TRANSFORM trial

TRANSFORM update, May 2024

Prostate Cancer UK is launching a £42 million research programme – the TRANSFORM trial – to find the best way to screen men for prostate cancer, so one day all men at risk are invited for regular tests to find aggressive cancers in time for a cure.

It will be the biggest trial in prostate cancer screening for 20 years and has been developed in consultation, and with the backing of, the NHS, the National Institute for Health and Care Research (NIHR) and the UK Government, who have committed to contribute £16 million. The study is also being supported by founding partners Movember and the Freddie Green and Family Charitable Foundation, in addition to other significant donations from philanthropic organisations.

The TRANSFORM trial, involving hundreds of thousands of men, will compare the most promising tests and provide definitive evidence about the best way to screen for prostate cancer. This is urgently needed. 12,000 men die of prostate cancer each year. It is the most common cancer in the UK without a screening programme, even though it usually has no symptoms until it has spread and become incurable.

With decades of research-funding experience, we’ve brought together the best researchers globally and engaged independent experts to make sure the trial is robust enough and can provide the insight needed to revolutionise prostate cancer diagnosis.

Following on from our announcement in November that the trial is taking place, we can now share more details of the trial – including the lead researchers working on the study and the tests being investigated.

Your questions, answered

When will the trial start?  

The researchers will start setting up the trial in spring 2024, and will start recruiting men to the trial later in the year.

When will we start to see results from TRANSFORM?

There will be multiple points during the trial where new evidence will be generated that might lead to a screening programme. The first point at which we will see significant new evidence will be around three years after it begins.

We have worked closely with the UK National Screening Committee (NSC) during development and assessment of the trial to ensure that the evidence will be complete and robust. The NSC has committed to assessing evidence as it is published throughout the trial rather than waiting right until the end for final data to be published as some of this data takes many years to accrue.

Separately, the massive scale of the trial will also enable the team to collect a bio bank of samples, images and data at a scale never seen before in prostate cancer. This will be available to all kinds of cancer researchers and is predicted to spur a wave of new discoveries and provide proof for the next generation of diagnostics.

Who will carry out the research?

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.

Professor Hashim Ahmed, Chair of Clinical Urology at Imperial College London. A researcher and clinician who studies how biopsies, imaging techniques and treatments can be improved for men with prostate cancer.

Professor Ros Eeles, Professor of Oncogenetics at The Institute of Cancer Research, London. A geneticist who has helped find more than 160 genetic differences that contribute to a man’s risk of prostate cancer.

Professor Mark Emberton, Professor of Interventional Oncology at University College London. Working to improve diagnosis and treatment for men using new imaging techniques and less invasive treatments.

Professor Rhian Gabe, Professor of Biostatistics and Clinical Trials at Queen Mary University of London. A statistician with expertise in clinical trials as well as cancer screening, prevention and early detection.

Professor Rakesh Heer, Chair of Urology at Imperial College London. A surgeon and researcher with a focus on urological cancers and expertise spanning stem cells and basic biology to robotic surgery and clinical trials.

Professor Caroline Moore, NIHR Research Professor and Head of Urology at University College London. Specialising in using MRI scanning to detect and treat prostate cancer, and personalising men's journeys from screening to treatment.

What exactly will be tested in the trial?

TRANSFORM will compare multiple screening options to each other and the current system, to find the safest, most accurate and most cost-effective way to screen men for prostate cancer. The massive scale of the trial will also enable us to collect a hugely important ‘bio bank’ of data and images to help drive new discoveries and validate next generation methods of diagnosis.

In stage one, involving around 12,500 men, researchers will compare four potential screening options, including fast MRI scans, genetic testing to identify men at high risk of prostate cancer, and PSA blood testing. A fast MRI is a 12-minute version of the full scan that uses magnetic resolution imaging (MRI) to produce a detailed picture of the prostate.

These approaches will also be compared to a control group, where men will follow the current NHS process – in other words, they won’t be offered a PSA test, but can request one. A control group is vital to prove that any screening programme is more effective than the current process.

In stage two, involving up to 300,000 men, the researchers will test the most promising option, or options, from stage one to see how well this screening method detects cancer as well as any harms it causes – for example, if men are more likely to be treated, and therefore experience side effects, for a cancer that won’t affect them in their lifetimes.

Men will also be followed up for at least a decade after to see how their prostate cancer affects them.

How will you fund the trial?

The funding for this £42m programme of research will come from a variety of sources, including government funding, partnerships, and philanthropic donations.

Due to the large commitment from the NIHR and our partners to date, we are confident that we will unlock additional sources of funding required to deliver this ground-breaking trial. We have also secured a foundational commitment of £1.5m towards this trial from Movember through our longstanding partnership.

We know that there is always more good quality research in need of funding, and will continue our ambitious programme of fundraising to ensure we can fund as much critical research as possible.

Who will be able to take part in the trial?

The trial is not yet open for recruitment. Men between 50 and 75, or from the age of 45 for Black men, may receive a letter via their GP from next year inviting them to participate in TRANSFORM.

It is crucial that we make sure that the study is fully reflective of the UK population and of current practice in the UK, so invitations to the study will be carefully controlled and it will not be possible to volunteer. However, if you do receive a letter from your GP about the TRANSFORM study then we strongly encourage you to take part.

Will Black men be recruited to the trial? How will you ensure the trial is diverse?

1 in 4 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 has committed to ensuring 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.