RecruitingNAINTERVENTIONAL

Micro-UltraSound In Cancer - Active Surveillance

This study is for men with low-risk prostate cancer who are already on 'active surveillance'. This means their cancer is being carefully watched instead of immediately treated. Researchers want to compare two types of scans: micro-ultrasound and MRI. They will use these scans to guide biopsies – small tissue samples taken from the prostate. The main goal is to find out if micro-ultrasound is better than MRI at spotting any prostate cancer that might need treatment. Participants will also have blood samples taken for future research into markers that could help detect cancer progression. The study will help doctors improve how they monitor prostate cancer.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

210

Start

30 Nov 2022

Estimated completion

30 Jul 2033

Prostate Cancer

What is this study about?

This study, called "Micro-UltraSound In Cancer - Active Surveillance," is designed for men who have been diagnosed with a very early and low-risk type of prostate cancer. Instead of having immediate treatment, many men with this type of cancer are offered 'active surveillance'. This means doctors regularly check the cancer to make sure it's not growing or becoming more serious. If it does change, then treatment might be considered.

The main purpose of this study is to compare two different ways of scanning the prostate during active surveillance: a new method called high-resolution micro-ultrasound and the more commonly used MRI (Magnetic Resonance Imaging) scan. Both of these scans can help doctors see inside the prostate. The researchers want to find out which of these scanning methods is better at spotting any important changes in the cancer that might mean it’s becoming more serious and needs attention.

To do this, participants will have biopsies, which involve taking small tissue samples from the prostate. These biopsies will be guided by both types of scans. The study will also collect blood samples. These samples won't be used immediately, but they will be stored for future research. Scientists hope these blood samples might help them discover new 'biomarkers' – substances in the blood that could help predict how prostate cancer will behave. Ultimately, this research aims to improve how doctors monitor men on active surveillance, helping them make the best decisions about their care.

Key takeaways

This study compares two scans (micro-ultrasound and MRI) for watching low-risk prostate cancer.
It's for men on active surveillance who need a follow-up biopsy.
The goal is to see which scan is better at finding important changes in the cancer.
Blood samples are for future research into new ways to track cancer.
Participation involves specific scan-guided biopsies and blood tests.

Who may be eligible?

This study is looking for adult men who have been diagnosed with a very low-risk type of prostate cancer (doctors call this Gleason Grade Group 1) and who are currently being managed by active surveillance. You would also need to be due for a follow-up prostate biopsy as part of your regular care.

However, you wouldn't be able to join the study if you cannot have an MRI scan for any reason. For example, some people can't have an MRI if they have certain metal implants in their body. You also wouldn't be able to take part if you cannot have a prostate biopsy.

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 an adult man?
Do you have low-risk prostate cancer (Gleason Grade Group 1)?
Are you currently on active surveillance for your prostate cancer?
Are you due for a confirmatory prostate biopsy?
Can you have an MRI scan?
Are you able to have a prostate biopsy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will undergo specific procedures as part of your active surveillance. Initially, you will have a micro-ultrasound scan, and then tissue samples (biopsies) will be taken from your prostate based on what the micro-ultrasound shows. After this, you will have an MRI scan, and more tissue samples will be taken based on those results. Finally, 12 standard biopsy samples will be taken from different areas of your prostate. You will also have blood samples taken. The total duration of your participation will depend on the standard active surveillance plan your doctor has set for you, particularly the timing of your confirmatory biopsy.

Potential risks and benefits

Taking part in this study may offer the benefit of potentially improving early detection methods for prostate cancer progression, which could help future patients. You will also receive careful monitoring of your prostate cancer. As with any medical procedure, there are potential risks, mainly associated with the biopsies, such as discomfort, bleeding, or infection. The study team will explain these in detail. You are free to withdraw from the study at any time without affecting your medical care.

Locations (5)

University of California Los Angeles, Department of Urology
Verified postcode
Los Angeles, United States· Recruiting
Kipnes Urology Centre - Kaye Edmonton Clinic
Verified postcode
Edmonton, Canada· Recruiting
University of British Columbia
Approximate
Vancouver, Canada· Recruiting
CIUSSS du Nord-de-L'Ile-De-Montreal
Verified postcode
Montreal, Canada· Recruiting
Humanitas
Verified postcode
Milan, Italy· Recruiting

Common questions

What is 'active surveillance'?

Active surveillance means your low-risk prostate cancer is carefully watched with regular checks, instead of immediate treatment, unless it shows signs of getting worse.

What is a micro-ultrasound?

It's a type of scan that uses sound waves to create detailed pictures of your prostate, helping doctors see very small changes.

Why are blood samples being taken?

These samples are for future research to find new 'markers' in the blood that might help predict how prostate cancer behaves, but they won't be used for your immediate care.

Will I receive extra treatment if I join?

No, this study is about monitoring your cancer with different scans and biopsies; it doesn't involve any new treatments.

Can I leave the study once I've joined?

Yes, you can leave the study at any time without giving a reason, and it will not affect your medical care.

How to find out more

Adam Kinnaird, MD, PhD

ask@ualberta.ca 780-407-5800 Official trial record

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