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

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

Timeline

Start

2024-11-21

Primary completion

2025-11

Completion

2025-11

Outcome

Met primary endpoint

paper Mean per-participant lesions were higher in 64Cu-bisPSMA (1.26) versus 68GaPSMA (0.48), difference 0.78 (95% CI: 0.52-1.04), ratio 2.63 (95% CI: 1.64-4.20) (p < 0.0001). PMID 41904043 ↗

Publications

• Khan S, Papa N, Kneebone A, Eade T, Ayati N, Nguyen A, Wong K, Chen J, Ho B, Idiare J, Sidhom G, Roberts MJ, Thompson J, Sharma S, Weir S, Devitt K, Kooner R, Lieng H, Rasiah K, Olphert J, de Leon J, Hruby G, Stricker P, Emmett L. Prospective Comparison of 64Copper [64Cu]SAR-bisPSMA vs 68Gallium[68Ga] PSMA-11 PET/CT for Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy (Co-PSMA Trial). Eur Urol. 2026 Jun;89(6):512-520. doi: 10.1016/j.eururo.2026.03.001. Epub 2026 Mar 28.

Drugs

Indications