Active not recruitingNAINTERVENTIONAL

Prostate Imaging Using MRI +/- Contrast Enhancement

This study, called PRIME, is looking at how we detect prostate cancer more efficiently. Currently, a detailed MRI scan called multiparametric MRI (mpMRI), which involves injecting a special dye, is used to find important prostate cancers. However, this type of MRI takes longer and uses more resources. We're testing a simpler, quicker MRI called biparametric MRI (bpMRI), which doesn't use the dye. The main goal is to see if this simpler bpMRI is just as good at finding important prostate cancers as the standard mpMRI. If it is, it could mean more men can get these important scans, they'll be quicker, and potentially safer as it avoids the dye.

At a glance

Status

Active not recruiting

Phase

Sponsor

University College, London

Enrolment target

500

Start

22 Mar 2022

Estimated completion

01 Mar 2025

Prostate Cancer

What is this study about?

Imagine you might have prostate cancer, perhaps because of a blood test (PSA) or a check-up. Doctors often recommend an MRI scan before a biopsy (taking small tissue samples) to help find any concerning areas in the prostate. There are different types of MRI scans.

The standard MRI for prostate cancer is called multiparametric MRI (mpMRI). This scan uses several different techniques, including one that requires an injection of a special dye into your bloodstream. This dye helps doctors see more details. While mpMRI is very good at finding serious prostate cancers, it can be time-consuming and uses up a lot of valuable hospital resources.

This study, called PRIME, is looking into a slightly different, simpler MRI called biparametric MRI (bpMRI). This scan uses fewer techniques and crucially, it doesn't require the special dye injection. Some studies suggest that this simpler bpMRI might be just as effective at finding important prostate cancers. If we can show that bpMRI is as good as mpMRI, it could mean that more men can get these important scans more quickly and easily, without needing the dye. This would be a big step forward in how we diagnose prostate cancer.

Key takeaways

Compares two types of MRI scans for prostate cancer.
Aims to see if a simpler MRI (without dye) is as effective as the standard one.
Could make prostate MRI scans quicker, cheaper, and more available.
Involves men suspected of having prostate cancer who haven't had a biopsy before.
There are no new medications involved in this study.
You can stop participating at any time.

Who may be eligible?

This study is looking for men who are at least 18 years old and have been referred to the hospital because their doctor suspects they might have prostate cancer. This suspicion could be due to a blood test (PSA) result or a physical examination. You will also need to be well enough to safely undergo all the tests and procedures involved in the study, and be able to understand and sign a consent form.

You cannot join this study if you have had a prostate biopsy before, or any past treatment for prostate cancer. You also can't join if you've already had a prostate MRI scan for your current concerns, or if there's any medical reason why you shouldn't have an MRI scan or a prostate biopsy. Essentially, if you're not medically fit for any part of the study, you wouldn't be able to take part.

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 at least 18 years old?
Has your doctor recently suggested you might have prostate cancer (e.g., due to a blood test or exam)?
Have you *never* had a prostate biopsy before?
Have you *never* been treated for prostate cancer?
Are you able to have an MRI scan and potentially a prostate biopsy safely?
Are you able to understand and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have an MRI scan of your prostate. During this scan, the doctors will initially look at your images as if they were the simpler biparametric MRI (without the dye part). After that, they will then look at the full multiparametric MRI images (including the dye part). A doctor will score any suspicious areas found on both types of scans.

Based on your MRI results, your doctors will then discuss with you whether a prostate biopsy is needed. If a biopsy is performed, small tissue samples will be taken from your prostate for examination. The total duration of your participation in the study will depend on whether you have a biopsy and subsequent follow-up, but generally involves the MRI scan and then any necessary biopsy. You won't be asked to take any new medication as part of this study.

Potential risks and benefits

Taking part could help improve future prostate cancer diagnosis for many men, offering quicker, simpler, and potentially safer scans. There are no direct personal benefits for participating beyond the standard care you would receive. Potential risks include those associated with having an MRI scan (like being in an enclosed space) and any potential very rare side effects from the special dye if it's used. If you have a biopsy, there are known risks like discomfort, bleeding, or infection. You can, of course, withdraw from the study at any time without affecting your medical care.

Locations (31)

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

Mayo Clinic
Verified postcode
Rochester, United States
NYU Langone
Verified postcode
New York, United States
Icahn School of Medicine (Mount Sinai)
Verified postcode
New York, United States
New York Presbyterian Hospital
Verified postcode
New York, United States
Centro de Urologia
Verified postcode
Buenos Aires, Argentina
Monash University
Verified postcode
Melbourne, Australia
Peter MacCallum Cancer Centre
Unverified
Melbourne E., Australia
Ghent University Hospital
Verified postcode
Ghent, Belgium
Hospital Sírio-Libanês
Verified postcode
São Paulo, Brazil
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada
Herlev and Gentofte Hospital
Verified postcode
Copenhagen, Denmark
Helsinki University Hospital
Verified postcode
Helsinki, Finland

Common questions

What is the main difference between the two MRI scans being studied?

The main difference is that one MRI (biparametric) doesn't use a special dye injection, while the other (multiparametric) does.

Why is this study important?

If the simpler MRI (without the dye) works just as well, it could make prostate cancer screening quicker, cheaper, and more accessible for men.

Will I have to have an injection?

The standard MRI being compared does involve an injection of a special dye. However, the study is hoping to show that we can get good results without it.

What happens if I decide not to participate?

Your medical care will not be affected, and your doctor will discuss standard diagnostic options with you.

What is a 'biopsy'?

A biopsy is a procedure where small tissue samples are taken from the prostate to be checked under a microscope for cancer cells.