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Simple blood test could spare prostate cancer patients from unnecessary scans

NCT ID NCT07553754

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to develop a blood test that detects RNA from tiny particles (exosomes) to predict if prostate cancer has spread to the bones. Researchers will analyze blood samples from 1,000 men with newly diagnosed prostate cancer and compare results with PSMA PET scans. The goal is to create a test that can reliably rule out bone metastasis, potentially reducing the need for expensive imaging in low-risk patients.

What this could mean

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

Active substance
Plasma exosomal RNA signature (liquid biopsy test)
What this could lead to
If successful, this blood test could safely rule out bone metastasis in low-risk prostate cancer patients, avoiding unnecessary PSMA PET scans and reducing healthcare costs.
What could go wrong
This is an early-phase diagnostic study with a target specificity of only 30%, meaning many patients may still need imaging. The test is not yet validated for routine clinical use.

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 1,000 people

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

Started

Mar 2026

Expected to finish

Dec 2027

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

The study enrolls a total of approximately 1000 patients with histologically confirmed prostate cancer from multiple centers. All patients undergo baseline PSMA PET/CT and provide pre-treatment blood samples (collected before any therapy and before prostate biopsy). The single overall cohort is allocated into four sequential, independent phases: Phase 1 (Discovery, n=250), Phase 2 (Model Development, n≥300, bone-metastasis enriched), Phase 3 (Internal Validation, n≥300, natural prevalence), and Phase 4 (External Validation, n=150, multi-center enriched). Bone metastasis status is defined by PSMA PET/CT.

Ages

18 years and older

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. Patients with histologically confirmed prostate cancer who are scheduled to undergo baseline PSMA PET imaging. 2. Patients who undergo PSMA PET imaging prior to any prostate cancer-related treatment (including androgen deprivation therapy, radiotherapy, or surgery). 3. Patients who provide blood samples for plasma exosomal RNA analysis collected prior to any treatment AND prior to prostate biopsy (if applicable). Whole blood samples (approximately 10 mL) will be collected in EDTA tubes at this specified time point. Samples will be processed within 2 hours to obtain plasma and stored at -80°C until analysis.This timing ensures circulating exosomal RNA profiles reflect tumor biology without biopsy-induced contamination. 4. Patients who are willing to undergo prostate biopsy if clinically indicated (biopsy performed after blood collection). 5. Patients who provide written informed consent to participate in the study. 6. Age ≥18 years. Exclusion Criteria 1. Patients who have received any prior prostate cancer-related treatment before the baseline PSMA PET scan (including hormonal therapy, radiotherapy, chemotherapy, or surgery). 2. Patients whose blood samples were collected after prostate biopsy. 3. Patients with a history of other active malignancies within the past two years (excluding non-melanoma skin cancer). 4. Patients with inadequate blood sample quality or quantity for exosomal RNA extraction and analysis (e.g., hemolysis, insufficient volume \<8 mL). 5. Patients with severe comorbidities or conditions that, in the judgment of the investigator, could interfere with study compliance or pose significant risk.

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Conditions

The condition(s) this trial relates to.

disease metastatic carcinoma in the bone prostate cancer

As listed by the trial registrant

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

Biomarker discovery and validation Bone metastasis Exosomal rna Liquid biopsy Prostate cancer (diagnosis) PSMA pet Treament-naive

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

    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

  • Affiliated Hospital of Yan'an University

    RECRUITING

    Yan’an, Shaanxi, China

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, Ningxia, China

  • Qinghai University Affiliated Hospital

    RECRUITING

    Xining, Shaanxi, China

  • Shaanxi Provincial People's Hospital

    RECRUITING

    Xi'an, Shaanxi, China

  • The First Hospital of Lanzhou University

    RECRUITING

    Lanzhou, Gansu, China

  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    RECRUITING

    Xianyang, Shaanxi, China

  • Weinan Central Hospital

    RECRUITING

    Weinan, Shaanxi, China

  • Xijing 986 Hospital

    RECRUITING

    Xi'an, Shaanxi, China

  • Xijing Hospital

    RECRUITING

    Xi'an, Shaanxi, 710032, China

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