Brief 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 prostatectomycomplete or partial removal of the prostate gland. The main questions it aims to answer are:
- Is there a difference in the number of lesions of prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs recurrenceto occur or happen again 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 imagingtests that create detailed images of areas inside the body (68Ga PSMA-11).
Participants will:
- have 3 visits: 1) standard of care 68Ga PSMA-11 dosethe amount of medication taken and PET/CT scan; 2) 64Cu-SAR-bisPSMA dose and PET/CT; 3) 64Cu-SAR-bisPSMA PET/CT only
- have standard of care bloodthe red bodily fluid that transports oxygen and other nutrients around the body test either at Visit 1 or Visit 2
Intervention / Treatment
- Drug: 64Cu-SAR-bisPSMA
Inclusion Criteria:
- Male patients aged 18 or above
- Ability to provide informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. 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 adenocarcinomacancer arising from mucus-producing glands in organs 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.