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New blood test aims to cut unnecessary prostate biopsies

NCT ID NCT07454603

Diagnosis Sponsor: Wren Laboratories LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study is testing a new blood test called PROSTest to see if it can accurately detect prostate cancer in men with high PSA levels. Researchers will compare the test results with standard prostate biopsy findings in 1,500 men. If the test works well, it could help many men avoid the discomfort and risks of an unnecessary biopsy.

What this could mean

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

Active substance
PROSTest blood test
What this could lead to
If successful, this blood test could help many men avoid unnecessary prostate biopsies by more accurately identifying who truly has prostate cancer.
What could go wrong
This is an early observational study, not a treatment trial. The test may not be accurate enough to replace current methods, and results need confirmation in larger studies.

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 1,500 people

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

Started

Apr 2026

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

Men at risk for PCa based on age and or elevated PSA/abnormal DRE.

Ages

45 to 80 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: * elevated PSA and/or abnormal digital rectal examination Exclusion Criteria: * Previous Prostate cancer diagnosis

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Conditions

The condition(s) this trial relates to.

disease prostate cancer urinary system disorder

As listed by the trial registrant

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

Prostate cancer Prostate cancer (diagnosis) Urology

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Wren Laboratories

    RECRUITING

    Branford, Connecticut, 06405, United States

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