Augmenix Announces Positive Five-Year Long-Term Data Highlighting Significant Bowel and Sexual Quality of Life Benefits for Prostate Cancer Patients Treated with SpaceOAR® Hydrogel
SpaceOAR hydrogel is the only FDA cleared medical device intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR hydrogel to reduce the radiation dose delivered to the anterior rectum.
The publication reports Quality of Life (QOL) outcomes from 114 patients receiving external beam radiotherapy to the prostate with 54 patients receiving SpaceOAR hydrogel prior to RT and 60 patients receiving RT without SpaceOAR hydrogel (Control). The study used the Expanded Prostate Cancer Index Composite (EPIC) survey to document patient QOL at baseline (before RT), at the last day of RT, and at 2, 17 and 63 months following RT.
Significant increases in mean bowel bother QOL scores (>10 points from baseline) were reported over 5X more often by Control patients at 17 months follow up (32% vs. 6%, p<0.01). At 5-year follow-up, 5% of SpaceOAR hydrogel treated patients reported a significantly increased mean bother score vs. 14% of Control patients (p=0.2). SpaceOAR hydrogel treated patients had significantly less moderate to big problems with bowel urgency at 17 months (0 vs 13%, p<0.01) and at 63 months (0 vs 14%, p=0.01), when compared to Control patients. Five Control patients required invasive bowel procedures compared to 1 SpaceOAR hydrogel patient (polypectomy).
A significant finding in terms of sexual QOL was also reported, with SpaceOAR hydrogel treated patients having an 8 times greater likelihood of having erections sufficient for intercourse at 5-years post-treatment (24% vs. 3% p<0.01).
“These long-term results further validate previous three-year data of the SpaceOAR System and highlight the long-term bowel and sexual Quality of Life benefits it can provide to prostate cancer patients who are treated with radiotherapy,” said Michael Pinkawa, MD, PhD, radiation oncologist at MediClin Robert Janker Klinik, Bonn, Germany and lead author of the study.
“This five-year data confirms previously reported three-year outcomes from our randomized, multi-center trial and continues to build a growing portfolio of studies supporting the use of SpaceOAR hydrogel spacing during radiotherapy for prostate cancer,” said John Pedersen, CEO of Augmenix. “We remain committed to furthering the spacing concept that we believe will help many patients return to and maintain pre-treatment quality of life following prostate radiotherapy.”
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