Technology | April 06, 2015

FDA Clears Hydrogel to Improve Prostate Radiotherapy Outcomes

Treatment temporarily expands space between prostate and rectum to reduce radiation dose to rectum

SpaceOAR System, Augmenix, hydrogel, prostate, rectum, cancer, radiotherapy

April 6, 2015 — Augmenix Inc. announced U.S. Food and Drug Administration (FDA) clearance of the SpaceOAR System, cleared as a spacer to protect the rectum in men undergoing prostate cancer (PCa) radiotherapy. Despite many advancements in PCa radiotherapy, the close prostate-rectum proximity makes it challenging to deliver adequate radiation to the prostate without injuring the rectum (defined as the Organ At Risk - OAR). The SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for PCa.

Placed through a small needle, the hydrogel is administered as a liquid, but quickly solidifies into a soft gel that expands the space between the prostate and rectum. The hydrogel spacer maintains this space until radiotherapy is complete. The spacer then liquefies and is absorbed and cleared from the body in the patient’s urine.

“SpaceOAR hydrogel is a valuable new tool for urologists and radiation oncologists and should be instrumental in the adoption of advanced prostate cancer radiotherapy protocols,” said John Sylvester, M.D., of Lakewood Ranch Oncology in Bradenton, Florida, and a principal investigator in the SpaceOAR clinical trial. “Shielding the rectum from radiation may enable the utilization of dose escalation (more prostate radiation for improved cancer kill rates) and hypofractionation (fewer radiation treatment sessions), both of which should have substantial patient benefits and help reduce healthcare costs.”

According to the American Cancer Society and the National Cancer Institute, prostate cancer is second only to skin cancer as the most frequently diagnosed cancer in men with an estimated 220,800 new cases and 27,540 deaths in the United States in 2015 alone. Worldwide PCa is expected to grow to 1.7 million new cases and 499,000 deaths by 2030 due to the aging population. Following PCa diagnosis, treatment options are usually limited to surgery, radiotherapy or active surveillance, where no immediate therapeutic treatment occurs.

FDA clearance was granted following completion of the SpaceOAR System prospective, multicenter, randomized clinical trial. SpaceOAR patients experienced a significant reduction in rectal radiation dose and severity of late rectal toxicity when compared to control patients who did not receive SpaceOAR hydrogel. The full pivotal clinical trial results have been submitted for publication in a peer-reviewed journal and are expected to be published later this year.

The SpaceOAR System is also CE marked and TGA approved.

For more information: www.augmenix.com

Related Content

RayCare Oncology Information System Being Shown at ASTRO 2017
News | Radiation Therapy | September 20, 2017
RaySearch will be exhibiting its next-generation oncology information system (OIS) RayCare, among other highlights, at...
ProCure Proton Therapy Center New Jersey Celebrates Five-Year Cancer-Free Milestone for Prostate Cancer Patients
News | Proton Therapy | September 20, 2017
ProCure Proton Therapy Center in Somerset, N.J., recently celebrated the five-year cancer-free milestone for the first...
Varian to Showcase Latest Radiation Therapy Technologies and Software at ASTRO 2017
News | Radiation Therapy | September 19, 2017
Varian Medical Systems announced it will be demonstrating its new Halcyon platform and HyperArc high-definition...
Elekta to Highlight MOSAIQ Oncology Analytics at ASTRO Annual Meeting
News | Radiation Therapy | September 19, 2017
September 19, 2017 — Elekta will highlight its Mosaiq Oncology...
Double Targeting Ligands to Identify and Treat Prostate Cancer

The mice were imaged with small-animal PET/CT using 124I-RPS-027 (7.4 MBq [200 μCi]). Credit: JM Kelly et al., Department of Radiology, Weill Cornell Medicine, New York, NY

News | Prostate Cancer | September 14, 2017
Researchers have demonstrated a new, effective way to precisely identify and localize prostate cancer tumors while...
Clinical Trials and Cutting-Edge Radiation Oncology Research to Be Featured at ASTRO 2017
News | Radiation Therapy | September 14, 2017
The program for the 2017 Annual Meeting of the American Society for Radiation Oncology (ASTRO), Sept. 24-27 in San...
Blue Earth Diagnostics Announcing Results of FALCON PET/CT Trial at ASTRO 2017
News | PET-CT | September 13, 2017
September 13, 2017 — Blue Earth Diagnostics announced the upcoming oral presentation of initial results from the FALC
Provision Healthcare Joins RayCare Clinical Partners
News | Oncology Information Management Systems (OIMS) | September 11, 2017
Provision, located in Knoxville, Tenn., is the latest to partner with RaySearch Laboratories on the development of its...
U.K.'s NICE Supports Use of Hydrogel Spacer in Prostate Cancer Treatement
News | Patient Positioning Radiation Therapy | September 08, 2017
Augmenix Inc. announced that the National Institute for Health and Care Excellence (NICE) in the U.K. has issued...
Sponsored Content | Videos | Radiation Therapy | September 08, 2017
The new Visicoil MR is a helically-wound, flexible linear fiducial marker.
Overlay Init