64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
• At least 18 years of age.
• Signed informed consent.
• Life expectancy ≥ 6 months as determined by the Investigator.
• Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
• Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2).
• PSA level after definitive therapy:
‣ Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or
⁃ Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition).
• Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
• An Eastern Cooperative Oncology performance status of 0-2.