Groundbreaking Screening Trial Poised to Save Thousands of Men’s Lives from Prostate Cancer
The TRANSFORM trial has also been backed by the National Institute for Health and Care Research (NIHR) and Movember, who have committed £17.5million towards the trial between them.
Among the six research leads are Professors Mark Emberton and Caroline Moore from the UCL Division of Surgery & Interventional Science, who will work with co-leads from Imperial College London and Queen Mary University of London, as well as 16 co-applicants from across the UK.
TRANSFORM will begin recruitment of hundreds of thousands of men from across the UK in 2025. It is hoped the first results will be available in as little as three years’ time.
Previous trials using prostate-specific antigen (PSA) tests and biopsy to screen for prostate cancer have shown that it is possible to prevent between 8% and 20% of prostate cancer deaths, depending on how regularly men are screened.
Professor Emberton, Dean of UCL Faculty of Medical Sciences, said: “We learned from our previous attempts at prostate cancer early detection that the tools we had available to us were very blunt. Though they were the only tools we had at the time and better than nothing.
“Today we have a different set of tools, including the ability to ‘see’ the cancer by virtue of MRI scans. This puts us in a position to determine what combination of tests work best to identify which men are at risk of cancers, which if left alone, would impact on their quantity and quality of life.”
TRANSFORM will test new approaches that have the potential to more than double this impact and reduce prostate cancer deaths by up to 40%. With over 12,000 prostate cancer deaths in the UK alone annually, this could mean thousands of men saved each year and many thousands more worldwide.
Dr Matthew Hobbs, Director of Research at Prostate Cancer UK, said: “Prostate cancer is the most common cancer without a screening programme and it’s about time we changed that.
“We know that earlier diagnosis saves lives, but previous trials haven’t been able to prove that enough men would be saved using PSA tests alone, while they did show that these old screening methods caused significant unnecessary harm to men. We must now prove that there are better ways to find aggressive prostate cancer that will save even more lives while causing less harm.
“That’s why I’m so delighted and proud to announce TRANSFORM. This is the research that will get us there. It’s the biggest research investment we’ve ever made – but by putting this money in now, we expect to double the number of men that could be saved by screening, while at the same time reducing any harm caused.
“This could save thousands of men’s lives every year in the UK alone. But it won’t just be the UK – this trial could change practice globally – so we’re into tens of thousands of men saved each year. This is a pivotal moment in the history of prostate cancer research and we’re proud to be leading the way, and to be supporting some of the best researchers in the world to make it happen.”
Prostate Cancer UK worked in consultation with the National Screening Committee and NIHR to make sure the trial will provide the evidence needed to revolutionise prostate cancer diagnosis. It will compare multiple methods of screening, and compare these against how men are tested now, to find the safest, most accurate and cost-effective way to screen men for prostate cancer.
The massive scale of the trial will also enable the team to create a biobank of samples, images and data at a scale never seen before in prostate cancer. This will be available to all cancer researchers and is predicted to spur a wave of new discoveries and provide a platform to prove the accuracy of the next generation of diagnostics.
Crucially, the trial has been designed flexibly and will be able to incorporate promising new testing methods at any stage of the process.
In the first stage of the trial, which will include 12,500 men, the researchers will compare four potential screening options, including PSA blood tests, faster versions of MRI scans and genetic testing to identify those at higher risk.
These new approaches will be compared to the current NHS diagnostic process to show which methods perform best and should therefore be taken forward into the second, larger stage of the trial.
The first stage will take three years to complete and will produce important results about the benefits and harms of the current diagnostic tests used in the NHS today. Those early results could start to impact the way men are tested for prostate cancer at that point.
In the second stage of the trial, the researchers will test the most promising option or options in a much bigger group of up to 300,000 men to provide the definitive evidence for the best way to screen men for prostate cancer.
The team will follow participants over at least 10 years to track how these screening approaches impact the number of lives saved, overall quality of life, as well as how many men might experience harms associated with potentially unnecessary biopsies and treatment.
Professor Moore said: “TRANSFORM is designed to reach those at highest risk, including those in communities that have been under-represented in previous studies. This will include black men, and those living in areas with higher rates of late diagnosis of prostate cancer. UCL is delighted to be part of the team who will deliver this study.”
Samuel Nelson, 64, from Essex, was diagnosed with prostate cancer in 2017. As a Black man he was at higher risk of the disease and has a strong history of prostate cancer in his family. He also has three sons, who will be at greater risk in the future.
He said: “I have three sons who will be at higher risk. It would be wonderful to know there was a process to check them regularly.
“For me, getting a screening programme is so important. Black men are twice as likely to get prostate cancer. My dad died of prostate cancer, my uncle had it too and because it’s in the family, me, my four brothers and my three sons all have an even higher risk.
“When I learned this, I started being regularly tested and that’s how I was diagnosed. But I wouldn’t have known – I had no symptoms. And so many men don’t know about prostate cancer, so catching it in time for them to be cured is often down to luck. It would be wonderful to know there was a process to check my sons regularly and that they’d be reminded with an email or a message. I don’t want it to be down to luck for them.”
One in four Black men will develop prostate cancer – double the risk of other men. To make sure the trial provides definitive evidence that will reduce their risk of dying from the disease Prostate Cancer UK will ensure that at least one in 10 of the men who are invited to participate in the trial are Black men and the charity will be working with the team to ensure this target is met. This is vital as previous trials have not included enough Black men to adequately demonstrate the harms and benefits of screening for these men – despite their significantly higher risk.
Prostate Cancer UK’s work with the National Screening Committee made it clear that to have maximum impact the men recruited into the trial must represent those who would eventually be invited into a screening programme. Therefore, the team will make the trial as accessible as possible, recruiting through GPs across the whole UK, and across the wide age group that can be expected to be screened for prostate cancer. Men will be invited from next year, although it will not be possible to volunteer.