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New scan could spot returning prostate cancer earlier

NCT ID NCT07649122

Diagnosis Sponsor: Norroy Bioscience Co., LTD 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 2 times

Summary

This study tests a new PET/CT imaging agent called 68Ga-NYM032 in 232 men with suspected prostate cancer recurrence after initial treatment. Participants have rising PSA levels, and the scan aims to accurately locate any remaining cancer. The goal is to see how well the scan detects cancer compared to standard methods, with a focus on safety and accuracy.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 232 people

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

Started

Aug 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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

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. Patient is male and aged \>18 years old. 2. Participants with histopathologically confirmed prostate adenocarcinoma, who present with elevated PSA and suspected recurrence following radical prostatectomy and/or radiotherapy and/or other radical prostate cancer treatments (e.g., proton therapy, cryoablation, high-intensity focused ultrasound, etc.). (PSA must be measured within 30 days prior to screening.). (Meeting any one of the following criteria): 1. Post-radical prostatectomy (RP): PSA ≥0.2 ng/mL on two consecutive measurements obtained ≥6 weeks after surgery; 2. Post-radiotherapy (as defined by the ASTRO-Phoenix consensus): PSA rise ≥2 ng/mL above the PSA nadir; 3. Participants with recurrence after other treatments: PSA rise ≥2 ng/mL above the PSA nadir. 3. ECOG performance status 0-2; expected survival ≥ 6 months. 4. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection. 2. Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection. 3. Known hypersensitivity to the active ingredient or excipients of the study drug. 4. Participants not capable of getting PET study , or inability to lay still for the duration of the exam. 5. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma 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

    2 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 Drum Tower Hospital, Medical School of Nanjing University

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, China

  • Affiliated Hospital of Jiangnan University

    RECRUITING

    Wuxi, Jiangsu, China

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