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
St Vincent's Hospital, Sydney
50 participants
Nov 21, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria5
- 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.
- Ga PSMA-11 PET/CT within the last 4 weeks for prostate cancer biochemical recurrence.
Exclusion Criteria4
- 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.
Interventions
All participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA
Locations(1)
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NCT06907641