Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Copper Cu 64 TP3805
Positron Emission Tomography and Computed Tomography Scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of multiple lesions in an individual patient
Generalized Estimating Equations will be utilized.
Full Information
NCT ID
NCT02989623
First Posted
December 8, 2016
Last Updated
June 25, 2019
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT02989623
Brief Title
Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA
Official Title
A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men With Persistently Elevated PSA
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
April 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Copper Cu 64 TP3805
Other Intervention Name(s)
Cu-64-TP3805
Intervention Description
Given Intravenously
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography and Computed Tomography Scan
Other Intervention Name(s)
PET/CT SCAN, Positron Emission Tomography/Computed Tomography
Intervention Description
Undergo copper Cu 64 TP3805 PET/CT scan
Primary Outcome Measure Information:
Title
Prostate cancer detection within the prostate gland by copper Cu 64 TP3805 PET
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Incidence of multiple lesions in an individual patient
Description
Generalized Estimating Equations will be utilized.
Time Frame
Up to 3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhukar Thakur, PhD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital
Learn more about this trial
Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA
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