Not yet recruitingNAINTERVENTIONAL

Prostate Cancer Early Detection Using Serial MRI Examinations

This research, called PROCEDE, is exploring a new approach to finding prostate cancer early. Currently, decisions about prostate biopsies often rely on a single MRI scan. However, this study will look at how an unusual area on an MRI might change between two separate scans. The main aim is to see if tracking these changes over time can help doctors decide which men truly need a biopsy, and which men might not. This could mean fewer men have biopsies they don’t actually need, reduce the detection of very slow-growing cancers that wouldn’t cause problems, and ultimately help avoid treatments that aren't necessary.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

380

Start

12 Jan 2026

Estimated completion

23 Jan 2033

Prostate Cancer

What is this study about?

When doctors suspect prostate cancer, an MRI scan is often used to get a detailed picture of the prostate gland. Sometimes, these scans show areas that look a bit unusual. Traditionally, if an area looks suspicious, a biopsy might be recommended to take tiny samples from the prostate and check for cancer cells. However, biopsies can be uncomfortable and sometimes find very slow-growing cancers that wouldn't harm you.

This study, called PROCEDE, is trying a different approach. Instead of rushing to a biopsy based on just one MRI, it aims to see if looking at changes in an unusual area on two MRI scans, taken some time apart, can give doctors more information. The idea is that if an area is truly concerning, it might show changes or get bigger over time. If it stays the same, or even gets smaller, it might mean a biopsy isn't needed.

The main goal of this research is to reduce the number of men who undergo biopsies that turn out to be unnecessary. It also hopes to avoid finding and treating very slow-growing cancers that might never cause problems, which is sometimes called 'overtreatment.' By carefully observing changes on MRI scans, the study hopes to refine how we detect prostate cancer, making the process safer and more patient-friendly.

Key takeaways

This study is testing a new way to detect prostate cancer early.
It uses repeated MRI scans to track changes over time, rather than just one.
The main goal is to reduce unnecessary biopsies and overtreatment.
Participation involves regular MRI scans and monitoring.
You have the right to leave the study at any time.

Who may be eligible?

This study is looking for men aged 18 or older who are expected to live for at least another 10 years. You should not have had a previous prostate biopsy. Your PSA (Prostate-Specific Antigen) blood test result must be 20 or less. You also need to have had a recent MRI scan of your prostate that showed an area rated PIRADS 3, 4, or 5 (these are ratings doctors use to describe how suspicious an area looks). The MRI scan also needs to be clear enough to be properly read.

There are also some reasons why you wouldn't be able to join. For example, if you're already being regularly monitored for an area on your MRI (unless your last scan was very recent), or if you have certain genetic conditions or a strong family history of prostate cancer. You also wouldn't be able to join if your MRI showed no suspicious areas, or if you're taking certain medications like those for an enlarged prostate or hormone therapy that could affect the MRI results. Men with severe kidney problems or those who can't have an MRI with a special dye (gadolinium) would also not be able to participate.

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 18 or older?
Have you never had a prostate biopsy before?
Is your PSA blood test result 20 or less?
Did your recent prostate MRI show an area rated PIRADS 3, 4, or 5?
Are you able to have MRI scans, including those with a special dye?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular MRI scans of your prostate to track any changes over time. Your doctors will explain the schedule for these appointments. At each visit, you might also have blood tests and physical examinations. This study aims to reduce biopsies, so you might not have one, or it might be delayed, depending on your MRI results. You’ll be closely monitored throughout the study, and the exact total duration of your participation will depend on the study's plan for your specific case and how your MRI results change.

Potential risks and benefits

Participating in this study might offer you the benefit of avoiding an immediate prostate biopsy, potentially reducing discomfort and stress. It could also help doctors learn more about detecting prostate cancer in a less invasive way for future patients. However, there's a small risk that by delaying a biopsy, a significant cancer might be detected later. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

university Hospital Grenoble
Verified postcode
Grenoble, France

Common questions

What is a 'PIRADS' score?

PIRADS is a scoring system doctors use after a prostate MRI scan to rate how likely it is that an area on the scan contains a clinically significant cancer, from 1 (very unlikely) to 5 (very likely).

What is an 'unnecessary biopsy'?

An unnecessary biopsy refers to a biopsy that either finds no cancer or finds a very slow-growing type of cancer that would not have caused problems or needed treatment.

Will I still get treatment if needed?

Yes, if the study finds that you have prostate cancer that needs treatment, you will be offered the appropriate care. This study aims to improve detection, not to deny treatment.

What is a 'biopsy-naïve' man?

This means a man who has never had a prostate biopsy before.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, without impacting your medical care.

How to find out more

Gaelle GF FIARD, Professor

gfiard@chu-grenoble.fr 0476767971 Official trial record

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