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Smarter prostate cancer screening: a blood test that may cut unnecessary biopsies

NCT ID NCT03957252

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 24, 2026

Summary

This study is testing whether a new blood test called ClarityDX Prostate can better identify men who have clinically significant prostate cancer. The test is given to men aged 40-75 with elevated PSA levels (3 ng/mL or higher) who are already scheduled for a prostate biopsy. Researchers will compare the test's predictions with actual biopsy results to see if it can reduce false alarms and unnecessary procedures.

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 blood test
What this could lead to
If successful, this test could reduce unnecessary biopsies by more accurately identifying which men with elevated PSA truly have aggressive prostate cancer.
What could go wrong
The test is still being validated and may not prove more accurate than current methods. Results from this observational study will need confirmation in future trials.

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.

Participants

About 2,800 people

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

Started

Jun 2019

Expected to finish

Jun 2027

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.

Who is studied

This prospective training and validation cohort study will consist of up to 2,800 consenting men from Alberta in addition to up to 5,000 men from external institutions, between ages 40-75 (inclusive) years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer. Only patients with Total PSA \>/= 3 ng/mL will be selected to have the ClarityDX Prostate test performed as a reflex test.

Ages

40 to 75 years

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 between 40-75 (inclusive) years of age; 2. With and without family history of prostate cancer; 3. No prior prostate cancer diagnosis and who are referred to have a prostate biopsy; 4. Total PSA results \>/= 3ng/mL collected within 6m of enrollment; 5. Willing to permit provincial agencies (e.g. Alberta Health Services, Alberta Health, Netcare, Service Alberta or other based on recruitment jurisdiction) to disclose health-related information to study; 6. Undergoing a diagnostic prostate biopsy; and 7. Provided informed consent to participate in the study. Exclusion Criteria: 1. Unwilling to participate in the study; 2. Unavailable for biopsy procedure in recruitment areas; 3. Not undergoing a prostate biopsy; 4. Prior diagnosis of cancer excluding non-melanoma skin cancer; and/or 5. Under the age of 40 years of age or over the age of 75 years of age.

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Conditions

The condition(s) this trial relates to.

disease prostate cancer

As listed by the trial registrant

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

Performance assessment of novel test Prostate cancer Prostate cancer screening

Contacts and locations

Locations

  • Johns Hopkins University

    Baltimore, Maryland, 21218, United States

  • Kipnes Urology Centre

    Edmonton, Alberta, T6G 1Z1, Canada

  • Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9, Canada

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