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Simple blood test could spare prostate cancer patients from repeat biopsies

NCT ID NCT04052048

Diagnosis Sponsor: Immunis.AI 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is testing a non-invasive blood test that looks at RNA patterns to see if a man's prostate cancer is becoming more aggressive. It involves 2,000 men on active surveillance for low-risk prostate cancer. The goal is to see if the blood test can reliably detect dangerous changes, potentially reducing the need for repeated invasive biopsies.

What this could mean

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

Active substance
Subtraction Normalized Expression of Phagocytes Blood Test (a non-invasive blood test that analyzes RNA to detect aggressive prostate cancer)
What this could lead to
If successful, this blood test could help men with low-risk prostate cancer avoid unnecessary repeat biopsies by accurately detecting if their cancer becomes more aggressive.
What could go wrong
This is an observational registry study, not a treatment trial. The test is still being validated, and it may not be accurate enough to replace biopsies in all cases.

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 2,000 people

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

Started

Sep 2019

Expected to finish

Sep 2029

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 with prostate cancer who are on or are candidates for Active surveillance.

Ages

40 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 * Men between 40-80 of age with at least a 10-year life expectancy * All active surveillance protocols are accepted * No PSA limits Category 1: * Patient is currently on active surveillance with only ONE previous low grade prostate biopsy. * Patient must already be scheduled for their 1st annual biopsy under their active surveillance protocol within 90 days of enrollment date. Category 2: • Patient is recently diagnosed with low grade prostate cancer but has decided against active surveillance and is scheduled for radical prostatectomy within 90 days of enrollment date. Exclusion Criteria: Men on watchful waiting i.e. those with less than 10-year life expectancy with no intent for curative therapy * Men with symptoms or rising PSA who have not been proven to have cancer by tissue biopsy i.e. men with only negative prostate biopsies. * Patients with a history of a different cancer (except basal cell carcinoma)

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate cancer, hereditary, 7

As listed by the trial registrant

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

Prostate cancer aggressiveness

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

  • Comprehensive Urology

    RECRUITING

    Royal Oak, Michigan, 48197, United States

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