A device to lower side effects of radiation treatment for prostate cancer, newly approved in the USA, has been used this month on the first patient. The device injects a temporary gel to create a space between the prostate and the rectum.
Named the SpaceOAR System (“OAR” stands for “organ at risk”), the system received FDA clearance on April 1. FDA granted clearance after a US clinical trial showing that SpaceOAR hydrogel achieved a significant reduction in rectal radiation dose and late rectal toxicity.
Despite advancements in radiation therapy for destroying prostate cancer cells, a common side-effect is damage to the rectum, which is located just below the prostate. Unintended radiation exposure to the rectum due to its proximity to the prostate target often results in complications including diarrhea, bleeding and pain.
SpaceOAR (pronounced "space oar"), developed by Augmenix, Inc., temporarily positions the front portion of the rectum away from the prostate during radiation treatment, creating space for protection. The device uses hydrogel. The gel is injected in liquid form through a needle and quickly solidifies into a soft gel to separate the two organs.
The first patient in the USA to undergo SpaceOAR outside of a clinical trial was treated April 3 by the radiation oncology team from UH Seidman Cancer Center at University Hospitals Geauga Medical Center in Northeast Ohio
Evidence suggests that by reducing radiation side effects, this method will bring two additional benefits: it opens the way to dose escalation (more prostate radiation for improved cancer kill rates) and hypofractionation (fewer radiation treatment sessions). All round, these potential benefits should improve patient experience, improve therapy outcomes, and help reduce healthcare costs.
“Shielding the rectum from radiation allows us to increase the radiation dose used to kill cancerous cells in the prostate,” said Rodney Ellis, MD, radiation oncologist at UH Seidman Cancer Center.
“The SpaceOAR System represents a significant development in advancing the safety, precision and flexibility with which prostate cancer radiotherapy can be delivered," he said. "The procedure is performed on an outpatient basis and patients are able to return home and resume their normal activities right away.”
Chardon resident David Reeves, the patient who underwent the April 3 procedure, illustrated the treatment’s success as he hurried back to his small farm that same day to finish boiling 500 gallons of maple sap. “I was so pleased that Dr. Ellis was able to offer me this new technology," Reeves said.
Dr. Ellis is using the device at UH Geauga Medical Center as well as UH Seidman Cancer Center in Cleveland’s University Circle. UH Seidman Cancer Center was involved in the clinical research for SpaceOAR.
UH Seidman Cancer Center is part of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University.
UH Geauga Medical Center is a 226-bed, non-profit acute care facility providing a full range of services to residents in Geauga, Ashtabula, Cuyahoga, Lake, Portage and Trumbull counties in Northeast Ohio.
According to company research, approved by FDA, the gel expands the space between prostate and rectal wall, normally about 3.8mm, to almost 12mm. The gel maintains this space for "about 3 months." After 6 months, all the gel has been absorbed and the space returns to normal.
Source: based on reporting from Newsroom: University Hospitals Case Medical Center and company and FDA information.