Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA

Study Overview
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Brief Summary
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This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography (PET) works in detecting prostate cancer in patients with persistently elevated prostate specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a compound made of a radioactive agent attached to a molecule that looks like a hormone that binds to cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET may be able to see tumors at an earlier stage than the standard of care.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect prostate cancer (PC), or absence thereof, within the prostate gland.

Official Title
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A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men With Persistently Elevated PSA

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Copper Cu 64 TP3805
* Procedure: Positron Emission Tomography and Computed Tomography Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide signed informed consent and willingness to comply with protocol requirements Persistently elevated PSA Scheduled for magnetic resonance imaging (MRI) fusion/transrectal ultrasound (TRUS) biopsy, followed by histology Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection Exclusion Criteria: Participating would significantly delay the scheduled standard of care therapy Administered a radioisotope within 10 physical half-lives prior to study drug injection Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study

Ages Eligible for Study
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Minimum Age: 21 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: Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)<br>Patients receive copper Cu 64 TP3805 IV over 5 minutes and 30 minutes and 2 hours later, undergo whole body Positron Emission Tomography/Computed Tomography (PET/CT) imaging over 1 hour. | Radiation: Copper Cu 64 TP3805<br>* Given Intravenously<br>* Other names: Cu-64-TP3805;Procedure: Positron Emission Tomography and Computed Tomography Scan<br>* Undergo copper Cu 64 TP3805 PET/CT scan<br>* Other names: Positron Emission Tomography/Computed Tomography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate cancer detection within the prostate gland by copper Cu 64 TP3805 PET | The proportion of lesions detected with copper Cu-64 PET will be determined with the lesion as the unit of analysis. 95% confidence intervals will be calculated. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of multiple lesions in an individual patient | Generalized Estimating Equations will be utilized. | Up to 3 years |