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RecruitingPHASE3INTERVENTIONAL

Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.

This research study is looking at a new way to check the prostate gland called micro-ultrasound. It's being compared to the magnetic resonance imaging (MRI) scan, which is currently a common way doctors look at the prostate. The main goal is to find out if the micro-ultrasound is just as effective as MRI in spotting potential issues, especially to help decide if a prostate biopsy (taking a small tissue sample) is needed. Men aged 50 to 70 years old who haven't had a prostate biopsy before and have certain blood test results will take part. Participants will be put into one of two groups by chance, and their scan results will be compared. This study could help doctors find the best and most effective way to image the prostate.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
University of Alberta
Enrolment target
1,284
Start
08 May 2025
Estimated completion
30 Nov 2029

What is this study about?

This study is comparing two different imaging techniques used to look at the prostate gland (a small gland in men that produces fluid for sperm). One is called micro-ultrasound, which is a newer technology, and the other is the well-known MRI (Magnetic Resonance Imaging).

The main aim is to see if the micro-ultrasound scan is as good as, or even better than, the MRI scan at finding things in the prostate that might need further investigation. Both scans help doctors decide if a prostate biopsy (where a small sample of tissue is taken for examination) is necessary. The study wants to make sure we use the most effective way to check the prostate, which could lead to better decisions about follow-up care.

By comparing these two methods carefully, researchers hope to improve how doctors check for prostate conditions. This could eventually mean a more straightforward and accurate process for men who need their prostate examined.

Key takeaways

  • Compares two prostate scans: a new micro-ultrasound and standard MRI.
  • Aims to find the best way to image the prostate.
  • Could help doctors decide if a biopsy is needed.
  • Recruiting men aged 50-70 with specific blood test results or findings.
  • Participation is voluntary, you can leave at any time.
  • Contributes to important research in prostate health.

Who may be eligible?

To join this study, you need to be a man aged between 50 and 70 years old. You also need to have certain results from a blood test called a PSA, or your doctor might have felt something unusual during a prostate examination. It's important that you haven't had a prostate biopsy before.

There are also some reasons why you might not be able to join. For example, if you've already had prostate cancer or if you've had a micro-ultrasound or MRI scan of your prostate before. Also, if you can't have an MRI or micro-ultrasound for medical reasons, or if you've had certain hormone treatments in the last year, 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.

  1. Are you a man?
  2. Are you between 50 and 70 years old?
  3. Have you never had a prostate biopsy?
  4. Do you have a PSA blood test result between 3 and 20, or have your doctor feel something unusual in your prostate?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be put into one of two groups by chance – like flipping a coin. One group will have an MRI scan and the other will have a micro-ultrasound scan. You won't know which scan you'll have until you're assigned to a group. The study will mainly involve attending appointments for these scans and any related tests. The timing for these appointments will be spread out, and the total length of your involvement in the study will depend on how your results are compared with the other group. All details about your visits, what happens at each, and how long you'll be involved will be fully explained to you before you agree to participate.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to our understanding of the best imaging method for prostate health, which could help future patients. You might also receive a thorough review of your prostate health. As for risks, both MRI and micro-ultrasound are generally safe procedures, but there are always very rare potential side effects or discomforts, which will be fully explained. You will be monitored closely throughout the study. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (9)

  • University of California, Los Angeles (UCLA)
    Verified postcode
    Los Angeles, United States· Not yet recruiting
  • UT Southwestern Medical Center
    Verified postcode
    Dallas, United States· Not yet recruiting
  • University of Alberta
    Verified postcode
    Edmonton, Canada· Active not recruiting
  • University of British Columbia
    Verified postcode
    Vancouver, Canada· Not yet recruiting
  • Sunnybrook Health Sciences Centre
    Verified postcode
    Toronto, Canada· Recruiting
  • CIUSSS du Nord-de-l'Île-de-Montréal
    City only
    Montréal, Canada· Not yet recruiting
  • CH de Martigues
    Verified postcode
    Martigues, France· Recruiting
  • Vestfold Hospital Trust
    Verified postcode
    Tønsberg, Norway· Recruiting
  • Urologia Clinica Bilbao
    Verified postcode
    Bilbao, Spain· Recruiting

Common questions

What is micro-ultrasound?

It's a new type of scan that uses sound waves, similar to a regular ultrasound, but with much higher detail to look at your prostate gland.

What is an MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed pictures of the inside of your body, including your prostate.

Why is this study important?

It helps doctors find the best way to look at the prostate, which can lead to better decisions about whether tests like biopsies are needed.

Will I know which scan I will have?

You will be assigned to either the MRI or micro-ultrasound group by chance, so you won't choose which scan you receive.

What if I change my mind about participating?

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

How to find out more

Stacey Broomfield, PhD

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 "Screening for Prostate Cancer Using High Resolution Micro-ul…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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