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New scan could spot hidden prostate cancer spread

NCT ID NCT07615101

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Updated 2 times

Summary

This phase 3 trial is testing a new radioactive imaging agent called 68Ga-NYM032, given as an injection before a PET/CT scan, in 365 men newly diagnosed with prostate cancer. The goal is to see if this scan can accurately detect whether the cancer has spread to pelvic lymph nodes, compared to standard tissue analysis after surgery. If it works, it could help doctors decide on the best treatment without needing invasive procedures.

What this could mean

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

Active substance
68Ga-NYM032 (a radioactive imaging agent injected intravenously for PET/CT scans)
What this could lead to
If successful, this could provide a more accurate, non-invasive way to detect whether prostate cancer has spread to nearby lymph nodes, helping guide treatment decisions.
What could go wrong
This is still an experimental imaging agent. It may not prove more accurate than current methods, and results from this single-arm study may not apply to all patients.

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 365 people

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

Started

Aug 2026

Expected to finish

Jul 2027

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. Biopsy proven prostate adenocarcinoma. 3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND). 4. ECOG performance status 0-2; expected survival ≥ 6 months. 6\. 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.

disease prostate adenocarcinoma prostate cancer

As listed by the trial registrant

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

Prostate cancer (diagnosis)

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

    RECRUITING

    Nanjing, Jiangsu, China

  • Affiliated Hospital of Jiangnan University

    RECRUITING

    Wuxi, Jiangsu, China

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