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New scan could revolutionize prostate cancer monitoring

NCT ID NCT07553780

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a special type of scan called PSMA PET can better monitor how prostate cancer responds to treatment. Researchers will scan 110 men with high-risk prostate cancer before and after treatment to see if changes in the scan match standard measures like PSA levels. The goal is to find a more accurate way to guide treatment decisions.

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 imaging
What this could lead to
If successful, this could provide a more accurate way to monitor treatment response in prostate cancer, potentially guiding better treatment decisions.
What could go wrong
This is an observational study, not a treatment trial. It may not show clear benefits, and results might not change current practices.

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 110 people

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

Started

Mar 2021

Expected to finish

Dec 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

A consecutive series of approximately 110 patients (targeting 100 evaluable after 10% loss to follow-up) with newly diagnosed, histologically confirmed clinically significant prostate cancer (Gleason score ≥7), treatment-naïve, recruited from multiple centers. All patients undergo baseline PSMA PET/CT prior to any treatment. A second PSMA PET/CT is performed either at PSA recurrence (defined as PSA ≥0.2 ng/mL after radical prostatectomy or PSA rise ≥2 ng/mL above nadir after radiotherapy) or at 12-24 months after treatment completion for those without biochemical recurrence. Patients receive standard clinical treatments per physician discretion. This single cohort is used to evaluate serial PSMA PET for treatment response monitoring.

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. Newly diagnosed, histologically confirmed prostate cancer with Gleason score ≥7 (clinically significant prostate cancer). 2. Planned to receive curative-intent therapy (radical prostatectomy or radiotherapy) or systemic therapy (androgen deprivation therapy, chemotherapy, or combination). 3. Undergo baseline PSMA PET/CT imaging prior to any prostate cancer-related treatment. 4. Age ≥18 years. 5. Willing and able to comply with the follow-up schedule, including the second PSMA PET/CT scan. 6. Provide written informed consent. Exclusion Criteria 1. Any prior prostate cancer treatment (including hormonal therapy, radiotherapy, chemotherapy, or surgery) before baseline PSMA PET/CT. 2. Contraindications to PSMA PET/CT imaging (e.g., known severe allergic reaction to radiotracer components, inability to lie flat for the duration of the scan). 3. Other active malignancy within the past two years, excluding non-melanoma skin cancer. 4. Severe comorbidities or conditions that, in the opinion of the investigator, could interfere with study compliance or pose a significant risk to the patient. 5. Unable or unwilling to provide informed consent.

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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.

High-risk prostate cancer PSMA pet Therapy monitoring Treatment response

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 Hospital

    RECRUITING

    Weinan, Shaanxi, China

  • Xijing 986 Hospital

    RECRUITING

    Xi'an, Shaanxi, China

  • Xijing Hospital

    RECRUITING

    Xi'an, Shaanxi, China

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