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Prostate cancer blood test targets particles shed by tumors

NCT ID NCT03694483

Diagnosis Sponsor: Hackensack Meridian Health 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are studying whether a blood test can detect prostate cancer by finding prostasomes, tiny particles that prostate cancer cells release into the blood. The trial enrolls men with elevated PSA levels or diagnosed prostate cancer who have not yet received treatment. The study has two parts: first, checking how well the test identifies prostasomes in blood samples, and second, analyzing the genetic material inside those particles to see if it can reveal how aggressive the cancer is. The goal is to develop a liquid biopsy that could replace or reduce the need for tissue biopsies.

What this could mean

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

Active substance
a blood test that detects and purifies prostasomes, tiny particles shed by prostate cancer cells
What this could lead to
If it works, this could offer a simple blood test for prostate cancer that avoids the need for a tissue biopsy and gives doctors information about how aggressive the tumor is.
What could go wrong
The test is still being validated and may not prove reliable enough for routine use. It also requires specialized lab processing that may be hard to standardize across hospitals.

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 600 people

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

Started

Oct 2018

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

All male patients with elevated PSA and suspected for prostate cancer or patients with diagnosed prostate cancer but prior to treatment will be invited to participate. Depending on the results from the diagnostic MRI-guided biopsy, participants will be assigned to either the control cohort (if biopsy is negative) or the patient cohort (if biopsy is positive).

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Male * With elevated PSA or patients with diagnosed prostate cancer * 18 years and older * Willingness to participate in the study and compliance with protocol requirements * Have not received any type of treatment for prostate cancer Exclusion Criteria: * Patients with confirmed or suspected prostate cancer that have already received any type of treatment * Patients with another primary cancer within the past five years of prostate cancer diagnosis. However, superficial skin cancers such as basal cell or squamous cell cancers would not exclude a patient.

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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

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

    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

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

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