Prostate Cancer
Conditions
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.
Interventions
Undergo copper Cu 64 TP3805 PET/CT scan
RADIATIONCopper Cu 64 TP3805
Given Intravenously
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET | At 3 weeks post imaging visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Incidence of Multiple Lesions in an Individual Patient | At 3 weeks post imaging procedure | Generalized Estimating Equations will be utilized to provide a total number of lesions |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy) |
|---|---|
| Age, Customized | 63.4 years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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.
Time frame: At 3 weeks post imaging visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy) | Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET | 25 Participants |
Secondary
Total Incidence of Multiple Lesions in an Individual Patient
Generalized Estimating Equations will be utilized to provide a total number of lesions
Time frame: At 3 weeks post imaging procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy) | Total Incidence of Multiple Lesions in an Individual Patient | 339 lesions |