The aim of this study is to determine the safety and efficacy of 64Cu-SAR-bisPSMA and determine the ability of 64Cu-SAR-bisPSMA Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following definitive therapy.
Participants with biochemical evidence of recurrence of PC were evaluated with 64CU-SAR-bisPSMA PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later, eg. Histopathology/biopsy, conventional imaging, 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-bisPSMA PET/CT. Three separate independent readers assessed the results of the conventional methodologies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
52
64Cu-SAR-bisPSMA
Tower Urology
Los Angeles, California, United States
GU Research Network
Omaha, Nebraska, United States
New Mexico Cancer Center
Albuquerque, New Mexico, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Safety and Tolerability
Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by CTCAE version 5.0
Time frame: up to 7 days post injection
Participant-level Correct Detection Rate (CDR)- Day 0
The percentage of 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)
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)
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue and bone.
Time frame: Day 0 (1 -4 hours) and Day 1 (24 +/- 6 hours) post injection
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
SUVmax in lesions, visceral soft tissue and bone
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Urology San Antonio
San Antonio, Texas, United States
Biodistribution of 64Cu-SAR-bisPSMA- SUVr
Lesion to Background ratio. SUVmax of the lesion divided by the SUVmean of gluteus background
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level PPV
Percentage of TP participants on the Day 0 or Day 1 scan out of all participants with a positive Day 0 or Day 1 scan.
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level Detection Rate (DR)
Percentage of participants with a positive Day 0 or Day 1 scan out of all participants with a Day 0 or Day 1 scan.
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level False Positive Rate (FPR)
Percentage of false positive (FP) participants on the Day 0 or Day 1 scan out of all participants with a positive Day 0 or Day 1 scan.
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Region-level FPR
Percentage of FP regions on the Day 0 or Day 1 scan out of all positive regions on the Day 0 or Day 1 scan.
Time frame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
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)
Participant-level True Negative Rate (TNR)
Percentage of 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)
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)