Comparison of diagnostic accuracy of Luminal Index and Multi-parametric MRI for Accelerated deTEction of significant prostate cancer (CLIMATE)
What is the purpose of this study?
We are trying to find a new way to detect prostate cancer in patients suspected to have clinically significant disease. We think a new magnetic resonance imaging (MRI) scan called Luminal Index MRI, which only takes 5-10 minutes, might be as good as, or better than the standard MRI that is currently used for assessing the prostate. To know if this is the case, we need to compare our new scan to the standard MRI scan.
Why is this research being done?
The standard MRI scan for assessing the prostate, known as multi-parametric MRI, takes between 30-45 minutes and in most cases will need an injection of dye to be given into a vein in your arm. Although this is the best type of scan currently available to look for prostate cancer, we know that it is not perfect. Around half of the people that go on to have biopsy after they have something found on the standard scan actually have either no cancer found at biopsy or have a ‘low grade’ cancer that is not of concern and does not require treatment.
There are another couple of things that make the standard scan not perfect. First, if you have air within your bowel next to your prostate at the time of the scan, this can distort the images and make it more difficult for doctors to find a cancer. Second, in most cases the standard scan will need an injection of a special dye into a vein in your arm. We know this dye helps to see things in the prostate that might be cancer, but we also know that some parts of the dye that is injected can be left in your body for a long period of time. This does not have any immediate bad effect on health, but we are not sure about the long-term effects of this.
What are the benefits of taking part in the study?
The new scan we are trying out in this study, called Luminal Index MRI, allows us to look at the prostate in detail using a single 5-10 minute scan, and it does not need any injection for better scan pictures and may be better able to assess the prostate than the standard MRI scan.
If this study does in fact confirm that the new scanning method is better than, or even as good as, the standard MRI , our new scanning technique could make it cheaper, faster, easier and better to get a diagnosis of prostate cancer made all over the world.
Who is being included in the study?
We are planning to enrol 702 people from hospitals across the UK over a 3-year period. It is likely that most people that enter the study will have had a PSA (Prostate Specific Antigen) blood test and that blood test result may have been higher than normal. Routinely the next step would be to have a standard MRI scan of the prostate to investigate further. In this study we will compare our new scan method to the standard MRI scan.
What is the status of the study?
The CLIMATE study is currently recruiting patients.
Who is carrying out the study?
The study is being conducted by is University College London, who is the sponsor of the research. The study is funded by The Urology Foundation.
If I have any questions, who can I contact?
If you have any questions please speak to your hospital medical team. You can also contact us by email at ncita.climate@ucl.ac.uk
For more information see the CLIMATE study record on ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT05020522