Trial Outcomes & Findings for Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA (NCT NCT02989623)
NCT ID: NCT02989623
Last Updated: 2025-04-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
At 3 weeks post imaging visit
Results posted on
2025-04-24
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA
Baseline characteristics by cohort
| Measure |
Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy)
n=25 Participants
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
|
|---|---|
|
Age, Customized
|
63.4 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 3 weeks post imaging visitThe 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.
Outcome measures
| Measure |
Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy)
n=25 Participants
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
|
|---|---|
|
Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET
|
25 Participants
|
SECONDARY outcome
Timeframe: At 3 weeks post imaging procedureGeneralized Estimating Equations will be utilized to provide a total number of lesions
Outcome measures
| Measure |
Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy)
n=25 Participants
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
|
|---|---|
|
Total Incidence of Multiple Lesions in an Individual Patient
|
339 lesions
|
Adverse Events
Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place