Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

Study Overview
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Brief Summary
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The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.

Official Title
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Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study

Conditions
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Prostate Cancer, Prostatic Neoplasms

Intervention / Treatment
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* Drug: 64Cu-SAR-bisPSMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Patients electing to undergo RP with PLND. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 64Cu-SAR-bisPSMA<br>200MBq 64Cu-SAR-bisPSMA. | Drug: 64Cu-SAR-bisPSMA<br>* All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of 64Cu-SAR-bisPSMA | Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA | Up to 16 weeks | 
| 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 | Up to 16 weeks | 
| 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 | Up to 16 weeks | 
| 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 | Up to 16 weeks | 
| Ability of 64Cu-SAR-bisPSMA PET to detect primary Prostate Cancer | Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth | Up to 16 weeks | 
| Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching | Sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth, without the requirement of subregion (Left or Right) matching between 64Cu-SAR-bisPSMA PET and Standard of Truth | Up to 16 weeks |