DiagnosticPrevention New prostate cancer screening trial could minimise the death rate

A new trial to find the best way to screen for prostate cancer is set to be led by researchers at Imperial College Healthcare NHS Trust and Imperial College London, alongside co-investigators at UCL, Queen Mary University of London and the Institute of Cancer Research.

The £42 million TRANSFORM screening trial, backed by charity Prostate Cancer UK, will bring together leading prostate cancer researchers to test new approaches that have the potential to more than double the impact of screening, and ultimately reduce prostate cancer deaths by up to 40 per cent. It is hoped that the trial could see its first results within three years.

Chief Investigator and Imperial BRC-supported investigator, Professor Hashim Ahmed, Chair of Urology at Imperial College Healthcare NHS Trust and Professor of Urology at Imperial College London, said: “This is by far the biggest, most exciting trial in prostate cancer screening and diagnosis in over 20 years. By evaluating fast MRI scans, PSA testing and genetics, we’ll finally be able to prove which is the best of the bunch when it comes to diagnosis. We will also see if they perform better in combination.”

Hundreds of thousands of men and those assigned male at birth from across the UK will be recruited to TRANSFORM, with participants invited to participate in screening from next year (2025). Patients will be invited to participate through GP surgeries and it will not be possible to volunteer.

Currently, there are more than 12,000 prostate cancer deaths in the UK alone, and this could mean thousands of lives saved each year in the UK.

Previous trials using PSA blood tests and biopsies have shown that it is possible to prevent between 8 and 20 per cent of prostate cancer deaths depending on how regularly patients are screened. But healthy people can potentially be harmed by this approach because some people with prostate cancer do not need any treatment and may undergo invasive biopsy procedures and treatments that they do not need.

Currently, 1 in 8 men will get prostate cancer in their lifetime. Men over the age of 50, who are black, or have a family history are all at increased risk. As Black men have double the risk for prostate cancer compared to other men, the study team will ensure that at least 10 per cent of patients invited to participate in the trial are Black men.

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.

Researchers will compare multiple methods of screening to find the safest, most accurate and most cost-effective method to screen for prostate cancer. The scale of the trial will also enable the team to create a biobank of samples, images and data for future research.

In the first stage of the trial, researchers will compare multiple potential screening options, including PSA blood tests, faster versions of MRI scans (known as Prostagram) 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 be taken forward to the next stage of the trial.

This first stage will recruit around 12,500 participants and take three years to complete. These findings could impact how patients are tested for prostate cancer currently.

In the second stage of the trial, researchers will recruit up to 300,000 participants to test the most promising screening methods to provide definitive evidence for the best way to screen for prostate cancer.

Participants will be followed up for at least 10 years to track how screening approaches impact both the number of lives saved, as well as patient’s quality of life and whether they experience harms associated with potentially unnecessary biopsies and treatment.

Professor Rakesh Heer, Chair of Urology at Imperial College Healthcare NHS Trust, who is part of the study team said: “TRANSFORM is not only the most important diagnosis trial in more than two decades, but it could also prove a game changer for prostate cancer research as a whole.

“The huge bank of samples, images and data from the trial will be at a scale never before seen in prostate cancer. This treasure trove will help researchers around the world create and validate innovative new tests, treatments, and AI tools. Ultimately, this will benefit scientists and clinicians everywhere, leading to better practices and helping even more men in the future.”

Dr Matthew Hobbs, Director of Research at Prostate Cancer UK, who commissioned the trial, 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.”

Professor Ahmed added: “By creating flexibility in the way we’ve designed the trial, we can incorporate promising new tests as they’re developed, future-proofing the study and making sure we design the best possible potential screening programme.

“Not only that, but the massive biobank that’s being created has the potential to drive prostate cancer research at a rate we’ve never seen before. I’m delighted to be working with Prostate Cancer UK alongside some of the best minds in prostate cancer research.”

TRANSFORM is funded by £17.5m from the NIHR and also supported by Movember.

The six lead researchers for the trial announced today represent four of the UK’s biggest research centres and will work alongside 16 co-applicants from across the country. They are: Professor Hashim Ahmed and Professor Rakesh Heer at Imperial College London and Imperial College Healthcare NHS Trust; Professor Rosalind Eeles at the Institute of Cancer Research; Professor Mark Emberton and Professor Caroline Moore at University College London; Professor Rhian Gabe at Queen Mary University of London.