RecruitingInterventional

Trial of Randomised Approaches for National Screening FOR Men (TRANSFORM)

The TRANSFORM study wants to find the best way to screen men early for prostate cancer in the UK. Prostate cancer is common, but often doesn't show symptoms until it's more advanced. Current tests like the PSA blood test can have downsides, such as leading to unnecessary procedures. This study is testing new approaches, like special MRI scans or saliva tests, to see if they can find serious cancers earlier while avoiding these downsides. It aims to gather strong evidence to help the NHS decide if a national screening programme is possible. Men aged 50-74 (or 45-49 for Black men and those with learning disabilities) will be invited through their GP to participate in this important research.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

16,000

Start

21 Nov 2025

Estimated completion

01 Jun 2027

Prostate cancer

What is this study about?

Each year in the UK, many men are diagnosed with prostate cancer, and sadly, a significant number die from it. The challenge is that often, prostate cancer doesn't cause any noticeable problems until it has grown or spread. Finding it early is really important because it means treatments are more likely to work.

Currently, there isn't a national screening programme for prostate cancer in the UK, unlike for some other cancers. While some tests exist, like the PSA blood test, they're not perfect. They might lead to men having further tests, like biopsies, even when they don't have dangerous cancer, or finding cancers that wouldn't have caused them any harm. The TRANSFORM study wants to change this. It's looking into newer, more promising tests, such as special MRI scans or saliva tests, that might be better at finding the serious cancers early, without causing as many unnecessary worries or treatments.

This study is a big step to help the NHS decide if and how a prostate cancer screening programme could be introduced across the country. It needs to make sure that any new screening method is not only good at finding serious cancers but also avoids unnecessary tests and treatments for men who don't need them. By taking part, you'd be helping researchers gather vital information to improve prostate cancer detection and save lives.

Key takeaways

The study aims to find the best way to screen UK men for prostate cancer.
It tests new methods like special MRI scans and saliva tests.
Men are invited through their GP practices, not by direct application.
Participation helps future prostate cancer detection for all men.
The study aims to reduce deaths from prostate cancer without causing unnecessary harm.
You can stop participating at any time.

Who may be eligible?

This study is by invitation only. If you're eligible, your GP practice will send you a letter in the post. This means you can't sign up yourself, but if you get a letter, you might be able to take part.

Generally, invitations will go to men aged between 50 and 74 years old. However, because Black men and men with learning disabilities can sometimes have worse outcomes from prostate cancer, they might be invited from a younger age, specifically from 45 years old.

There are some reasons why you wouldn't be invited. For example, if you've already had prostate cancer, or if you've had recent prostate-related tests (like a PSA blood test or an MRI scan of your prostate) in the last five years. Also, if you've had a bladder infection in the last three months, or if you have other serious health problems that might significantly shorten your life expectancy, you wouldn't be invited.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a man aged between 50 and 74 years old (or 45-49 if I am Black or have a learning disability).
I have not had prostate cancer before.
I haven't had any prostate-related tests (like a PSA blood test or prostate MRI) in the last 5 years.
I haven't had a urinary tract infection in the last 3 months.
I don't have other serious health conditions that would greatly limit my life expectancy.

Answer every question to see your result.

What does participation involve?

If you are invited and choose to take part, the study will involve different steps. In the first stage, researchers are testing four different 'Prostate Health Checks'. These checks could involve a PSA blood test, a special MRI scan (called a Prostagram™), or a saliva test to look at your genes. Depending on which check you are offered, you might have one or more of these tests.

They are also testing two different ways of running the study to see which is best. Some men might be invited to join a research group first, and then decide if they want to try one of the health checks. Others might be directly assigned to one of the health checks or a control group (who wouldn't get a health check straight away) after they agree to join. You'll be asked to provide samples like blood, urine, saliva, and stool, which will help researchers understand more about prostate cancer. The study will follow men for a long time by looking at their national health records to see if the health checks help reduce deaths from prostate cancer without causing too many unnecessary worries or procedures.

Potential risks and benefits

Most men taking part won't have prostate cancer, so they won't directly benefit from treatment for cancer, but their participation is incredibly valuable for research that could help many others in the future. Some men might find out they have prostate cancer early, which means they could get treatment sooner than they would have otherwise. However, a small number of men might be diagnosed with cancer that is already advanced. If you have a positive screening result, you might be offered a prostate biopsy. While this is a standard procedure, it does carry small risks like some blood in your urine, difficulty peeing, or an infection. Remember, you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College Healthcare NHS Trust
City only
London, England
University College London Hospitals NHS Foundation Trust
City only
London, England

Common questions

What is the main goal of the TRANSFORM study?

To find the best and safest way to screen men for prostate cancer in the UK, helping to decide if there should be a national screening programme.

Will I be directly invited to the study?

Yes, if you're eligible, you'll receive an invitation letter from your GP practice. You cannot sign up directly.

What kind of tests might be involved?

Tests could include a PSA blood test, a special MRI scan called a Prostagram™, or a saliva test to check your genes.

Will taking part guarantee I find out if I have prostate cancer?

No, the study aims to identify potential cancers, but like all screening tests, they are not 100% accurate, and most participants won't have cancer.

Who is paying for this study?

The study is funded by Prostate Cancer UK and the National Institute for Health and Care Research (NIHR).

How to find out more

Natalia Klimowska-Nassar

n.klimowska@imperial.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.