The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
At least 18 years of age.
Signed informed consent.
Untreated, histologically confirmed adenocarcinoma of the prostate.
High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL).
Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
Patients with known predominant small cell or neuroendocrine PC.
Single group
64Cu-SAR-bisPSMA
DrugAll Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
Independent primary endpoints for Day 1 and Day 2 PET: Co-primary endpoint of sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer within the pelvic lymph nodes compared to the Standard of Truth.
Safety and tolerability of 64Cu-SAR-bisPSMA
Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA
Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers
Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic
PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs
PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth
Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer
Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth
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