RecruitingNAINTERVENTIONAL

Clinical Utility of ClarityDX Prostate

This study is testing a new tool called ClarityDX Prostate for men who have been referred to a specialist because of concerns about prostate cancer. This tool uses information like blood test results (PSA levels), age, and past medical history to give a risk score. This score helps doctors and patients make better decisions about whether further tests, such as MRI scans or biopsies, are truly needed. The main aim is to see if this new tool can help reduce the number of unnecessary extra tests while still making sure that men who need treatment for serious prostate cancer are found quickly. Researchers want to see if using ClarityDX Prostate can lead to fewer unnecessary follow-up appointments and procedures. It also aims to make sure that those with a higher risk of significant prostate cancer get the right care at the right time.

At a glance

Status

Recruiting

Phase

Sponsor

Nanostics

Enrolment target

1,074

Start

14 Apr 2025

Estimated completion

01 Dec 2028

Prostate Cancer

What is this study about?

This study is looking into a new way to help men who have blood test results or other signs that might suggest prostate cancer. When you're referred to a specialist, it can be worrying, and there are often choices to be made about what to do next. This new tool, called ClarityDX Prostate, is designed to give doctors and patients clearer information to help them decide if further tests, like fancy scans (MRIs) or biopsies (where a tiny piece of tissue is removed for testing), are really necessary.

ClarityDX Prostate is not a single test but a clever way of combining different pieces of information. It can use your blood test results (like PSA levels, which can be a sign of prostate problems), your age, and whether you've had a prostate biopsy before. Sometimes, it can also include findings from a simple physical exam (DRE) or detailed results from an MRI scan. By putting all this information together, it creates a personal risk score. This score helps to show how likely it is that you might have a more serious type of prostate cancer.

The main goal of this study is to see if using ClarityDX Prostate in real-life situations can help reduce the number of men who undergo tests they don't truly need. At the same time, it aims to make sure that men who *do* have a higher risk of significant prostate cancer are identified quickly so they can get the right care without delay. This means potentially fewer anxious waits, fewer uncomfortable procedures, and more efficient use of healthcare resources.

Key takeaways

This study is testing a new tool for prostate cancer assessment.
It aims to help doctors make better decisions about further tests.
The goal is to reduce unnecessary procedures for patients.
It combines different personal medical information for a risk score.
Men referred to a specialist for prostate cancer concerns are eligible.
Participation will not affect your standard medical care.

Who may be eligible?

To take part in this study, you need to be a man aged 18 or older. You should have been referred to a urology clinic because your doctor has some concerns about prostate cancer. This means you haven't already been diagnosed with prostate cancer before, and you're willing to join the study.

It's also important that you live in an area where you can access the necessary cancer care if it's needed during or after the study. The researchers want to make sure everyone involved can get the best possible care.

You wouldn't be able to join if you're not willing to take part or if you're unable to give your consent to be in the study, for example, if you can't understand the information fully. The study is specifically for men who are suspected of having prostate cancer, not those already diagnosed.

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 been referred to a specialist because of concerns about prostate cancer?
Have you NOT been diagnosed with prostate cancer before?
Are you willing to take part in a study?
Do you have access to healthcare in your area if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of two groups: one where your doctors use the ClarityDX Prostate tool to help make decisions, and another where decisions are made using standard care practices. This is a "randomized" study, which means which group you're in is decided by chance, like flipping a coin. You'll continue with your usual appointments and tests as recommended by your doctor, but the study will observe how decisions are made and what treatments or procedures you receive.

The specific visits, assessments, and follow-up will depend on your individual situation and what your doctors recommend, based on either the ClarityDX Prostate tool or standard care. There isn't a set medication or intervention you'll be given as part of the study; instead, it's about evaluating a new way of making decisions. The total duration of your participation will depend on your prostate cancer journey and the necessary follow-up, but the study will be collecting information about your care pathway. You won't know whether the ClarityDX Prostate tool is used in your care as part of the standard practice to ensure unbiased results.

Potential risks and benefits

The main potential benefit of joining this study is that it could help improve how prostate cancer is identified and managed for everyone in the future. For you personally, if you are in the ClarityDX Prostate group, there's a chance it could help your doctors make more informed decisions, potentially leading to fewer unnecessary tests like biopsies or MRIs, while ensuring serious cancers are not missed. As with any medical study, there are no guaranteed benefits. The risks are generally low, as you'll still be receiving care that aligns with standard medical practice or a tool designed to enhance it. Your doctors will continue to make decisions in your best interest. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Prostate Cancer Centre
Verified postcode
Calgary, Canada· Recruiting
Kipnes Urology Centre
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is ClarityDX Prostate?

It's a new tool that combines different medical information to give doctors a clearer idea of a man's risk of having a serious type of prostate cancer.

How does it help doctors?

It helps doctors decide if extra tests, like MRI scans or biopsies, are really needed, potentially avoiding unnecessary procedures.

Will I get special treatment in this study?

You'll receive care that's either guided by the ClarityDX Prostate tool or standard care. The study observes decision-making rather than providing new treatments.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

What kind of information does ClarityDX Prostate use?

It uses things like your PSA blood test levels, your age, if you've had past biopsies, and sometimes results from physical exams or MRI scans.

How to find out more

Catalina Vasquez, MSc. C.Mgr.

info@nanosticsdx.com 800-672-2027 Official trial record

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