The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.
This is a multi-centre, blinded review, dose ranging, non-randomized study of 64Cu-SAR-bisPSMA administered to participants with confirmed Prostate Cancer. 30 eligible participants will be allocated (1:1:3) to 1 of 3 dosing cohorts to be administered with 64Cu-SAR-bisPSMA 100 MBq, 150 MBq or 200 MBq. PET/CT scan images will be sent to blinded central readers to assess the capacity of 64Cu-SAR-bisPSMA to detect primary Prostate Cancer, to assess image quality of the various dose cohorts, and to assess the PET/CT scan features of 64Cu-SAR-bisPSMA in comparison standard of care.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
64Cu-SAR-bisPSMA
Nepean Hospital
Kingswood, New South Wales, Australia
St. Vincent's Hospital
Sydney, New South Wales, Australia
GenesisCare CTA, SJOG Medical Clinic
Murdoch, Western Australia, Australia
Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5
Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.
Time frame: 11 weeks
Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology
Efficacy will be measured by the proportion of 64Cu-SAR-bisPSMA PET/CT scans assessed as True Positive or False Negative for primary Prostate Cancer, as confirmed by histopathology.
Time frame: 11 weeks
Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq).
Image quality will be assessed by 2 blinded central readers.
Time frame: 11 weeks
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