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RecruitingNAINTERVENTIONAL

Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System

This study is looking at a new artificial intelligence (AI) system designed to help doctors find more significant prostate cancers (ISUP≥2) using special MRI scans. Currently, prostate MRI helps identify suspicious areas before a biopsy, but it doesn't always pinpoint the most important cancers accurately, and different doctors might interpret scans differently. Researchers have developed an AI tool that has shown promise in initial tests. Now, they want to check if this AI works well when used in different hospitals and with different MRI machines. The study will involve men who are having an MRI and a prostate biopsy because there's a suspicion of prostate cancer, to compare how well the AI system performs against the traditional way doctors read the scans.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Hospices Civils de Lyon
Enrolment target
420
Start
14 Apr 2021
Estimated completion
15 Jun 2026

What is this study about?

When there's a concern about prostate cancer, doctors often recommend a special MRI scan called a multiparametric MRI (mpMRI). This scan helps them look for suspicious areas in the prostate before deciding where to take tissue samples (biopsies). The idea is to guide the biopsy needles precisely to areas that might contain cancer. However, reading these MRI scans can be tricky. Sometimes, the scans might show something suspicious that isn't actually a serious cancer, or different doctors might interpret the same scan slightly differently. This means it's not always easy to consistently find the more aggressive cancers that need treatment while avoiding unnecessary biopsies for less serious findings.

To improve this, researchers have been developing a new type of computer program, often called an Artificial Intelligence (AI) system. This AI system has been taught to recognise patterns in MRI images that could indicate important prostate cancers (specifically those graded ISUP≥2, which are generally more serious). Early tests of this AI have been positive, but these tests were done using MRI scans from a single hospital and its specific machines.

This study, called CHANGE, is designed to see if this new AI system works just as well in a wider range of real-world settings. It will involve many different hospitals and various MRI machines. By collecting MRI scans and biopsy results from men across different locations, the researchers can properly test if the AI system can consistently help doctors spot serious prostate cancers, regardless of where the MRI was done. The ultimate goal is to see if this AI can be a valuable tool to make prostate cancer detection more accurate and reliable, helping doctors make better decisions about care.

Key takeaways

  • This study is testing a new AI system to improve prostate cancer detection.
  • It aims to find more significant prostate cancers using MRI scans.
  • The study compares the AI system's performance to current doctor-reviewed MRI scans.
  • Participation involves your standard MRI and biopsy appointments, plus a blood sample and questionnaire.
  • The goal is to develop better tools for future prostate cancer diagnosis.

Who may be eligible?

This study is looking for men aged between 18 and 80 years old. You might be suitable if you're being referred for a prostate MRI scan followed by a biopsy, either for the first time or if you've had previous biopsies that didn't find cancer. Your PSA level (a blood test marker for prostate health) should be 30 ng/ml or less, and your doctor should not have found signs of advanced prostate cancer during a check-up.

There are several reasons why you might not be able to join the study. For example, if you are older than 80, or your PSA is higher than 30 ng/ml. You also can't participate if you've already had prostate cancer diagnosed or treated, or if you've had radiation therapy to your pelvis. If you've had a prostate biopsy in the last 12 months, or if you have certain types of hip replacements or other reasons making an MRI or biopsy unsafe, you also won't be able to join. Finally, if you don't understand French, as the study is run in France, you wouldn't 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.

  1. Are you a man aged between 18 and 80?
  2. Are you having a prostate MRI and possibly a biopsy for the first time, or after previous negative biopsies?
  3. Is your PSA level 30 ng/ml or less?
  4. Have you NOT had prostate cancer diagnosed or treated before?
  5. Have you NOT had a prostate biopsy in the last 12 months?
  6. Do you NOT have serious conditions preventing an MRI or biopsy (e.g., certain hip replacements, other contraindications)?
Answer every question to see your result.

What does participation involve?

If you join this study, you will go through the usual steps you would normally take for prostate cancer investigations. This includes having a multiparametric MRI scan of your prostate and then biopsies if recommended by your doctor. The study will collect a blood sample from you, which is used for research purposes. You will also be asked to complete a follow-up questionnaire at some point. The main difference is that the MRI images will also be reviewed by the new Artificial Intelligence system being tested, alongside your doctor's assessment. You won't need any extra visits or changes to your standard medical care as part of this study, and the total duration would align with your usual diagnostic pathway.

Potential risks and benefits

Participating in this study might offer the benefit of contributing to new knowledge that could improve prostate cancer detection for future patients. While there are no direct medical benefits to you from the experimental part of the study, your MRI and biopsy will be managed as part of your standard care. The risks involved are those associated with having a prostate MRI and biopsy, which your doctor will explain. There are no additional risks directly from the study's research component beyond standard care, as it involves reviewing your existing images. You are free to withdraw from the study at any time without affecting your medical care.

Locations (17)

  • Department of radiology and urology, CHU Pellegrin
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • Department of urology and Radiology, CHU Grenoble Alpes
    Verified postcode
    Grenoble, France· Not yet recruiting
  • Department of radiology and urology, CHU de Lille
    Verified postcode
    Lille, France· Not yet recruiting
  • Department of radiology and urology, Hôpital Edouard Herriot
    Verified postcode
    Lyon, France· Recruiting
  • Department of radiology and urology, Hôpital Saint Joseph Saint Luc
    Verified postcode
    Lyon, France· Not yet recruiting
  • Department of Radiology and Urology, Hopital Européen Marseille
    Verified postcode
    Marseille, France· Not yet recruiting
  • Department of Radiology and Urology, Institut Paoli-Calmettes Marseille
    Verified postcode
    Marseille, France· Not yet recruiting
  • Department of Urology, Clinique Beausoleil Montpellier
    Verified postcode
    Montpellier, France· Not yet recruiting
  • Department of urology and Radiology
    Verified postcode
    Montpellier, France· Not yet recruiting
  • Department Urology, Clinique urologique Nantes Atlantis
    Verified postcode
    Nantes, France· Not yet recruiting
  • Department of radiology and urology, Hôpital la Pitié Salpêtrière
    Verified postcode
    Paris, France· Not yet recruiting
  • Department of radiology, Hôpital Necker
    Verified postcode
    Paris, France· Not yet recruiting

Common questions

What is an 'ISUP≥2 Prostate Cancer'?

This refers to prostate cancers that are considered more significant or aggressive, and often require treatment. ISUP is a grading system doctors use to classify how aggressive a cancer looks under a microscope.

What is an MRI and why is it used for prostate cancer?

MRI (Magnetic Resonance Imaging) is a type of scan that uses strong magnets and radio waves to create detailed pictures inside your body. For prostate cancer, it helps doctors see suspicious areas in the prostate that might need a closer look with a biopsy.

What is Artificial Intelligence (AI) in this study?

AI here is a computer program designed to learn from many prostate MRI scans. It helps doctors by highlighting areas on a scan that might suggest a serious prostate cancer, potentially making detection more accurate.

Will the AI system make decisions about my treatment?

No, the AI system is a tool to help doctors. Your doctor will always make the decisions about your care and treatment based on all the information available, including the MRI, biopsy results, and their own expertise.

What is PI-RADS and why is it mentioned?

PI-RADS is a standard scoring system that doctors use to interpret prostate MRI scans. It helps them rate how likely it is that a suspicious area shows important cancer. This study is comparing the new AI system to how doctors use the PI-RADS scoring system.

How to find out more

Olivier ROUVIERE, Pr

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

Interested in taking part?

Register your interest

Share your details and the research team for "Detection of ISUP≥2 Prostate Cancers Using Multiparametric M…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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