64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer

Study Overview
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Brief Summary
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This research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer.

Detailed Description
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This is a prospective, non-randomized, single arm, single center, open-label study of 64Cu-SAR-bisPSMA PET in patients with known or suspected prostate cancer (PC). Patients will be screened during a 28-day period and assessed against the inclusion and exclusion criteria. During screening the investigator will determine the patient's disease status (for patients with suspected prostate cancer) or stage of disease (for patients with known prostate cancer) and management plan based on the available standard of care test results (including available imaging, histopathology, biochemical markers, clinical and symptoms history, etc.). Eligible patients will receive a single administration of 64Cu-SAR-bisPSMA and complete a PET scan at an early time (1-4 hours) and a late time (24-72 hours). The patient's status will only be assessed in patients with suspected disease at study entry and will be characterized as suspected or known prostate cancer during the follow up. Staging will only be assessed in patients with known prostate cancer at study entry and will be characterized according to the TNM system and as Localized, Regional or Distant (nodes/visceral/bone).

Official Title
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64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer: A Prospective, Non-randomized, Single Arm, Single Center, Open-label Phase 1/2 Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: 64Cu-SAR-bisPSMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed an informed consent. >18 years of age. Known diagnosis of prostate adenocarcinoma confirmed by histopathology OR patients with suspicion of prostate cancer based on elevated PSA but negative standard of care imaging and/or negative biopsy. The Eastern Cooperative Oncology (ECOG) performance status 0-2. Adequate recovery from acute toxic effects of any prior therapy. Adequate renal function (eGFR of 30 ml/min/1.73m2 or higher) Exclusion Criteria: Participants must not receive other investigational agents within 28 days prior to 64Cu-SAR-bisPSMA administration. Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to 64Cu-SAR-bisPSMA administration. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, non-randomized, single arm, single center, open-label study .
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 64Cu-SAR-bisPSMA|Diagnostic PET/CT imaging agent targeted for Prostate Specific Membrane Antigen (PSMA)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety of 64Cu-SAR-bisPSMA (all patients). | To assess treatment emergent adverse events. | From injection of 64Cu-SAR-bisPSMA to one week following. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease status adjustment (patients with suspected disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging. | Disease status will be assessed before and after 64Cu-SAR-bisPSMA PET/CT Imaging. | Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging | 
| Disease Staging adjustment (for patients with known disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging. | Disease staging will be assessed before and after 64Cu-SAR-bisPSMA PET/CT Imaging | Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging | 
| Clinical Management plan before vs after 64Cu-SAR-bisPSMA PET/CT Imaging. | Clinical Management plan will be documented before and after 64Cu-SAR-bisPSMA PET/CT Imaging. | Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging |