Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
NCT06235151 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 439
Last updated 2026-04-08
Summary
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.
Conditions
- Prostate Cancer
- Prostate Adenocarcinoma
Interventions
- DRUG
-
Copper Cu 64 PSMA I&T
Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.
Sponsors & Collaborators
-
Curium US LLC
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-01
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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