This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.
This is an trial designed to evaluate the positive predictive value of 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing PSA levels. Patients will receive a single dose of 18FDCFPyL PET and undergo a PET imaging study. 18F-DCFPyL Injection is an 18F-labeled small molecule that targets the extracellular domain of PSMA. One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with ≤ 333 MBq (≤ 9 mCi) of 18F-DCFPyL via this catheter. The dose range for 18F-DCFPyL will be 7 - 9 mCi. The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
47
18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Positive Predictive Value (PPV) (Per-patient)
Number of patients with true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without disease). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake.
Time frame: Up to 12 months
Positive Predictive Value (PPV) (Per-region)
Number of true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without true disease), by region (prostate bed, locoregional lymph nodes, distant lymph nodes, bones, and/or visceral organs). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake.
Time frame: Up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.