Not yet recruitingNAINTERVENTIONAL

Comparing pOrtable MRI and TRUS-Fusion Prostate Biopsy to Assess aCcuracy of Prostate Cancer Detection

This study is looking at a new way to find prostate cancer using a portable MRI scanner. Currently, prostate biopsies often involve an MRI scan followed by an ultrasound-guided biopsy, which can be complex and time-consuming. This new portable MRI could make the process quicker, potentially allowing scans and biopsies to happen in one visit. Researchers want to compare the accuracy of biopsies guided by this portable MRI machine with the standard ultrasound-guided biopsies. Eighty-five men suspected of having prostate cancer will participate, undergoing both types of biopsies. The main goal is to see if the portable MRI method is practical to use and how well it detects cancer.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

01 Mar 2025

Estimated completion

01 Jul 2027

Prostate Cancer

What is this study about?

When doctors suspect someone might have prostate cancer, they usually recommend an MRI scan first. If the MRI shows any areas that look suspicious, they then take small tissue samples, called biopsies, from those areas. Normally, this involves a second procedure where an ultrasound scan helps guide the biopsy needle to the suspicious spots identified in the earlier MRI. This process often takes several steps and involves different equipment, which can be a bit complicated.

This study is looking at a new, smaller MRI machine that's portable. Think of it like a special MRI that can be used directly in a clinic room or operating theatre. What's special about it is that biopsies could be taken with the guidance of this portable MRI directly, potentially in one visit. This could mean fewer appointments, less travel, and a more straightforward process for patients. The machine also uses a weaker magnet, which means fewer special safety precautions are needed compared to a large hospital MRI.

Researchers want to find out how well this new portable MRI-guided biopsy works compared to the current standard biopsy method. They want to see if it's just as good at finding cancer, or even better, and if it makes the whole diagnostic journey easier and more accurate. This information will help doctors decide if this new technology should become a standard way of diagnosing prostate cancer in the future.

Key takeaways

New study comparing portable MRI biopsy with standard ultrasound biopsy.
Aims to improve prostate cancer diagnosis process.
Involves 85 men with suspected prostate cancer.
Participants will undergo both biopsy methods in one procedure.
Results will help evaluate the new portable MRI technology.

Who may be eligible?

To join this study, you need to be at least 18 years old and a man. You would also need to have a higher-than-normal PSA level for your age, which is a blood test marker that can suggest prostate problems. Additionally, an earlier prostate MRI scan must have shown some suspicious areas (scored as LIKERT/PIRADS 3 or higher) for which your doctor has already recommended a biopsy.

There are some reasons why you wouldn't be able to join. For example, if you can't have a regular MRI scan because you have certain metal implants, foreign objects, or medical devices in your body (like a cardiac pacemaker or a special defibrillator). You also can't take part if there's a medical reason you can't have a biopsy guided by an ultrasound probe, or if you're unable to understand the study information and give your permission to join.

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 18 years old or older?
Do you have a raised PSA level for your age?
Has your doctor recommended a prostate biopsy based on a suspicious MRI scan (LIKERT/PIRADS 3 or higher)?
Are you able to have a standard MRI scan and a prostate biopsy?
Are you able to understand the study information and give your consent?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you'll first be contacted by a member of the study team. They will explain the study in detail and provide written information for you to read. You'll have time to think about it before giving your consent, which can be done over the phone or in person. You'll then be asked to complete some questionnaires, either online or on paper, about your urinary, bowel, and sexual health, as well as your general well-being.

Next, you'll have a combined biopsy procedure. This can be done with a local anaesthetic (to numb the area), or if you prefer, under sedation or a general anaesthetic (where you're asleep). During this single procedure, both the standard ultrasound-guided biopsy and the portable MRI-guided biopsy will be performed. Each suspicious area in your prostate will have 6 samples taken, with 3 samples using each biopsy method. The order in which these two biopsy methods are used will be decided randomly, like flipping a coin, to ensure fairness. After the biopsy, you'll have an appointment, either in person or remotely, to discuss your biopsy results with the medical team. The total duration of your active participation will involve these steps up to receiving your results.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as receiving state-of-the-art diagnostic testing for your prostate cancer suspicion, which might include new technology. However, it's important to remember that this is a research study, and the main goal is to gather information, not necessarily to provide you with direct personal benefit. As with any medical procedure, there are potential risks associated with biopsies, such as discomfort, bleeding, or infection. The doctors will explain these risks fully before you give your consent. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Imperial College London
Verified postcode
London, United Kingdom

Common questions

What is a 'portable MRI'?

It's a smaller MRI machine that can be used more flexibly in clinic rooms, aiming to make biopsies quicker and potentially more accurate.

Will I have more biopsies than I would normally?

No, you will have the same total number of biopsy samples taken as per the standard procedure in your local hospital, but these will be split between two guidance methods.

Will I be awake during the biopsy?

You can choose to have the biopsy with local anaesthetic (you're awake but the area is numb), or under sedation or general anaesthetic (where you're asleep).

What is 'randomised 1:1'?

This means the order of the two biopsy types (portable MRI vs. standard ultrasound) will be decided by chance, like a coin toss, for fairness.

What do LIKERT/PIRADS scores mean?

These are scoring systems used by doctors to describe how suspicious an area on your prostate MRI looks for cancer.

How to find out more

Taimur Shah, Dr

t.shah@imperial.ac.uk 020 3311 6611 Official trial record

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