CompletedInterventional

A comparison of two treatments to reduce prostate size and symptoms in men with benign enlargement

This study is for men aged 50 and over with an enlarged prostate, a common condition causing urinary issues. It compares two methods of a procedure called prostate artery embolisation (PAE), which helps shrink the prostate. One method uses tiny plastic beads (microspheres), which is the standard treatment. The other uses a new medical glue. Researchers want to see if the glue is as safe and effective, and if it offers benefits like quicker procedures or longer-lasting results. Participants will be randomly assigned to receive one of these treatments and will be monitored for up to four years to see how well they work and if there are any side effects. The goal is to find the best way to help men with this condition.

At a glance

Status

Completed

Sponsor

University Hospitals Dorset NHS Foundation Trust

Enrolment target

300

Start

02 Jun 2025

Estimated completion

03 Mar 2026

Prostate artery embolization

What is this study about?

When men get older, it's very common for their prostate gland to get bigger. This condition is called benign prostate enlargement (or BPE for short). While it's not cancer, it can cause bothersome problems like needing to pee more often, having trouble starting or stopping, or feeling like your bladder isn't completely empty. One way doctors can treat BPE is with a procedure called prostate artery embolisation (PAE). This works by carefully blocking the small blood vessels that supply the prostate, which helps to shrink it.

Currently, PAE usually involves using tiny plastic particles, called microspheres, to block these blood vessels. This study is testing a new approach: using a special medical glue instead of microspheres. Doctors want to find out if this glue is just as good, or even better, at shrinking the prostate and easing symptoms. They'll be looking at things like how safe it is, whether it might make the procedure quicker, or if its effects could last for a longer time.

By comparing these two methods, the study hopes to improve the options available for men with BPE. The information gathered will help doctors understand which treatment works best for different patients, potentially leading to better and more personalised care in the future for a condition that affects many men.

Key takeaways

Compares two PAE methods for enlarged prostate.
Investigates new medical glue versus standard tiny particles.
Aims for better prostate shrinkage and symptom relief.
Participants aged 50+ with BPE are needed.
Follow-up lasts up to 4 years, with closer monitoring initially.
Your care won't be affected if you choose to leave the study.

Who may be eligible?

This study is looking for men aged 50 or older who have been diagnosed with an enlarged prostate (BPE) and have been told by their NHS specialist that they could have the PAE procedure.

To join, you must have moderate to severe urinary symptoms related to your enlarged prostate. The study team will check if you meet all the specific requirements to make sure the treatment is right and safe for you. For example, you can't have had certain prostate surgeries or treatments in the last year, or have certain other medical conditions.

The research team will go through all the details with you at your clinic appointment to confirm if you are suitable. You must also be able to understand English well enough to follow the study instructions and fill out questionnaires.

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 a man aged 50 or over?
Have you been diagnosed with an enlarged prostate (BPE) causing urinary problems?
Has your NHS specialist suggested prostate artery embolisation (PAE) for you?
Have you NOT had prostate surgery or certain other prostate treatments in the last year?
Are you able to speak and understand English well enough to complete questionnaires?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have a clinic appointment. Here, your medical history will be checked, some basic health measurements will be taken, and you'll complete questionnaires about your urinary and sexual health. These questionnaires are important because they help the doctors understand your symptoms before the treatment.

Then, you'll be randomly assigned to receive one of two types of prostate artery embolisation (PAE) – either the standard treatment using tiny plastic particles or the new treatment using medical glue. You won't know which one you receive. The procedure itself involves a doctor inserting a thin tube into a blood vessel, usually in your wrist or groin, and guiding it to block the blood supply to your prostate. After the procedure, you'll have follow-up check-ups for up to four years, with most contact happening in the first six months. These check-ups will involve clinic visits and calls or online questionnaires to see how you're feeling and if your symptoms have improved. You might also have scans if they are part of your usual care.

You are completely free to leave the study at any time, and this will not affect your medical care in any way. Any information collected up to that point would still be useful for the study.

Potential risks and benefits

If you take part, you might find that your urinary symptoms from your enlarged prostate get better, though this isn't guaranteed for everyone. The information gathered from your experience, whether your symptoms improve or not, will help doctors learn which treatment works best for future patients. Prostate artery embolisation (PAE) is a common procedure, and like all medical treatments, it has some known risks. These can include pain where the tube was inserted, feeling unwell afterwards (like flu-like symptoms or discomfort in your pelvis), temporary difficulty peeing, urine infections, or blood in your urine. More serious problems are rare, and the study team will monitor you very closely. The medical glue being tested has been safely used in other parts of the body, but using it for PAE is newer, so doctors are keen to understand its safety and effectiveness specifically for this use.

Locations (11)

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

University Hospitals Dorset NHS Foundation Trust
City only
Poole, United Kingdom
University Hospital Southampton NHS Foundation Trust
City only
Southampton, United Kingdom
Royal Berkshire NHS Foundation Trust
City only
Reading, United Kingdom
Oxford University Hospitals NHS Foundation Trust
City only
Oxford, United Kingdom
Guys and St Thomas' NHS Foundation Trust
City only
London, United Kingdom
Imperial College Healthcare NHS Trust
City only
London, United Kingdom
University College London Hospitals NHS Foundation Trust
City only
London, United Kingdom
Manchester University NHS Foundation Trust
City only
Manchester, United Kingdom
North Bristol NHS Trust
City only
Bristol, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
City only
Birmingham, United Kingdom
The Christie NHS Foundation Trust
Unverified
Manchester, United Kingdom

Common questions

What is prostate artery embolisation (PAE)?

PAE is a procedure that blocks the blood flow to your prostate to help shrink it and ease urinary problems caused by an enlarged prostate.

Why is this study comparing two treatments?

The study aims to see if a newer medical glue works better or has advantages over the standard treatment (tiny plastic particles) for prostate artery embolisation.

Will I know which treatment I receive?

No, you won't know whether you receive the medical glue or the standard plastic particles. This helps ensure fair results for the study.

How long will I be involved in the study?

Each participant will be monitored for up to 4 years after their treatment, with the most frequent check-ups in the first 6 months.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

James Coulton

james.colton@uhd.nhs.uk - Official trial record

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