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New blood test aims to sharpen prostate cancer detection

NCT ID NCT07543757

Diagnosis Sponsor: Sequenom, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 3 times

Summary

This study is testing a blood test called Proclarix to see if it can better identify men with aggressive prostate cancer before they have a biopsy. About 500 men aged 40-75 with certain PSA levels will give a blood sample before their scheduled biopsy. The test results will be compared to the biopsy findings to see how accurate it is at ruling out serious cancer.

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 500 people

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

Started

Apr 2026

Expected to finish

Mar 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

1. Previous diagnosis of prostate cancer; 2. Treatment with a medication classified as a 5α-reductase-inhibitor at any time in the 6 months prior to study blood draw; 3. Acute or chronic urinary tract infection within 3 months of the Screening Visit; 4. Men with an indwelling catheter or intermittent self-catheterization; 5. Digital Rectal Exam (DRE) or transurethral manipulation (e.g. cystoscopy, catheterization) the same day and prior to the Screening Visit blood draw; 6. Men who had an invasive urological procedure for benign prostate hyperplasia/obstruction (e.g. transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), Thulium laser enucleation of the prostate (ThuLEP), aquablation, prostatic artery embolization, Rezum, laser vaporization, etc.) or biopsy of the prostate 6 months prior to the Screening Visit blood draw; 7. Subject is not able to read and comprehend English or Spanish; or 8. Previous enrollment in this protocol.

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. Subject is male ≥40 and ≤75 years of age at the time of enrollment; 2. Subject provides a signed and dated informed consent; 3. Subject has a SOC tPSA of 2-10 ng/mL inclusive within 30 days of the Screening Visit; 1. Up to 100 subjects will have a SOC tPSA of 2-\<4 ng/mL 2. A minimum of 400 subjects will have a SOC tPSA of 4-10 ng/mL 4. Subject is scheduled to undergo a prostate biopsy within 30 days of the Screening Visit blood collection; 5. Subject agrees to provide all diagnostic test results throughout the study; and 6. Subject agrees to provide blood for Proclarix® and phi testing at the Screening Visit. Exclusion Criteria: \-

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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 detection

How to take part

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

  1. The places running it

    7 sites. 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

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Chesapeake Urology Associates

    RECRUITING

    Hanover, Maryland, 21076, United States

  • Chesapeake Urology Associates

    RECRUITING

    Towson, Maryland, 21204, United States

  • Crystal Run Healthcare

    RECRUITING

    Middletown, New York, 10941, United States

  • Graves Gilbert Clinic

    RECRUITING

    Bowling Green, Kentucky, 42101, United States

  • Idaho Urologic Institute

    RECRUITING

    Meridian, Idaho, 83642, United States

  • Om Research

    RECRUITING

    San Diego, California, 92123, United States

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