Augmenix Inc. said today that long-term outcomes data from the company’s phase III clinical trial evaluating its hydrogel spacer, SpaceOAR, were published in the International Journal of Radiation Oncology Biology and Physics. The spacer is designed to separate the rectum and prostate during prostate cancer radiotherapy, according to the Waltham, Mass.-based company.
The newly published data were collected 3 years after patients were treated with the spacer in the randomized trial. The SpaceOAR is injected as a liquid and then solidifies as a soft hydrogel that pushes the rectum out of the high-dose radiation field during radiation therapy. Following treatment, the hydrogel is absorbed by the body.
Nearly 1 in 5 patients in the control arm of the trial had significant declines in their quality of life measures, compared to 1 in 40 patients who received SpaceOAR. No patients in the SpaceOAR arm experienced grade 2 or worse rectal toxicity, while 5.7% of the patients in the control arm did experience rectal toxicity. The data also showed that use of the SpaceOAR system resulted in a 78% reduction in rectal toxicity complications and a 75% reduced risk of mild urinary incontinence.
The system is the only product approved by the FDA that provides a barrier between the prostate and rectum to shield the rectum from radiation therapy.
“These results further validate the safety and efficacy of the SpaceOAR System and highlight the long-term benefits it can provide to prostate cancer patients who are treated with radiotherapy,” Dr. Daniel Hamstra, radiation oncologist at Texas Center for Proton Therapy, said in a prepared statement. “By creating a space between the rectum and prostate, SpaceOAR can help prevent risks of injury to surrounding healthy tissue during radiation, representing an important advantage for thousands of men treated for prostate cancer each year.”
“Following radiation therapy, patients often experience a decline in urinary, bowel and sexual function which in some cases can be extreme. These data show that the benefits seen in the use of SpaceOAR are durable and support the use of SpaceOAR hydrogel spacing during radiotherapy for prostate cancer with the potential to help many patients return to and maintain pre-treatment quality of life,” Augmenix CEO John Pedersen added.