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Copper Cu 64 PSMA PET imaging for newly diagnosed prostate cancer

Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection

PHASE3 · Curium US LLC · NCT06235151

This study is testing a new imaging method using a copper injection to see if it can help find prostate cancer in men who have just been diagnosed with high-risk forms of the disease.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment439 (estimated)
Ages18 Years and up
SexMale
SponsorCurium US LLC (industry)
Drugs / interventionschemotherapy, radiation
Locations43 sites (Little Rock, Arkansas and 42 other locations)
Trial IDNCT06235151 on ClinicalTrials.gov

What this trial studies

This Phase 3 study evaluates the effectiveness of copper Cu 64 PSMA I&T injection for PET/CT imaging in men with newly diagnosed unfavorable intermediate high-risk, high-risk, or very high-risk prostate cancer. Approximately 323 patients will receive an intravenous dose of the injection before undergoing PET/CT imaging to detect prostate cancer lesions. The imaging results will be interpreted by three independent readers who are blinded to patient information, and the findings will be compared to histopathology results to determine the accuracy of the imaging technique.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with histologically proven prostate adenocarcinoma who are planning to undergo prostatectomy with pelvic lymph node dissection.

Not a fit: Patients who have received prior androgen deprivation therapy, chemotherapy, or radiation therapy for prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of prostate cancer staging and treatment planning for patients.

How similar studies have performed: Other studies have shown promising results with similar imaging approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Little Rock, Arkansas and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Prostate Cancer, Prostate Adenocarcinoma, PSMA, Initial Staging, Solar-Stage, Cu-64 PSMA, PET, Solar

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.