Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer

Completed · Phase 2

Conditions studied: Metastasis From Malignant Tumor of Prostate (Disorder)

In brief

This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.

Key facts

Study ID

NCT05653856

Run by

Curium US LLC

People needed

26

Starts

2022-12-05

Expected to finish

2023-05-17

Last updated by the study team

2025-01-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically proven prostate adenocarcinoma.
• Prior radical prostatectomy or radiation therapy with curative intent.
• Recurrence of disease defined as:
• Prior Radical Prostatectomy: PSA > 0.2 ng/mL, or
• Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir
• Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
• Age greater than or equal to 18 years.
• Able to understand and provide signed written informed consent.

You may not qualify if…

• Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level.
• Body weight greater than 350 lb (158 kg).
• Investigational therapy within the past 30 days.
• Creatinine clearance (ClCr) less than 30 mL/min.
• Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.

Where it is running

• Yale University — New Haven, Connecticut, United States
• Edward Hines, Jr. VA Hospital — Hines, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Saint Louis University — St Louis, Missouri, United States
• John J. Cochran Veterans Hospital — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• XCancer Omaha/Urology Cancer Center — Omaha, Nebraska, United States
• MD Anderson — Houston, Texas, United States

Full record on ClinicalTrials.gov

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