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New scan could pinpoint returning prostate cancer

NCT ID NCT06235099

Diagnosis Sponsor: Curium US LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This Phase 3 study tested a radioactive tracer called Copper Cu 64 PSMA I&T, given as an injection, to improve PET/CT scans in 235 men with prostate cancer that may have returned after initial treatment (surgery or radiation). The goal was to see how accurately the scan could detect and locate cancer recurrence. If proven effective, this imaging method could help doctors decide on the best next steps for treatment.

What this could mean

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

Active substance
Copper Cu 64 PSMA I&T (a radioactive tracer injected into a vein for PET/CT imaging)
What this could lead to
If successful, this imaging method could help doctors more accurately locate where prostate cancer has returned, guiding better treatment decisions.
What could go wrong
This is a completed Phase 3 study, but the results are not yet published. The test may not be more accurate than existing scans, and false positives or negatives are possible.

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

235 people

The number who actually took part.

Started

Apr 2024

Finished

Feb 2025

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: * Patients with histologically proven prostate adenocarcinoma. * Prior radical prostatectomy (greater than 6 weeks prior to screening) or radiation therapy (greater than 1 year prior to screening) with curative intent. * Recurrence of disease defined as: 1. Prior radical prostatectomy: PSA greater than or equal to 0.2 ng/mL followed by subsequent confirmatory PSA value greater than or equal to 0.2 ng/mL or 2. Prior radiation therapy: 2 ng/mL rise in PSA over post-treatment nadir. * Male aged greater than or equal to 18 years. * Able to understand and provide signed written informed consent. Exclusion Criteria: * Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway within the past 3 months. Patients with a rising PSA level while on ADT for greater than 6 months are eligible. * Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration. * Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET scan) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements. * Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan. * Patients who are administered any high-energy (greater than 300 keV) gamma-emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\&T administration. * Patients with known hypersensitivity to the active substance or any of the excipients of the IP. * Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.

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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.

Biochemical recurrence of malignant neoplasm of prostate Prostate adenocarcinoma Prostate cancer

Contacts and locations

Locations

  • Biogenix Molecular, LLC

    Miami, Florida, 33165, United States

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Edward Hines Jr VA Hospital

    Hines, Illinois, 60141, United States

  • Excel Diagnostics and Nuclear Oncology Center

    Houston, Texas, 77042, United States

  • Florida Urology Partners

    Tampa, Florida, 33615, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Great Plains Health, Diagnostic Imaging

    North Platte, Nebraska, 69101, United States

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Indiana University Health Neuroscience Center

    Indianapolis, Indiana, 46202, United States

  • James J. Peters VA Medical Center

    The Bronx, New York, 10468, United States

  • John Cochran VA Medical Center

    St Louis, Missouri, 63106, United States

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • Providence Saint John's Health Center

    Santa Monica, California, 90404, United States

  • Queens Hospital Center

    Jamaica, New York, 11432, United States

  • SSM Health Saint Louis University Hospital

    St Louis, Missouri, 63104, United States

  • San Francisco VA Medical Center

    San Francisco, California, 94121, United States

  • Stanford Hospital & Clinics

    Stanford, California, 94305, United States

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • Tower Urology

    Los Angeles, California, 90048, United States

  • University of California, Irvine

    Orange, California, 92868, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

  • Urology of Indiana, LLC

    Carmel, Indiana, 46032, United States

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073, United States

  • VA Portland Health Care System

    Portland, Oregon, 97239, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • XCancer

    Omaha, Nebraska, 68130, United States

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