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

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

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

Inclusion Criteria:

• Male patients aged 18 or above
• Ability to provide informed consent documentation indicating that they understand the purpose of, and procedures required for the study, and are willing to participate in the study.
• Prior radical prostatectomy for confirmed adenocarcinoma on histopathology.
• Rising PSA (0.20 - 0.75 ng/mL) following radical prostatectomy with no prior salvage radiotherapy.
• 68Ga PSMA-11 PET/CT within the last 4 weeks for prostate cancer biochemical recurrence.

Exclusion Criteria:

• Prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer.
• History of current active malignancy as per investigator discretion other than prostate cancer.
• Known or expected hypersensitivity to 64Cu-SAR-bisPSMA
• Systemic therapy for metastatic prostate cancer including androgen deprivation therapy.