Exploratory study in adult males with metastatic prostate cancer intended to characterize the pharmacokinetics and biodistribution of PSMA-Targeted \[In-111\]-Labeled Trillium Compounds with and without the cytoprotective agent PTI-122. Up to 36 eligible subjects will be enrolled. Additional subjects may be enrolled if there is insufficient data for evaluation, for example if the original study subjects do not complete required imaging studies for reasons unrelated to adverse events. Up to four PSMA-Targeted \[In-111\]-Labeled Trillium Compounds will be evaluated. Each compound will be evaluated first without the cytoprotective agent, PTI-122, then the \[In-111\]-labeled Trillium Compound may be co-administered with PTI-122.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
23
Radiotracer
Cytoprotective agent
Biogenix Molecular
Miami, Florida, United States
Advanced Molecular Imaging & Therapy
Glen Burnie, Maryland, United States
XCancer Omaha/Urology Cancer Center
Omaha, Nebraska, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Amount of radiotracer absorbed by tumor
Tumor uptake measured on imaging
Time frame: Over 168 hours post-injection
Amount of radioactivity in blood
Radioactivity measured pre- and post-radiotracer injection
Time frame: Over 168 hours post-injection
Amount of radiotracer absorbed by organs
Organ uptake measured on imaging
Time frame: Over 168 hours post-injection
Amount of PTI-122 in blood
PTI-122 measured pre- and post-dose
Time frame: Over 168 hours post-injection
Incidence of adverse events
Occurrence of adverse events during the study
Time frame: Over 168 hours post-injection
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