Aspects of the Clinical use of the Import-Substituted Radiopharmaceutical Agent 18F-PSMA in Prostate Cancer

Abstract

One of the most common types of radionuclide studies, which are gaining traction in oncology, is positron emission tomography combined with computed tomography. The most significant and promising radiopharmaceutical agent in the radionuclide diagnosis of prostate cancer is 18F-PSMA. A high sensitivity and specificity of this radiopharmaceutical agent for prostate cancer are due to the prostate-specific membrane antigen, which is the second type of transmembrane glycoprotein with a high expression in endothelial cells during neoangiogenesis. The purpose is to develop a domestic import–substituted radiopharmaceutical agent 18F-PSMA, manufactured in the system of the Federal Medical and Biological Agency of Russia using domestic substances and excipients. Materials and methods. The syntheses were carried out on the Fastlab GE Healthcare module. This module has been repeatedly used to manufacture the radiopharmaceutical agent 18F-PSMA-1007 using original ABX cassettes. The reagent kit consisted of a vial with the precursor 18F-PSMA-1007, a vial with dimethyl sulfoxide for dissolving the precursor, and a vial with a solution of tetrabutylammonium in ethanol. Additional vials used outside the cassette and connected by connecting tubes with needles contained ethanol solutions with concentrations of 5 and 30%, a phosphate buffer solution. A QMA (quaternary methylamonium) cartridge was used to isolate fluorine-18. Sequentially connected PS-H+ and C18 extraction cartridges were used to isolate and purify the final product. Consumables included a «skeleton» with rotary valves, a housing, a three-necked reactor flask, glass vials, connecting tubes and adapters. Results. The process of synthesizing a radiopharmaceutical agent using domestic reagents was similar to the original one. A comparative analysis of the synthesis charts, a comparative analysis of the activity and yield of RFP made from domestic and imported reagents, and an assessment of radiochemical purity were carried out. The physiological and pathological distribution of the domestic radiopharmaceutical agent, as well as its comparison to the original drug, were carried out in the clinical part of the study, during which no side effects and adverse events were noted in patients. Conclusions. The radiopharmaceutical preparation made from domestic reagents using adapted technology for the original cassette is identical to the original in all quality indicators and corresponds to approved regulatory values.