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New imaging trick could spot dangerous prostate cancers earlier

NCT ID NCT07531329

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether taking a delayed PET/CT scan 2-3 hours after injection of a radioactive tracer can better detect aggressive prostate cancer compared to the standard 60-minute scan. Researchers will enroll 1,000 men with suspected prostate cancer who have not yet had a biopsy. Each man will act as his own control, and the goal is to see if the delayed scan improves accuracy and could help some men avoid unnecessary biopsies.

What this could mean

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

Active substance
PSMA PET/CT scan with a radioactive tracer (gallium-68 PSMA-11)
What this could lead to
If successful, this could lead to a more accurate imaging method to detect aggressive prostate cancer, potentially reducing unnecessary biopsies.
What could go wrong
This is a diagnostic study, not a treatment trial. The improvement from delayed imaging may be small, and results may not change clinical practice significantly.

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 2021

Expected to finish

Mar 2028

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 population consists of a consecutive series of patients with suspected prostate cancer based on elevated PSA levels (≥4.0 ng/mL) who are referred for initial diagnostic evaluation at participating centers. All enrolled patients undergo dual-phase \[⁶⁸Ga\]Ga-PSMA-11 PET/CT imaging (standard whole-body acquisition at approximately 60 minutes post-injection, followed by delayed pelvic PET acquisition at approximately 2-3 hours post-injection) prior to transrectal or transperineal prostate biopsy. Eligible patients must have no prior history of prostate cancer-related treatment and no other active malignancy within the past two years. This prospective cohort represents a typical diagnostic population in whom the incremental value of delayed PSMA PET imaging for prostate cancer detection is being investigated.

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 suspected prostate cancer and a PSA level ≥4.0 ng/mL 2. Patients who undergo PSMA PET imaging (including delayed phase imaging) prior to prostate biopsy 3. Patients who are willing to undergo prostate biopsy 4. Patients who provide written informed consent to participate in the study Exclusion Criteria: 1. Patients who have received any prior prostate cancer-related treatment before the initial PSMA PET scan 2. Patients with a history of other malignancies within the past two years 3. Patients judged by the study investigator to be at risk for serious complications that could interfere with the normal conduct of the study

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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.

Molecular imaging Suspected prostate cancer Treatment-naive 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

    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, Qinghai, 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 Hospita

    RECRUITING

    Weinan, Shaanxi, China

  • Xijing 986 Hospital

    RECRUITING

    Xi'an, Shaanxi, 710032, China

  • Xijing Hospital

    RECRUITING

    Xi'an, Shaanxi, 710032, China

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