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Could a simple blood test replace biopsies for prostate cancer?

NCT ID NCT06604130

Diagnosis Sponsor: Xijing Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study is testing a new blood test that looks at RNA from tiny particles called exosomes to diagnose prostate cancer. Researchers will enroll 1,600 men with elevated PSA levels or other signs of prostate cancer. The goal is to see if this test can accurately detect cancer and reduce the need for 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
Plasma exosome RNA panel (diagnostic test)
What this could lead to
If successful, this could provide a more accurate, non-invasive blood test for prostate cancer, reducing unnecessary biopsies.
What could go wrong
This is an early diagnostic study, not a treatment trial. The test may not prove more accurate than existing methods, and results may not apply to all populations.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,600 people

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

Started

Mar 2021

Expected to finish

Dec 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.

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: 1. Blood prostate-specific antigen PSA\>4ng/dl; 2. Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging, and PSMA PET/CT examination. 3. The patient is willing to undergo prostate biopsy. Exclusion Criteria: 1. Previous diagnosis of prostate cancer through prostate biopsy; 2. History of other malignant tumors in the past two years; 3. According to the research physician\'s judgment, serious complications may occur and affect the normal conduct of the experiment

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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.

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

    9 sites. 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

  • Affiliated Hospital of Yan'an University,

    Yan’an, Shaanxi, 716000, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750000, China

  • Qinghai University Affiliated Hospital

    Xining, Qinghai, 810000, China

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710000, China

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000, China

  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    Xianyang, Shaanxi, 712000, China

  • Weinan Central Hospital

    Weinan, Shaanxi, 714000, China

  • Xijing 986 Hospital

    Xi'an, Shaanxi, 710000, China

  • Xijing Hospital

    Xi'an, Shaanxi, 710032, China

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