Today, we’re excited to announce plans for more than £2m of funding to develop a new risk assessment tool for GPs that should indicate the presence of cancer far more accurately than the current PSA test. The landmark research project – involving scientists from around the world – will not only help men understand their risk of aggressive prostate cancer, but also what to do about it. Our Director of Research, Dr Iain Frame, gives us the full lowdown on this "massive" development for diagnosing the most common cancer in men in the UK.
So what is it?
It’s a straightforward, easy-to-use tool that’s built in to GPs’ existing computer systems. It will let them input information like a man’s age, ethnicity, family history and PSA level, and get back an indication of his own individual risk of having aggressive prostate cancer.
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But more than that, it will then give both the man and his doctor a clear idea of what they should do next, using a traffic-light system: red to go straight to a urologist, green to go home and not worry about another test for years, or amber for something in between.
The results can then be printed out for the man to keep or used as an opportunity to suggest appropriate information resources for him. But the first step is getting the calculation right.
Will PSA level, ethnicity, age and family history be the key considerations?
Not necessarily. Exactly what factors need to feed into the calculation will be worked out in the first year of the project, but we’re pretty certain these four will be included. The researchers will start with a long list of possible risk factors. For each one, they’ll weigh up the pros and cons. For example, does it make the calculation more accurate? How much does it cost to add in? How difficult is it to measure? Will it be unpopular with men or doctors and make them less likely to use the tool?
Overall, they need to come up with the right balance of risk factors that give the most accurate picture of a man’s risk, but is still easy and quick to use within a normal GP appointment and is cost-effective for the NHS.
What about the new genetic tests or protein biomarkers we hear about all the time that can help diagnose aggressive prostate cancers?
The absolute beauty of this project is that nothing is ruled out. We can start right now with those risk factors and biomarkers that are already well established. But as more and more new genetic or protein risk markers are validated, they can be added into the calculation. The researchers are setting out from the start knowing that this tool needs to be flexible and futureproof.
Hasn’t the new Stockholm-3 test already done the job for us?
Not quite. In that study, researchers trialled a new screening programme that used the PSA test in conjunction with a panel of new tests for genetic and protein biomarkers. The results were really impressive and did exactly what we hope this risk tool will also do, reducing the number of men referred for biopsy without reducing the number of aggressive cancers they detected. This is exactly what we’re aiming for so we’re really excited by this research. The trouble is that it’s not quite ready to be added into the risk tool yet.
This study was only run in Stockholm, which doesn’t have the same levels of ethnic or socio-economic diversity as the UK population. So we need to test whether this new test panel will work as well in the UK as it did in Sweden. We also need to work out whether it will work both practically and financially within the NHS. This means running another clinical trial to validate the results in the UK.
We’re working with the researchers to put together a proposal for this now and hope to announce funding for this project later this year. If the results hold up, they will absolutely be built into the risk tool. That’s the benefit of working on both these projects together: both research teams know that the ultimate aim is to join forces to make this tool the best it can possibly be.
So how long before we’ll see it in general use?
The first year of the research project will be dedicated to building and refining the actual mathematical calculation. The researchers have a bit of a head start, because they’ve all worked on similar models before and already have the European and UK data they need to work with. In this time, they’ll also find a way to make the calculation work with the computer systems that GPs already use.
After that, there’ll be a two-year user-testing period, when the tool will be trialled with GPs and men to make sure that it’s accurate and both popular and easy enough that GPs will be happy to adopt it once it’s ready to roll out.
That takes us to around three years’ time. To be honest, we can’t be sure whether the results of the first round of testing will be so good that we’ll be able to push for an immediate roll out of the tool across the country, or whether we’ll have to do some bigger trials first. Either way, we hope that a large number of men will have access to the tool at this stage and it will be in the hands of all GPs within five years.
How much will it cost?
The first three years of the project will cost around £1.5m, and it will take around an extra £750,000 to validate the Stockholm-3 results properly. So you can see why we really need to keep the energy up with our fundraising now. We know what we need to do but it won’t be job done until the money’s in the bank. You can donate now to help us make this a reality.
Will this be the first UK screening programme for prostate cancer?
It’s too early to be talking screening programmes yet. First we need to make sure it works as well as we hope it will. If it does, then we’ll certainly be working with the UK National Screening Committee to see what needs to happen to start a programme using our risk tool.
Who are the scientists involved?
We’ve got a group of scientists from around the world – including the UK, Netherlands, Canada and the USA – working together on this project, as well as GPs and primary care experts who can advise the team on how to make this work best in UK primary care.
Just how big a deal is this new tool?
It’s massive. Improving diagnosis is one of the four key aims of our new research strategy, and this risk tool is going to be a huge step towards that. But improvement is a constant process, which is why the fact that we can keep building on and improving this risk tool at every step is so important. I think it’s highly likely that within a few years, when this tool is in use in GP surgeries across the UK, fewer men will be referred to urologists with harmful or no prostate cancer at all, while we’ll also be increasing the number of aggressive prostate cancers we’re catching early enough to treat. It’s a win-win plan.
Will it only benefit men in the UK?
Our initial funding and the first validation for this study will all be done with UK and EU data, and the testing will be carried out within the UK health system. Improving diagnosis for men in the UK is our primary aim. But prostate cancer diagnosis is a problem the world over, and one of the reasons the international researchers were so excited about working on this project was the opportunity to lead on something that – with a bit of further refinement – could make a difference on a global scale.