🏛️ Verified NIH Record • Updated 2026-08-13

Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer (NCT06235151)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Curium US LLC

🩺 Plain-English Summary (8th-Grade Level)

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).

Location: Urology Centers of Alabama — Homewood, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (43 Sites)

  • Urology Centers of Alabama — Homewood, Alabama
  • Arkansas Urology — Little Rock, Arkansas
  • Providence Medical Foundation — Fullerton, California
  • Tower Urology — Los Angeles, California
  • VA Greater Los Angeles Healthcare System — Los Angeles, California
  • Hoag Memorial Hospital Presbyterian — Newport Beach, California
  • University of California, Irvine — Orange, California
  • San Francisco VA Medical Center — San Francisco, California
  • UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California
  • Providence Saint John's Health Center — Santa Monica, California
  • Stanford Hospital & Clinics — Stanford, California
  • Georgetown University Medical Center — Washington D.C., District of Columbia
  • University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center — Miami, Florida
  • CIRA Health — Miami, Florida
  • Sarasota Memorial Health Care System — Sarasota, Florida
  • Florida Urology Partners — Tampa, Florida
  • Edward Hines Jr. VA Hospital — Hines, Illinois
  • Urology of Indiana, LLC — Carmel, Indiana
  • IU Health Neuroscience Center — Indianapolis, Indiana
  • University of Iowa — Iowa City, Iowa
  • The University of Kansas Hospital — Kansas City, Kansas
  • United Theranostics — Glen Burnie, Maryland
  • VA Boston Healthcare System — Boston, Massachusetts
  • M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota
  • SSM Health Saint Louis University Hospital — St Louis, Missouri

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗