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.
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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

Hassan El Gazri

+33 7 69 28 53 40

SOLAR@curiumpharma.com

CONTACT