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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA157372 | U.S. NIH Grant/Contract | View source | |
| JT 7709 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copper Cu 64 TP3805 | Radiation | Given Intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET | The proportion of participants with lesions detected with copper Cu-64 PET will be determined with the lesion as the unit of analysis. 95% confidence intervals will be calculated. | At 3 weeks post imaging visit |
| Measure | Description | Time Frame |
|---|---|---|
| Total Incidence of Multiple Lesions in an Individual Patient | Generalized Estimating Equations will be utilized to provide a total number of lesions | At 3 weeks post imaging procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhukar Thakur, PhD | 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 | View source |
| Thomas Jefferson University Hospital | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy) | 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. Copper Cu 64 TP3805: Given Intravenously Positron Emission Tomography and Computed Tomography Scan: Undergo copper Cu 64 TP3805 PET/CT scan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2019 |
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| Positron Emission Tomography and Computed Tomography Scan | Procedure | Undergo copper Cu 64 TP3805 PET/CT scan |
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|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy) | 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. Copper Cu 64 TP3805: Given Intravenously Positron Emission Tomography and Computed Tomography Scan: Undergo copper Cu 64 TP3805 PET/CT scan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET | The proportion of participants with lesions detected with copper Cu-64 PET will be determined with the lesion as the unit of analysis. 95% confidence intervals will be calculated. | Posted | Count of Participants | Participants | At 3 weeks post imaging visit |
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| |||||||||||||||||||||||||||
| Secondary | Total Incidence of Multiple Lesions in an Individual Patient | Generalized Estimating Equations will be utilized to provide a total number of lesions | Posted | Number | lesions | At 3 weeks post imaging procedure |
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subjects were monitored for 24 hours post imaging for adverse events
all adverse events were related to standard of care
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy) | 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. Copper Cu 64 TP3805: Given Intravenously Positron Emission Tomography and Computed Tomography Scan: Undergo copper Cu 64 TP3805 PET/CT scan | 0 | 25 | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mathew Thakur | Thomas Jefferson University | 215-503-7874 | Mathew.Thakur@Jefferson.edu |
| Jul 10, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 2, 2017 | Aug 3, 2023 | ICF_001.pdf |
| 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 |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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