Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Recruiting
Phase 3
Interventional Study
Prostate Cancer
Prostate Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 439 (estimated)
- Sponsor
- Curium US LLC · Industry
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About This Trial
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.
Trial Locations
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Eligibility 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 th…
Contacts