64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer

Must have received: definitive therapy — completed

completed subsequent definitive therapy

Cannot have received: investigational agent

Participants who received investigational agent within 5 biological half-lives prior to Day 1

Cannot have received: high energy (>300 KeV) gamma-emitting radioisotope

Participants administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1

Cannot have received: systemic therapy for prostate cancer

Exception: neoadjuvant and adjuvant systemic therapy as part of the definitive therapy and/or salvage therapy with radiation

Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy and/or salvage therapy with radiation)

Cannot have received: ongoing or recent systemic therapy (within 6 months) for prostate cancer (investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy, radiotherapy)

Ongoing treatment or treatment within 6 months of Day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for PC