News | June 22, 2015

SpaceOAR Prostate-Rectum Spacing System Clinical Trial Shows Positive Results

Results indicate 73 percent relative reduction in rectal radiation dose during prostate radiotherapy

Augmenix, SpaceOAR, pivotal trial, prostate-rectum spacing system, positive

June 22, 2015 - Augmenix Inc. announced the publication of the 222-patient pivotal study designed to evaluate safety and efficacy of the SpaceOAR System in men undergoing prostate radiotherapy. By creating space between the prostate and rectum, the SpaceOAR System is intended to reduce the radiation dose delivered to the rectum during prostate radiotherapy. The favorable results from the multi-center, randomized, single-blind study led to the April 1, 2015, U.S. Food and Drug Administration (FDA) clearance of the SpaceOAR System.

Electronically published in International Journal of Radiation Oncology"¢Biology"¢Physics (Red Journal), the official journal of the American Society for Therapeutic Radiology and Oncology (ASTRO), the study demonstrated product safety and effectiveness. Spacer application was well tolerated by patients, and on average increased prostate-rectum space from 1.6mm to 12.6mm. This extra space reduced the average rectal V70 radiation dose (percent of rectum volume receiving 70 Gray radiation) from 12.4 percent to 3.3 percent, a 73 percent relative decline compared to the control group (no spacer). This decreased radiation led to additional key patient benefits compared to the control group, including:

  • Reduced reports of rectal pain during radiation treatment by 76 percent;
  • Reduction in rectal toxicity by 71 percent in the year following radiotherapy;
  • Reduction in percent of patients experiencing significant declines in bowel quality of life by 46 percent, as measured one year following radiotherapy.

 

"In the field of prostate radiotherapy, the rectum dose reduction seen in this trial is unprecedented," said Richard Hudes, M.D., of Chesapeake Urology and a study investigator. "This new ability to safely reduce rectum radiation may enable advanced protocols, like prostate stereotactic body radiation therapy, resulting in significant cost savings, as well as in prostate dose escalation, potentially decreasing cancer recurrence."

Historically, because the prostate lies next to the rectal wall, the rectum has been defined as the organ at risk (OAR) in men undergoing prostate radiation treatment. This close proximity means that small errors in patient positioning or movement during radiation delivery can lead to inadvertent rectal radiation, potentially resulting in long-lasting rectal toxicity (complications) like diarrhea, bleeding and pain.

The SpaceOAR System was developed to minimize the risk of rectal damage during prostate radiotherapy. It is a soft, gel-like material that temporarily moves the rectum away from the prostate during a course of radiotherapy, thus reducing the likelihood of rectum radiation injury.

"Spacer application in the study was well tolerated, the gel lasted through radiation treatment and was shown to completely absorb, leaving nothing behind," said Lawrence Karsh, M.D., a study investigator from The Urology Center of Colorado in Denver. "From the urologist perspective, a product that reduces the complications in patients selecting prostate radiotherapy is a tremendous advance that should be considered when patients are weighing treatment options."

The SpaceOAR System is also CE marked and TGA approved.

For more information: www.augmenix.com

Related Content

Gadolinium-enhanced MRI of a cardiac radiation therapy patient at baseline (left) and 3 months post-treatment (right). Top: the left ventricle with patchy, gadolinium-enhanced scar was transmurally targeted with a radiation ose of 25 Gy between 3 and 6 o’clock (red brackets). Nonenhanced, remote myocardium is adjacent to target region (white arrowhead). Bottom: surviving nonenhanced myocardium within the same images is visible in the targeted region at baseline and 3 months post-treatment (yellow outline).

Gadolinium-enhanced MRI of a cardiac radiation therapy patient at baseline (left) and 3 months post-treatment (right). Top: the left ventricle with patchy, gadolinium-enhanced scar was transmurally targeted with a radiation ose of 25 Gy between 3 and 6 o’clock (red brackets). Nonenhanced, remote myocardium is adjacent to target region (white arrowhead). Bottom: surviving nonenhanced myocardium within the same images is visible in the targeted region at baseline and 3 months post-treatment (yellow outline). See more figures from this study.

Feature | Radiation Therapy | September 28, 2021
September 28, 2021 — New research from Washington University School of Medicine in St.
The global radiotherapy devices market is expected to grow from $5.44 billion in 2020 to $5.848 billion in 2021 at a compound annual growth rate (CAGR) of 7.5%

Varian's Ethos artificial intelligence radiotherapy device.

News | Radiation Oncology | September 28, 2021
September 28, 2021 — The global radiotherapy devices market is expected to grow from $5.44 billion in 2020 to $5.848
Scientists have identified two subtypes of metastatic prostate cancer that respond differently to treatment, information that could one day guide physicians in treating patients with the therapies best suited to their disease.

Getty Images

News | Prostate Cancer | September 24, 2021
September 24, 2021 — Scientists have identified two subtypes of metastatic...
The "Global Surface Guided Radiation Therapy (SGRT) Devices Market, By Device Type (Portable v/s Fixed), By Application (Breast Cancer, Head & Neck Cancer, Abdominal & Pelvic Cancer, Dermatology, Others), By End User, By Region, Competition Forecast & Opportunities, 2026" report

Image courtesy of Varian

News | Radiation Therapy | September 24, 2021
September 24, 2021 — The ...
The National Cancer Institute announced that Virginia Commonwealth University Massey Cancer Center, Medical University of South Carolina Hollings Cancer Center and City of Hope Comprehensive Cancer Center secured a highly competitive Specialized Program of Research Excellence (SPORE) grant that aims to address lung cancer racial disparities through precision medicine, targeted smoking cessation programs and community outreach.

VCU Massey Cancer Center director and SPORE principal investigator Dr. Robert Winn explains how this grant will help combat racial inequities in lung cancer. Image courtesy of VCU Massey Cancer Center

News | Lung Imaging | September 23, 2021
September 23, 2021 — The National Cancer Institute announced tha
Paige Prostate, is the first artificial intelligence (AI)-based software designed to identify an area of interest on the prostate biopsy image with the highest likelihood of harboring cancer so it can be reviewed further by the pathologist if the area of concern has not been identified on initial review.
News | Digital Pathology | September 22, 2021
September 22, 2021 — The U.S.
The development of new research guidelines for interventional oncology that standardize treatment outcomes and the reporting of data represents a major step forward for an increasingly important medical subspecialty, according to a report in Radiology.

Getty Images

News | Radiation Oncology | September 21, 2021
September 21, 2021 — The development of new research guidelines for interventional oncology that standardize treatmen
Non-oncology doctors’ knowledge of oncology is frequently not up to date, with risks in the communication with patients  

Getty Images

News | Radiation Oncology | September 20, 2021
September 20, 2021 — The rapid pace of developments in the oncology field, mainly brought by cancer immunotherapy, me