TRANSFORM trial
The £42 million TRANSFORM trial, the biggest prostate cancer screening trial in 20 years, could save the lives of thousands of men each year.
TRANSFORM begins!
The TRANSFORM trial is now open and men will begin receiving letters from their GPs inviting them to join our landmark study.
TRANSFORM is designed 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 revolutionise diagnosis by testing the most promising screening techniques available, including PSA blood tests, genetic tests and fast MRI scans, combined in ways that have never before been tested in a large-scale screening trial.
TRANSFORM 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.
Your questions, answered
What's the plan for TRANSFORM?
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.
In stage one, involving around 16,000 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.
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.
Who will be able to take part?
Invitation letters are being sent to selected men aged 45 to 74. If you are invited, you will receive more details about the study and can decide if you would like to take part. The invitation will come from your GP practice on behalf of Imperial College London. If you choose to take part, you will be asked to give your consent.
It’s crucial that the study fully reflects the UK population, so invitations to the study will be carefully controlled and it won’t 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 health records be used?
The study will also use information from NHS records for some men who:
- have not been invited
- are eligible, but do not respond.
This information will be used in a secure and confidential way. The information will provide valuable evidence for the study. You do not need to do anything unless you wish to opt out.
Don’t want your data used in TRANSFORM?
If you don’t want your health information to be used for TRANSFORM, you can opt-out at any time. To opt-out, please contact the TRANSFORM study team directly by email or post:
Email: [email protected]
Phone: 020 759 46002
Post: TRANSFORM Study Team, Imperial Clinical Trials Unit, 1st Floor, Stadium House, 68 Wood Lane, London W12 7RH
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 we have committed to ensuring that at least one in 10 of the men who are invited to participate in the trial are Black men and we’ll be working with the researchers to meet this target.
This is vital as previous trials have not included enough Black men to adequately show the harms and benefits of screening for these men.
I have three sons who will be at higher risk. It would be wonderful to know there was a process to check them regularly.
When will we start to see results from TRANSFORM?
There will be multiple points during the trial where new evidence will be generated.
We've worked closely with the UK National Screening Committee (NSC) during the development and assessment of the trial to ensure that the evidence will be complete and robust.
Separately, the massive scale of the trial will also enable the researchers 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.
How will you fund the trial?
At £42 million, TRANSFORM is the biggest single research investment ever made by Prostate Cancer UK.
TRANSFORM has been developed in consultation with, 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 our founding partners, donations from philanthropic organisations and other fundraising events.
Who advises you about the trial?
The TRANSFORM Independent Scientific Advisory Group (ISAG) will be monitoring progress and assessing the outcomes of the trial, in order to advise Prostate Cancer UK and our partnering funders, the National Institute for Health and Care Research (NIHR).
Additionally, an independent Trial Steering Committee (TSC) will be providing oversight and their relevant expertise to assist and advise the research team.
Patient and Public Involvement (PPI) representatives, who are lay volunteers with personal experience of prostate cancer, sit on both committees.
