The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with prostate-specific membrane antigen (PSMA)-negative biochemical recurrence of prostate cancer following definitive therapy.
Participants with biochemical evidence of recurrence of prostate cancer (PC) were evaluated with 64Cu-SAR-BBN PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later (e.g., histopathology/biopsy, conventional imaging, prostate specific antigen \[PSA\] reduction post focal salvage therapy or radiotherapy with no concomitant androgen deprivation therapy). Three independent, central readers blinded to the participant number, the time of the PET/CT scan, and the results of the conventional methodologies, assessed the 64Cu-SAR-BBN PET/CT. Three separate independent readers assessed the results of the conventional methodologies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
53
64Cu-SAR-BBN
Tower Urology
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Biogenix Molecular
Miami, Florida, United States
Bamf Health, Inc
Grand Rapids, Michigan, United States
Safety and Tolerability
Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 7 days post injection
Participant-level Correct Detection Rate (CDR) - Day 0
The percentage of true positive (TP) participants on the Day 0 scan out of all participants with a Day 0 scan.
Time frame: Day 0 (1-4 hours) post injection
Participant-level CDR - Day 1.
The percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan.
Time frame: Day 1 (24+/-6 Hours) post injection
Region-level Positive Predictive Value (PPV) - Day 0.
The percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan.
Time frame: Day 0 (1-4 hours) post injection
Region-level PPV - Day 1.
The percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan.
Time frame: Day 1 (24 +/- 6 hours) post injection
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 0
The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue, bone.
Time frame: Day 0 (1-4 hours) post injection
Biodistribution of 64Cu-SAR-BBN - SUVmean - Day 1
The SUVmean in lesions, visceral soft tissue, bone.
Time frame: Day 1 (24 +/- 6 hours) post injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St Louis University Hospital
St Louis, Missouri, United States
GU Research Network
Omaha, Nebraska, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology San Antonio
San Antonio, Texas, United States
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 0
The max Standardized Uptake Value (SUVmax) in lesions, visceral soft tissue and bone.
Time frame: Day 0 (1-4 hours) post injection
Biodistribution of 64Cu-SAR-BBN - SUVmax - Day 1
The SUVmax in lesions, visceral soft tissue and bone.
Time frame: Day 1 (24 +/- 6 hours) post injection
Biodistribution of 64Cu-SAR-BBN - SUVr - Day 0
Standardized Uptake Value Lesion to Background ratio (SUVr): SUVmax of the lesion divided by the SUVmean of gluteus background.
Time frame: Day 0 (1-4 hours) post injection
Biodistribution of 64Cu-SAR-BBN - SUVr - Day 1
SUVr: SUVmax of the lesion divided by the SUVmean of gluteus background.
Time frame: Day 1 (24 +/- 6 hours) post injection
Participant-level PPV
Percentage of TP participants out of all positive participants, derived separately for each timepoint and reader.
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection
Participant-level Detection Rate (DR)
Percentage of participants with a positive 64Cu-SAR-BBN PET/CT scan out of all participants with a 64Cu-SAR-BBN PET/CT scan for each timepoint and reader.
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection
Participant-level False Positive Rate (FPR)
Percentage of false positive (FP) participants out of all participants with a positive scan, derived separately for each timepoint and reader.
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection
Region-level FPR
Percentage of FP regions on the Day 0 or Day 1 scan out of all positive regions, derived separately for each timepoint and reader.
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection
Participant-level Discrepant PET Negativity Rate
Percentage of participants with contradicting Day 0 and Day 1 results for whom the Reference Standard was positive.
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection
Participant-level True Negative Rate (TNR)
Percentage of true negative (TN) participants on the Day 0 or Day 1 scan out of all participants with a negative Day 0 or Day 1 scan.
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours) post injection
Region-level TNR
Percentage of TN regions on the Day 0 or Day 1 scan out of all negative regions on the Day 0 or Day 1 scan.
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours) post injection