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Smarter prostate screening: a new risk score aims to cut unnecessary biopsies

NCT ID NCT06678828

Diagnosis Sponsor: Nanostics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial is testing whether a blood-based risk score called ClarityDX Prostate can help doctors decide which men truly need an MRI or biopsy when checking for prostate cancer. The test combines standard PSA levels with age and other factors to give a personalized risk estimate. Researchers will compare men whose doctors see the test result against those who receive usual care, to see if the test reduces unnecessary procedures without missing dangerous cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ClarityDX Prostate, a blood-based risk score combining PSA levels, age, and prior biopsy history to predict clinically significant prostate cancer
What this could lead to
If successful, this test could help many men avoid unnecessary biopsies and MRIs while still catching dangerous prostate cancers early.
What could go wrong
The test is still being validated in a large trial; it may not reduce procedures as hoped or could miss some cancers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males ≥ 18 years of age 2. Referred to urology for suspicion of prostate cancer 3. No prior prostate cancer diagnosis 4. Willing to participate in the study 5. Availability for cancer care in the jurisdiction of recruitment Exclusion Criteria: 1. Unwilling to participate in the study 2. Unable to consent

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer Prostate cancer screening Prostate cancer screening decision

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kipnes Urology Centre

    Edmonton, Alberta, T6G 1Z1, Canada

  • Men's Health Clinic, Manitoba

    Winnipeg, Manitoba, Canada

  • Mount Sinai Hospital

    Toronto, Ontario, Canada

  • Prostate Cancer Centre

    Calgary, Alberta, Canada

  • Vancouver Prostate Center

    Vancouver, British Columbia, Canada

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