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
Curium US LLC
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.
Description
The study will include approximately 439 patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer electing to undergo radical prostatectomy with pelvic lymph node dissection. Each patient will be administered an 8 mCi (± 10 percent) intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT imaging will be acquired for all patients at 1-4 hours ± 15 minutes post copper Cu 64 PSMA I\&T injection. The PET/CT images will be interpreted independently by three readers blinded to all patient information. Each patient study will be assessed and…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 pro…
Interventions
- DrugCopper Cu 64 PSMA I&T
Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.
Locations (43)
- Arkansas UrologyLittle Rock, Arkansas
- Providence Medical FoundationFullerton, California
- Tower UrologyLos Angeles, California
- VA Greater Los Angeles Healthcare SystemLos Angeles, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- University of California, IrvineOrange, California