Methodological aspects of implantation of a Russian prostate-rectum spacer based on stabilized hyaluronic acid of non-animal origin

Abstract

Over the past few years, the use of spacers to optimize radiation treatment of prostate cancer has become increasingly popular in radiotherapy practice. In Russia, the experience of clinical application of this technology is small and limited to few trials at federal centers. The technique of perineal implantation of a biodegradable spacer is invasive and requires the participation of specialists with appropriate manual skills. Therefore, informing urologists, urologic oncologists, and interventional radiologists on the methodological aspects of this procedure has significant practical importance.The purpose of this work is to describe the methodology of using a new Russian medical device as a biodegradable spacer – a monophasic implantable gel (hydrogel) based on stabilized (cross-linked) hyaluronic acid of non-animal origin (EsteFILL intim), which makes it possible to reduce radiation exposure to the anterior wall of the rectum and has other positive effects (increased accuracy of radiation delivery, reduced risks of radiation-induced erectile dysfunction) in different radiotherapy methods of prostate cancer treatment. The described procedure was developed and approved at the Department of Radiotherapy of the N.N. Petrov National Medical Research Center of Oncology. The design of the study implying implantation of the stabilized non-animal hyaluronic acid (EsteFILL intim) was approved by the local ethics committee (protocol No. 16 dated 21.09.2023) and approved as a promising research work at the meetings of the Problem Commission (protocol No. 125 dated 25.09.2023) and the Academic Council of the N.N. Petrov National Medical Research Center of Oncology (protocol No. 8 dated 26.09.2023).