The first men are being recruited to a landmark trial kicking off the biggest prostate cancer screening study in a generation. The £42m TRANSFORM screening trial is co-funded by Prostate Cancer UK (PCUK) and the National Institute for Health and Care Research (NIHR), and is the most ambitious prostate cancer study in decades.
The Government is supporting the trial with £16m of funding through NIHR. The remaining £26m is funded by PCUK through its supporters and other founding partners.
The trial’s six lead researchers represent four of the biggest UK research centres. They are from Imperial College London, the Institute of Cancer Research, University College London and Queen Mary University of London.
Prostate cancer remains the most common cancer in the UK without a screening programme. The trial is another step towards screening for all men to save as many lives as possible.
The first men are already receiving letters from their GPs, inviting them to join the trial. The study is designed to make diagnosis earlier, safer, and more effective. It will revolutionise diagnosis by testing the most promising screening techniques available. This includes PSA blood tests, genetic spit tests and fast MRI scans. They will be combined in ways that have never before been tested in a large-scale screening trial.
The opening of TRANSFORM comes as the UK National Screening Committee (NSC) is soon to announce its decision on whether current evidence supports the introduction of screening for prostate cancer in the UK. The trial goes far beyond this existing evidence, testing new ways to diagnose the disease that could find the cancers that today’s methods miss. However, the trial will also produce robust new information very son about the tests we currently use. If the NSC decides there is insufficient evidence to recommend screening now, these early results could help shift the evidence in favour of screening in as little as two years.
TRANSFORM has also been specifically designed to help tackle inequalities in prostate cancer research and care. Black men are twice as likely to get prostate cancer and twice as likely to die from it. Yet historically too few Black men have been recruited into trials to generate reliable evidence of how effective screening would be for them. To help address this, at least 1 in 10 men invited to the trial will be Black.
Those recruited at the start of the trial will form part of the initial 16,000 men taking part in stage one, which will test new techniques against the current NHS diagnostic pathway. The approaches that prove most effective will then be tested in a much larger group of up to 300,000 men, making it the biggest prostate cancer trial launched in more than two decades. The massive scale of TRANSFORM will also allow the creation of the biggest ever bank of prostate cancer samples, images and data to power the development of new tests and treatments for decades into the future. The trial will recruit men aged 50–74 (or 45–74 for some groups known to have poorer outcomes, such as Black men).
Professor Lucy Chappell, Chief Scientific Adviser at the Department of Health and Social Care (DHSC) and NIHR CEO, said: “The start of recruitment for the TRANSFORM trial marks a major milestone in prostate cancer research. The NIHR is proud to be driving this forward with PCUK and supporting this landmark study with £16 million, reflecting our confidence in the trial and our commitment to research that saves and improves lives.
"Thanks to PCUK’s leadership and the TRANSFORM team’s commitment and expertise, we will soon have the evidence we need to show the best, safest and most effective way to screen men across the UK, including black men who are at significantly higher risk of prostate cancer diagnosis."
Laura Kerby, Chief Executive at Prostate Cancer UK, said: “The future of prostate cancer screening starts today. It’s incredible to see the launch of this once-in-a-generation trial that so many people have worked to make possible, from our scientists to our amazing supporters raising funds. We’re delighted that the UK Government, through the NIHR, has partnered with us to help make TRANSFORM a success, and has committed an incredible £16m of funding. We are also incredibly grateful to all our founding partners and major donors who have got us to this exciting milestone. Now we need the public to stand up and be part of it.”
The supporting founding partners are Cockburn Shaw Legacy, Freddie Green and Family Charitable Foundation, Garfield Weston Foundation, Movember, Omaze and Paddy Power.
NIHR funding is provided through the Health Technology Assessment (HTA) Programme. HTA has initially committed £4m for the trial’s pilot stage. Further funding will be provided for the main trial if the pilot is shown to be successful.
The study is also supported by the NIHR Research Delivery Network (RDN).