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New scan could help doctors spot hidden prostate cancer spread

NCT ID NCT06235151

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Updated 1 time

Summary

This study tests a new type of PET/CT scan using a radioactive tracer called copper Cu 64 PSMA I&T to see if it can accurately find prostate cancer that has spread to pelvic lymph nodes. About 439 men with newly diagnosed, aggressive prostate cancer who are planning to have their prostate removed will get this scan before surgery. The results will be compared to the actual tissue removed during surgery to see how well the scan works.

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 439 people

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

Started

Apr 2024

Expected to finish

Sep 2026

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: * Patients with histologically proven prostate adenocarcinoma. * Planned prostatectomy with pelvic lymph node dissection. * Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions. * Male aged greater than or equal to 18 years. * Able to understand and provide signed written informed consent. Exclusion Criteria: * Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy. * 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 study) 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.

Prostate adenocarcinoma Prostate cancer

Contacts and locations

Locations

  • Adaptive Research Inc.

    Hawthorne, New York, 10532, United States

  • Arkansas Urology

    Little Rock, Arkansas, 72211, United States

  • CIRA Health

    Miami, Florida, 33165, United States

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dayton Physicians Network / Greater Dayton Cancer Center

    Kettering, Ohio, 45409, 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

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, 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

  • Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

  • IU 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

  • SSM Health Saint Louis University Hospital

    St Louis, Missouri, 63104, United States

  • San Francisco VA Medical Center

    San Francisco, California, 94121, United States

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34239, United States

  • Stanford Hospital & Clinics

    Stanford, California, 94305, United States

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • The Urology Place

    San Antonio, Texas, 78240, United States

  • Tower Urology

    Los Angeles, California, 90048, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158, United States

  • UNC Cancer Center

    Chapel Hill, North Carolina, 27514, United States

  • United Theranostics

    Glen Burnie, Maryland, 21061, United States

  • United Theranostics

    Princeton, New Jersey, 08540, United States

  • University of California, Irvine

    Orange, California, 92868, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • Urology Centers of Alabama

    Homewood, Alabama, 35209, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

  • Urology of Indiana, LLC

    Carmel, Indiana, 46032, United States

  • VA Boston Healthcare System

    Boston, Massachusetts, 02130, United States

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073, United States

  • VA Portland Health Care System

    Portland, Oregon, 97239, United States

  • XCancer

    Omaha, Nebraska, 68130, United States

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