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
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.
Some Inclusions/Exclusions:
-Prior radical prostatectomy (>6 weeks prior to screening) or radiation therapy(>1 year prior to screening) with curative intent.
-Recurrence of disease defined as: (a) prior radical prostatectomy: PSA >.2 ng/ml followed by confirmatory PSA value >.2nl/ml OR (b) prior radiation therapy: 2ng/ml rise in PSA over post treatment nadir.
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