Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer
Trial ID or NCT#
NCT06235099
Status
NOT RECRUITING
Purpose
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 recurrent prostate cancer after radical prostatectomy or radiation therapy.
Official Title
A Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Men With Biochemical Recurrence of Prostate Cancer
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
- * Patients with histologically proven prostate adenocarcinoma.* Prior radical prostatectomy (greater than 6 weeks prior to screening) or radiation therapy (greater than 1 year prior to screening) with curative intent.* Recurrence of disease defined as:
- 1. Prior radical prostatectomy: PSA greater than or equal to 0.2 ng/mL followed by subsequent confirmatory PSA value greater than or equal to 0.2 ng/mL or 2. Prior radiation therapy: 2 ng/mL rise in PSA over post-treatment nadir.* Male aged greater than or equal to 18 years.* Able to understand and provide signed written informed consent.
Exclusion Criteria:
- * Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway within the past 3 months. Patients with a rising PSA level while on ADT for greater than 6 months are eligible.* Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.* Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET scan) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.* Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan.* Patients who are administered any high-energy (greater than 300 keV) gamma-emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\&T administration.* Patients with known hypersensitivity to the active substance or any of the excipients of the IP.* Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.
Investigator(s)
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Contact
Mikayla Easterling
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