor. We will collect information from the hospital about how the participant is doing at their routine follow-up visits up to 12 months after the start of planned treatment.
Half of the participants in the study will receive bone and CT scans and the other half of patients will receive whole-body MRI scans. In some cases, and as part of routine care, an MRI scan of the pelvis may be performed instead of or as well as the CT scan, and this would be allowed if taking part in the study.
The choice of which type of scan the participant has is made randomly (by a computer) at the time they enter the study and is the equivalent of tossing a coin. This process is called randomisation. This is the best way to make sure that the patients in each group are as similar as possible. Then, if the scans in one group are shown to be better than those in the other group, it is more likely to be because of the scans themselves, rather than because the patients in one group are somehow different from those in the other groups.
In addition to the scans described above participants will also be asked to take part in an optional patient reported outcome sub-study. If they decide to take part, they will be provided with a patient reported outcomes booklet. This booklet includes questions about their general health and how their diagnosis and treatment effects their daily life.
They will be asked to complete this booklet before they start treatment, and again at 8-9 weeks and 12 months after the start of treatment. The questionnaire is optional and participants can still take part in the main study if they do not consent to this sub-study.
The booklet is split into two sections:
Quality of life: A short questionnaire asking about their quality of life and general health.
Health Resource Use: A questionnaire about how treatment for cancer affects their daily life. This includes questions about any help or support they are receiving, healthcare visits such as appointments with the GP and any expenses associated with their health and treatment. Participants will only need to answer these questions at the time they have their scan(s) at 8-9 weeks after starting treatment and again at 12 months after starting treatment.
A member of the local medical team will explain these questionnaires to the participant and answer any questions that they may have. The questionnaire should take about 10 minutes to complete.


This study is for people over the age of 18 who have been diagnosed with advanced prostate cancer that has spread to the bones and who will shortly be starting a different treatment.

You can take part if:



You may not be able to take part if:


1. Unsuitable for WBMRI (patient refusal and/or contraindicated)2. Patients with RECIST-measurable disease3. Any radiotherapy within 8 weeks prior to trial entry (chemotherapy or other anti-cancer therapy are permissible).


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden Hospital (surrey)
    Downs Road
    Sutton
    SM2 5PT

Benefits-
All patients in the study will have scans to find out how well treatment is working and these types of scans are already widely used to diagnose and monitor patients with cancer. The information we get from this study will help us find out if whole-body MRI is better at showing how well a treatment is working compared with bone and CT scans in patients with advanced prostate cancer involving the bones. Although participants may not directly benefit by taking part in the study, it will help to answer important questions and we hope will improve treatment for men with advanced prostate cancer in the future.
Disadvantages and Risks-
Because of their participation in the study, patients will need to visit the hospital to have a scan (or scans) prior to starting treatment. The number of hospital visits after this will be the same whether or not they participate in the study.
If a participant takes part in this study, they could have CT scans and bone scans. Some of these could be extra to those that they would have if they did not take part. These procedures use ionising radiation to form images of the body and provide the doctor with other clinical information. Ionising radiation may cause cancer many years or decades after the exposure. The chance of this happening to participants is extremely small.
Whole-body MRI is a safe and painless procedure and is not associated with any radiation exposure. There is no evidence that the magnetic fields and radio waves used during MRI scans cause any harm to the body. Although there is no radiation exposure with MRI scans, the procedure involves the participant keeping still whilst on the scanner table for the duration of the scan. They will be made as comfortable as possible before starting but it can be noisy and they will be in a narrower tunnel than for a CT. During the whole-body MRI scan the participant may feel the scanner table vibrate. This is normal and expected. Some patients may feel claustrophobic and may experience discomfort related to lying still in an enclosed space for a prolonged period of time while the scan is being taken. The radiographer performing the scans will ensure they are as comfortable as possible before starting the scan.


The study is sponsored by Institute of Cancer Research and funded by National Institute for Health and Care Research.




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Read full details for Trial ID: ISRCTN54072577

Or CPMS 55351

Last updated 12 October 2023

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