Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery

Study Overview
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Brief Summary
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This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate cancer undergoing surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). Many patients with benign lesions must undergo biopsy to test the lesion. Cu-64-TP3805 is a radioactive substance that attaches to cancer cells but not normal cells. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body where the radioactive substance is lighting up. Using Cu-64-TP3805 PET/CT scans and comparing them with cancer tissue obtained from surgery may help doctors learn whether Cu-64-TP3805 PET/CT can accurately detect prostate lesions and determine whether they are cancerous or benign, which may minimize the need for prostate biopsies.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the ability of Cu-64-TP3805 to detect prostate cancer (PC) within the prostate gland, as compared with whole mount step-sectioned surgical pathology of the prostate after radical prostatectomy. OUTLINE: Patients receive copper Cu 64 TP3805 intravenously (IV) and undergo PET/computed tomography (CT) at 30 minutes and 2 hours post-injection. Patients then undergo radical prostatectomy within 1 to 3 weeks after scans. After completion of study, patients are followed up at 24 hours.

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 Undergoing Radical Prostatectomy

Conditions
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Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer

Intervention / Treatment
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* Radiation: Copper Cu 64 TP3805
* Procedure: Positron Emission Tomography
* Procedure: Computed Tomography
* Procedure: Radical Prostatectomy
* Other: Laboratory Biomarker Analysis


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 Biopsy confirmed presence of adenocarcinoma of the prostate gland Have intermediate or high-risk PC as defined by >= T2b disease, or Gleason score >= 7 or prostate-specific antigen (PSA) >= 10 ng/dL Scheduled to undergo radical prostatectomy with pelvic lymph node dissection (either open or robotic) 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 (Cu 64 TP3805 PET/CT)<br>Patients receive copper Cu 64 TP3805 IV and undergo PET/CT at 30 minutes and 2 hours post-injection. Patients then undergo radical prostatectomy within 1 to 3 weeks after scans. | Radiation: Copper Cu 64 TP3805<br>* Given IV<br>* Other names: Cu-64-TP3805;Procedure: Positron Emission Tomography<br>* Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;Procedure: Computed Tomography<br>* Undergo Cu-64-TP3805 PET/CT (Computed Tomography)<br>* Other names: CT SCAN;Procedure: Radical Prostatectomy<br>* Undergo radical prostatectomy<br>* Other names: Prostatovesiculectomy;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of Cu-64 PET imaging of PC | The proportion of lesions detected with Cu-64 PET will be determined and compared with tumor maps derived from the whole mount step sectioned surgical pathology analysis of the radical prostatectomy specimen after surgery. 95% confidence intervals will be calculated. As a secondary analysis, a generalized estimating equations will be utilized to account for multiple lesions in an individual patient. | Baseline (at time of surgery) | 
| Incidence of adverse events |  | Up to 30 days post Cu-64-TP3805 injection procedure |