Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 259

Augmenix Announces Positive Clinical Trial Results Demonstrating Efficacy of SpaceOAR

Posted by fidest press agency su venerdì, 29 settembre 2017

prostateResearchers have long known that higher radiation doses (dose escalation) are more effective at killing tumors. However, the amount of radiation safely delivered to the prostate is limited by the rectum proximity, and concerns of creating long-term rectal injury and associated side effects. Physicians at the University of Texas Southwestern Medical Center and Memorial Sloan Kettering Cancer Center recently evaluated 44 men receiving SpaceOAR Hydrogel followed by dose-escalated (45 Gray) SBRT. The data show that SpaceOAR Hydrogel significantly reduces rectal injury in men undergoing high-dose SBRT for prostate cancer. Specifically, 13.6 percent of treated men had rectal mucosal injury in the study, all of which were mildly symptomatic and completely healed within six months following treatment. These findings are significant, as prior clinical research found that 90 percent of non-SpaceOAR Hydrogel patients treated with the same SBRT regimen experienced similar radiation-induced mucosal injury due to higher rectal wall radiation doses. None of the patients exhibited signs of biochemical cancer recurrence in the 12-month follow up period.“Hypofractionated approaches are gaining momentum in the treatment of prostate cancer, and in our experience, high-dose regimens have provided exceptionally high rates of biochemical control, but at the cost of an increased risk of rectal complications associated with the rectal wall dose,” said Michael Folkert, MD, radiation oncologist and brachytherapy specialist at University of Texas Southwestern Medical Center in Dallas. “Our new study demonstrates that use of the perirectal hydrogel spacer gets us the ‘room’ we need to safely deliver the most potent therapeutic doses to patients, which may ultimately lead to the optimal cancer control while significantly reducing the risk of treatment related complications.” As the first and only prostate cancer spacing device to receive Food and Drug Administration (FDA) clearance, SpaceOAR Hydrogel is placed between the prostate and rectum, protecting the rectum and surrounding tissue from high-dose radiation exposure. Long-term clinical data has shown that at both three and five years post-radiation therapy (using Intensity Modulated Radiation Therapy), patients treated with SpaceOAR Hydrogel demonstrated significant bowel, urinary and sexual function benefits.1-3
“We are excited by the successful results from this study, as it is the first time we’ve evaluated SpaceOAR Hydrogel in prostate cancer patients treated with high-dose SBRT, and the findings confirm a significant clinical benefit,” said John Pedersen, CEO, Augmenix. “As this robust data indicates – along with the other positive data on our hydrogel spacing technology presented this week at ASTRO – we remain steadfast in our vision to develop disruptive medical technology that improves the lives of patients receiving radiation therapy.”Prior SpaceOAR Hydrogel clinical studies have demonstrated significant reductions in long-term radiation side effects, and improvements in patient quality of life following the delivery of standard prostate radiation doses. This recent study was designed to see if SpaceOAR Hydrogel allows for safe prostate dose escalation, which if proven safe in other studies, has the potential to reduce cancer recurrence rates following prostate radiotherapy.For more information on SpaceOAR Hydrogel, visit http://www.SpaceOAR.com. (photo: prostate)

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