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New PET tracer could sharpen prostate cancer detection

NCT ID NCT07689656

Diagnosis Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study tests a new radioactive imaging agent called [68Ga]Ga-ELI421 for PET scans in people with prostate cancer. The goal is to see if it is safe and can accurately highlight cancer cells in the body. Researchers will also measure how the agent spreads and how much radiation it delivers. The trial involves 50 adults with confirmed prostate cancer who need a PSMA PET scan.

What this could mean

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

Active substance
[68Ga]Ga-ELI421 injection (a radioactive imaging agent)
What this could lead to
If successful, this could provide a more precise way to detect and monitor prostate cancer using PET scans, potentially improving diagnosis and treatment planning.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 50 participants, so the imaging agent may not prove safe or effective in larger, more diverse groups. There is also a small risk of radiation exposure from the radioactive tracer.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 50 people

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

Started

Jun 2026

Expected to finish

Dec 2026

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.

Ages

18 to 80 years

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. Has been fully informed about the study and voluntarily provided written informed consent prior to initiation of any study-related procedures; 2. Aged ≥ 18 years; 3. In generally good condition with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 4. Patients with histopathologically and/or cytologically confirmed prostate cancer; 5. Has an indication for PSMA PET imaging; 6. No clinically significant abnormal findings on physical examination, vital signs, laboratory tests, 12-lead ECG, or other examinations that may compromise subject safety or imaging results. 7. Subjects of reproductive potential agree to refrain from pregnancy, sperm donation, and voluntarily use highly effective contraceptive methods (including by their partner) for 6 months after study drug administration, such as condoms, oral or injectable contraceptives, intrauterine devices (IUDs), etc. Exclusion Criteria: 1. Presence of comorbidities that may compromise subject safety or interfere with imaging results; 2. Concomitant medications that may compromise subject safety or interfere with imaging results; 3. Insufficient washout period following prior anti-tumor therapies (including cytotoxic chemotherapy, immunotherapy, radiotherapy, etc.), which may compromise subject safety or interfere with imaging results; 4. Known hypersensitivity to ionizing radiation or alcohol, or hypersensitivity to \[⁶⁸Ga\]Ga-ELI421 injection or its excipients, or other history of severe allergic reactions; 5. Inability to complete PET imaging as required; 6. Any other conditions deemed inappropriate by the investigator for participation in this study.

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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.

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

    1 site. 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

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430000, China

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