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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-048 | Other Identifier | Thomas Jefferson University | |
| NCI-2015-01533 | Registry Identifier | NCI Clinical Trials Reporting Program | |
| JT 2479 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (Cu 64 TP3805 PET/CT) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copper Cu 64 TP3805 | Radiation | Given IV |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhukar Thakur, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center | View source |
| Thomas Jefferson University Hospital | View source |
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| Positron Emission Tomography | Procedure | Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT |
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| Computed Tomography | Procedure | Undergo Cu-64-TP3805 PET/CT (Computed Tomography) |
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| Radical Prostatectomy | Procedure | Undergo radical prostatectomy |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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