Clinical Trial

Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy

Study acronym: Co-PSMA
Completed Phase 2
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are: * Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans. * What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET/CT compared to 68Ga PSMA-11 PET/CT using a standard of care comparator. * Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11). Participants will: * have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET/CT scan; 2) 64Cu-SAR-bisPSMA dose and PET/CT; 3) 64Cu-SAR-bisPSMA PET/CT only * have standard of care blood test either at Visit 1 or Visit 2
Protocol Amendment History 3 changes
critical Trial completed 2026-08-15
notable Primary completion moved earlier: 2025-11 -> 2025-09-03 2026-08-15
minor Completion moved earlier: 2025-11 -> 2025-09-03 2026-08-15
Trial Details
NCT Number NCT06907641
Lead Sponsor St Vincent's Hospital, Sydney
Collaborators: Clarity Pharmaceuticals Ltd
Conditions Prostate Cancer (Post Prostatectomy)
Enrollment 50 participants
Start Date 2024-11-21
Primary Completion 2025-09-03 (estimated)
Study Completion 2025-09-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-14