First Use of System for Prostate-Rectum Separation in Radiation Therapy

August 16, 2010 — The first commercial use for a prostate-rectum separation system in prostate cancer patients undergoing radiation therapy has taken place. Professor Michael Eble and Dr. Michael Pinkawa of the Aachen University Hospital, Aachen, Germany, performed an implantation of SpaceOAR system. The SpaceOAR hydrogel (from spacing Organs At Risk) is a CE mark-approved system from Augmenix Inc., designed to be a tissue compatible, absorbable spacer to reduce radiation injury to healthy tissues.   "The potential for radiation injury to nearby healthy tissues is always a concern for radiation oncologists, and the SpaceOAR hydrogel is a simple, easy-to-use tool that should reduce undesirable rectal radiation in prostate cancer patients.  I look forward to using SpaceOAR hydrogel in my prostate cancer population and in other pelvic tumors such as vaginal, cervical and endometrial cancers," said Pinkawa, radiation oncologist. Since the prostate lies directly over the rectum, prostate radiation treatment always results in some rectal radiation which can lead to pain, rectal bleeding, urgency and other serious complications.  This injury potential forces a treatment compromise, between delivering enough radiation to kill the cancer and having acceptable complication rates. The Augmenix technology can alter that compromise by moving the organs at risk away from the high intensity radiation zone. SpaceOAR System is a synthetic hydrogel composed of approximately 90 percent water, with the remaining solids being cross-linked polyethylene glycol (PEG).   Injected as a liquid, the material solidifies in the body to form an absorbable hydrogel that maintains space between the prostate and rectum during radiation therapy, and then gradually liquefies and is absorbed.  In a procedure lasting minutes, Pinkawa used transrectal ultrasound guidance to inject the hydrogel through an 18-gauge needle using only a local perineal block.   "I am extremely enthusiastic about this technology and truly believe it will offer a new level of hope to men facing treatment for prostate cancer and potentially other malignancies," said Jeff Michalski, M.D., vice chairman and professor, Washington University, St. Louis, Mo. Augmenix is a privately held company based in Waltham, Mass., focused on the development and commercialization of radiation oncology products using its proprietary hydrogel technology.