Phase 1 Biodistribution and Pharmacokinetic Study of 18F-DCFBC PSMA Based PET in Patients With Advanced Prostate Cancer
Prostate cancer is the most common cancer among men in the United States. Through early
detection and improved local therapies a large number of men will be cured. The clinical
needs include early detection, accurate initial staging and detection of local recurrence or
metastases in order to permit application of the most appropriate therapy. Therapeutic
monitoring and prognostic assessment are equally important. Imaging can play an important
and crucial role in meeting these clinical needs.
Positron emission tomography (PET) imaging has gained an important role in the clinical
management of cancer patients. 18F-DCFBC is a novel low molecular weight prostate specific
membrane antigen (PSMA)-based radiopharmaceutical which is radiolabeled with a fluorine-18
positron emitter for PET imaging. Preclinical mouse prostate cancer tumor model imaging
studies of 18F-DCFBC demonstrate high specific uptake in PSMA expressing prostate cancer
cells. The investigators will assess the hypothesis that 18F-DCFBC, a new positron emission
tomography (PET) radiopharmaceutical may possess pharmacokinetic and pharmacodynamic
properties that will represent an advance in imaging prostate cancer. This initial phase I
study will determine the biodistribution, pharmacokinetics, and prostate specific tumor
uptake in patients with metastatic prostate cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Serial PET scans will be used to obtain biodistribution and radiation dosimetry calculations.
Time-activity curves (TACs) demonstrating radiotracer activity as a function of time post injection (minutes) will be drawn for the whole body and the following organs: brain, breast, gallbladder, stomach, pancreas, heart wall, lung, liver, bladder, muscle, pancreas, red marrow, spleen, adrenals, upper large intestine, lower large intestine, small intestine, thymus, thyroid, testes and ovaries.Organ specific mean radiation-absorbed dose estimates for 18F-DCFBC will be calculated from the individual organ residence times. The OLINDA software package will be used to perform the absorbed dose.
Steve Cho, MD
Johns Hopkins University
United States: Food and Drug Administration
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