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

SpaceOAR Hydrogel Now Available in Japan
News | Patient Positioning Radiation Therapy | July 16, 2018
Augmenix K.K. announced that SpaceOAR hydrogel, a soft, implanted absorbable gel spacer is now available to all...
RaySearch Releases New Version of RayCare OIS
Technology | Oncology Information Management Systems (OIMS) | July 13, 2018
RaySearch has released RayCare 2A, the latest version of its flagship oncology information system (OIS). RayCare is...
Lack of Insurance Coverage Delaying Proton Therapy Clinical Trials
News | Proton Therapy | July 12, 2018
Randomized clinical trials are the gold standard of cancer research and can shed light on whether innovative, new...
Bruce Power Joins Forces With ITM to Supply Lutetium-177 for Cancer Therapy
News | Radiation Therapy | July 11, 2018
Canadian nuclear power company Bruce Power and German-based Isotope Technologies Garching (ITG) signed an agreement to...
MedStar Georgetown University Hospital Now Clinical With RayStation and Hyperscan
News | Treatment Planning | July 05, 2018
MedStar Georgetown University Hospital in Washington D.C., has begun patient treatments using the RayStation treatment...
Northern Centre for Cancer Care (NCCC)

Northern Centre for Cancer Care (NCCC).

Sponsored Content | Case Study | Radiation Therapy | July 05, 2018
Established in 2009, Northern Centre for Cancer Care (NCCC) is the largest center of its kind in the north of England....
Researcher Investigates Eliminating Radiation for HER2-Positive Breast Cancer
News | Radiation Therapy | July 02, 2018
Researchers at The University of Kansas Cancer Center have launched a clinical trial that eliminates radiation from the...
SNMMI Image of the Year Highlights Theranostic Approach for Advanced Prostate Cancer

IMAGE OF THE YEAR: PSMA PET before and after lutetium-177 PSMA617 theranostics in 8 patients with metastatic prostate cancer who exhausted standard therapeutic options.

68Ga-PSMA11 PET maximum intensity projection (MIP) images at baseline and 3 months after 177Lu-PSMA617 in 8 patients with PSA decline ≥ 98 percent in a prospective phase II study. Any disease with SUV over 3 is in red. Credit: Michael Hofman, John Violet, Shahneen Sandhu, Justin Ferdinandus, Amir Iravani, Grace Kong, Aravind Ravi Kumar, Tim Akhurst, Sue Ping Thang, Price Jackson, Mark Scalzo, Scott Williams and Rodney Hicks, Peter MacCallum Cancer Centre, Melbourne, Australia.

News | PET Imaging | June 29, 2018
In the battle against metastatic castrate-resistant prostate cancer, studies have demonstrated a high response rate to...
Technology | Focused Ultrasound Therapy | June 19, 2018
EDAP TMS SA has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Focal One device for...
New Prostate Cancer Radiotherapy Technique Aims to Preserve Sexual Function
News | Radiation Therapy | June 18, 2018
A multicenter clinical trial being led by UT Southwestern physicians is testing a technique for sparing nerve bundles...
Overlay Init