The purpose of this study is to see if a new diagnostic research agent named 89Zr-DFO-MSTP2109A can show prostate cancer tumors on a PET scan; as well as see how long 89Zr-DFO-MSTP2109A lasts in the blood when given in small amounts. DFO-MSTP2109A is an antibody that works against STEAP1 - found on the surface of prostate cancer cells. Attached to the DFO-MSTP2109A is a radioactive material called 89ZR, which allows it to be imaged by a PET scanner. The results of this study may help researchers know whether 89Zr-DFO-MSTP2109A can be used as a diagnostic agent for finding prostate cancer that have STEAP1 on its surface with a PET scanner. The reason why identifying STEAP1 on prostate cancer cells is that new therapies are being developed to target STEAP1 prostate cancer cells.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
19
If you are enrolled onto Group 1: Once you are given the diagnostic agent, the following procedures will be done: PET scans at the approximate times: * 1-4 hours after the injection * 24 hours after the injection (the next day, Day 2) * 48-120 hours after the injection (on either Day 3, 4, or 5) * 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days, * Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection. * At each time of your scheduled PET scan.
If you are enrolled onto Group 2: Once you are given the study drug, the following procedures will be done: You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (\~ 3-7 days after injection). No research blood work will be drawn in Group 2
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging
Antibody imaging will be considered feasible if 75% of the patients are antibody-imaging-positive. We will enroll 6 patients (cohort 1A) at the 10mg dose level for an initial decision on feasibility. If 4 or more of these patients have 20% or more of their active lesions detectable by 89Zr-DFO-MSTP2109A then we will consider the agent feasible for imaging, otherwise we will proceed to cohort 1B. If the true feasibility rate is 40%, this rule will affords more than 82% chance that cohort 1B will be opened for enrollment; this probability is less than 17% if the true feasibility is 75%.
Time frame: 2 years
Number of Participants Evaluated for AEs
All participants will be evaluated for adverse events which will be graded for intensity on a scale of 0 to 5. Severity grades will be recorded and based on the CTCAE v4.0. Adverse events will be defined graded using CTCAE V4.0.
Time frame: 2 years
Rate of Clearance of Tracer 89Zr-DFO-MSTP2109A
Serial blood draws will be used to estimate the pharmacokinetic profile of the 10mg 89Zr-DFO-MSTP2109A in this patient population. Blood samples will be obtained in green top tube: Just prior to injection of 89Zr-DFO-MSTP2109A (baseline)Approximately 5 ± 2, 15 ± 5, 30 ± 9, 60 ± 19, and 120 to 240 minutes after injection of the tracer. One sample at the time of each subsequent day of imaging (24 + 8h, \~48-96h and \~120-168h post injection).
Time frame: up to 168 hours
Biodistribution/SUVmax
A PET-CT scan extending from top of skull to mid thighs will be performed to determine the biodistribution/SUVmax in bone and soft tissue
Time frame: 2 years
Percentage of Histologically Positive Lesions That Were True Positive on PET Imaging
Ability of 89Zr-DFO-MSTP2109A PET to detect sites of metastatic prostate cancer.
Time frame: 2 years
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