RecruitingInterventional

A clinical trial to find out if using the findings from PSMA PET scans to escalate treatment can improve cancer control in patients with high-risk prostate cancer

This study, run by Imperial College London and funded by Prostate Cancer UK, is investigating if a new type of scan, called a PSMA PET-CT, can improve treatment outcomes for men recently diagnosed with high-risk prostate cancer. Currently, doctors use CT and bone scans to see if the cancer has spread. In this study, some men will have their treatment guided by the standard scans, while others will have their treatment guided by the PSMA PET-CT results. Researchers want to find out if using the PSMA PET-CT leads to better control of the cancer. Participants will be randomly placed into one of these two groups. The study will run from February 2026 to November 2031, aiming to help improve future prostate cancer care.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

476

Start

02 Feb 2026

Estimated completion

06 Feb 2028

Prostate cancer

What is this study about?

This study is looking into whether using a special type of scan, called a PSMA PET-CT, can help doctors make better decisions about treatment for men who have been recently diagnosed with high-risk prostate cancer. When you're first diagnosed, doctors usually use regular scans like CT scans and bone scans to see if the cancer has spread outside the prostate. This study wants to find out if the PSMA PET-CT scan can give a clearer picture, and if using this information to guide treatment leads to better results for patients.

To do this, the study will compare two ways of guiding treatment. Some patients will have their treatment planned using only the results from the standard CT and bone scans, just like current NHS practice. Other patients will have their treatment planned using only the results from the PSMA PET-CT scan. By comparing these two groups, researchers hope to learn if one approach is more effective at controlling the cancer.

The goal of this research is to see if incorporating PSMA PET-CT into standard care could improve treatment for future patients with high-risk prostate cancer. It's an important step in trying to find the best way to manage this condition.

Key takeaways

Compares a new scan (PSMA PET-CT) with standard scans for high-risk prostate cancer.
Aims to see if the new scan guides better treatment decisions.
Participants will be randomly assigned to one of two treatment guidance groups.
Could help improve future prostate cancer care for all men.
Involves extra scans, which use a small amount of radiation.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for men aged 18 and over who have recently been diagnosed with high-risk prostate cancer. High-risk means your cancer has certain features that make it more likely to spread, such as a higher grade or a higher PSA level, or if it appears to be growing outside the prostate on scans.

You should also be suitable for standard treatments for your prostate, like surgery or radiotherapy, as decided by your doctors. Also, a recent MRI scan should show that your cancer is currently only in the prostate or nearby areas, and hasn't obviously spread to other parts of your body.

You cannot join if you've already had treatment for prostate cancer (except certain medications like a 5-alpha reductase inhibitor), or if your cancer has already spread to other parts of your body according to your MRI scan. You also can't take part if you have other serious health conditions, certain allergies, or if you can't have the specific scans required for the study.

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.

Are you an adult male (18 years or older)?
Have you recently been diagnosed with high-risk prostate cancer?
Has an MRI scan shown your cancer is currently only in the prostate or nearby area?
Are you suitable for standard prostate treatments like surgery or radiotherapy?
Have you NOT already received treatment for prostate cancer (excluding certain medications)?
Can you have MRI, CT, bone scans, and PSMA PET-CT scans?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will have three types of scans: a CT scan, a bone scan, and a PSMA PET-CT scan. These scans use a small amount of radiation to create detailed pictures inside your body. After all these scans are done, you will be randomly placed into one of two groups, like flipping a coin – you'll have an equal chance of being in either group.

If you're in Group 1, your doctors will only see the results from your CT and bone scans to plan your treatment, which is the standard way things are done on the NHS. If you're in Group 2, your doctors will only see the results from your PSMA PET-CT scan, and your treatment will be planned based on those results. To make sure the study gives clear answers, you won't be able to see the results of all your scans until about 51 months (over 4 years) after you agree to join the study.

Some of these scans might be extra compared to what you would normally have. Each scan involves an injection into a vein in your arm, which might cause mild bruising. The study is expected to run from February 2026 to November 2031, but your personal involvement and follow-up will depend on your treatment plan.

Potential risks and benefits

There might not be direct benefits for you personally by taking part in this study. However, some patients in the PSMA PET-CT group might have cancer spread detected earlier, although we don't know if this will change your overall treatment outcome. The information gathered from this study could be very valuable and help improve treatment for many prostate cancer patients in the future. The main risks involve the scans. These scans use a small amount of radiation, which carries a very small chance (about 0.6%) of causing cancer many years later. The injections for the scans can also cause minor bruising. It's important to remember that no scan is perfect; they can sometimes miss cancer or show something that isn't cancer. You can choose to stop participating in the study at any time, for any reason, without affecting your standard care.

Locations (1)

Charing Cross Hospital
Approximate
London, England

Common questions

What is 'high-risk' prostate cancer?

High-risk means your cancer has certain features, like a higher grade or PSA level, or looks to be growing outside the prostate, suggesting it might spread more easily.

What is a PSMA PET-CT scan?

It's a specialized scan that can sometimes find prostate cancer cells more accurately than standard scans by detecting specific markers on the cancer cells.

Why can't I see all my scan results right away?

This is to make sure the study results are accurate. If doctors saw all results, it could affect how they treat you, making it hard to compare the two groups fairly.

Will I still get my usual NHS care?

Yes, even if you are in the study, any standard treatment you receive will follow NHS guidelines, guided by the specific scan results allocated to your group.

Who is paying for this study?

The study is funded by Prostate Cancer UK, a charity dedicated to supporting men with prostate cancer.

How to find out more

Samuel Morris

s.j.morris@imperial.ac.uk - Official trial record

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