64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)

Study Overview
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Brief Summary
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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.

Official Title
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64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 1/2 Study of Participants With Biochemical Recurrence of Prostate Cancer

Conditions
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Biochemical Recurrence of Malignant Neoplasm of Prostate

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. Life expectancy ≥ 12 weeks as determined by the Investigator. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy. Suspected recurrence of prostate cancer (PC) based on rising Prostate-specific antigen (PSA) after definitive therapy on the basis of: Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition). Negative or equivocal findings for PC on conventional imaging performed as part of standard of care workup within 60 days prior to Day 0. The Eastern Cooperative Oncology performance status 0-2. Adequate recovery from acute toxic effects of any prior therapy. Estimated Glomerular Filtration Rate of 30 mL/min or higher. Adequate liver function. For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection. Exclusion Criteria: Participants who received other investigational agents within 28 days prior to Day 0. Participants administered any high energy (>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day 0. Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy (e.g. androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist) for PC. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of 64Cu-SAR-bisPSMA Treatment-Emergent Adverse Events and Serious Adverse Events [Safety and Tolerability] | Adverse Events will be as assessed by CTCAE version 5.0 | 7 days | 
| Participant-level correct detection rate | Proportion of true positive participants on the Day 0 scan out of all participants with a Day 0 scan. | 1- 4 hours | 
| Participant-level correct detection rate | Proportion of true positive participants on the Day 1 scan out of all participants with a Day 1 scan. | 24 hours | 
| Region-level positive predictive value | Proportion of true positive regions on the Day 0 scan out of all positive regions on the Day 0 scan | 1- 4 hours | 
| Region-level positive predictive value | Proportion of true positive regions on the Day 1 scan out of all positive regions on the Day 1 scan | 24 hours |