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
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.
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.
St Vincent's Hospital, Sydney
Lead sponsor
Clarity Pharmaceuticals Ltd
Collaborator