Comparing 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PETCT Scans to Detect Prostate Cancer Return After Surgery A Study in Men with Rising PSA Levels Following Radical Prostatectomy

What this Trial Is About

Researchers are evaluating the performance of two imaging scans, 64Cu-SAR-bisPSMA PETCT and 68Ga PSMA-11 PETCT, in men who have rising prostate-specific antigen PSA levels after undergoing radical prostatectomy for prostate cancer. The study aims to determine differences in the number of cancer recurrence lesions detected, diagnostic accuracy compared to standard care, and how the new imaging might influence clinical management decisions. This is a phase 2 clinical trial sponsored by St Vincents Hospital, Sydney. Participants will receive a single dose of 200 MBq of 64Cu-SAR-bisPSMA during the study. They will undergo three visits the first includes the standard 68Ga PSMA-11 PETCT scan and dose, the second involves the 64Cu-SAR-bisPSMA dose and PETCT scan, and the third visit will have only the 64Cu-SAR-bisPSMA PETCT scan. A standard blood test will be done either at the first or second visit. During the study, researchers will assess the detection rate of lesions per participant, compare the number of lesions inside and outside the prostate area, and evaluate the diagnostic accuracy of the new scan compared to the standard. They will also study changes in clinical management based on the additional imaging and monitor PSA response after salvage radiotherapy. The total study duration for outcome measures is 12 months, with ongoing safety and effectiveness assessments throughout.

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