The SpaceOAR system is a medical device developed by Augmenix to protect against rectal injury during radiation therapy for prostate cancer. SpaceOAR, a name that stands for Spacing Organs at Risk, was cleared by the US Food and Drug Administration (FDA)  for use as an absorbable perirectal spacer.

How does SpaceOAR work?

The prostate and the rectum are situated right next to each other. Radiation therapy targeting the prostate can, therefore, damage the rectum, causing such complications as pain, rectal bleeding, and diarrhea.

The SpaceOAR system works by injecting a hydrogel into the space between the prostate and the rectum, generating a force that pushes the organs about 1 cm or 0.5 inches away from each other. This gel-induced extra space lowers the radiation dose that can affect the rectum during prostate radiation therapy, and reduces the risk of rectal injury.

The hydrogel, which is biodegradable and mostly made of water, maintains the spacing for three months, then gradually becomes a liquid that is expelled in urine about six months after injection.

Studies with SpaceOAR

Augmenix sponsored a Phase 3 clinical trial in the U.S. (NCT01538628) to evaluate the safety of the system in men undergoing image-guided-intensity-modulated-radiotherapy (IG-IMRT), and to assess whether the use of the SpaceOAR hydrogel resulted in a reduction of radiation exposure to the rectum.

Trial results found that the hydrogel spacer was safe and well-tolerated. It significantly reduced rectum radiation injury, with fewer reports of pain during radiation treatment. One year after radiation, use of the hydrogel was seen to decrease rectum complications by 71 percent, and untreated patients were 3.5 times more likely to have rectal complications than those who were treated.

In a three-year follow-up, patients given SpaceOAR prior to radiotherapy had 73.5 percent less evidence of radiation late toxicity or damage to the rectum, and better urinary function. Patients who received SpaceOAR were also eight times less likely to experience significant decline in quality of life, and 78 percent of the men who were sexually active before receiving SpaceOAR treatment were more likely to retain sexual function three years later.

A Phase 1 prospective study  (NCT02212548) to determine whether SpaceOAR reduces the dose of radiation delivered to the rectum during IG-IMRT to treat prostate cancer was conducted in Australia, and another trial is currently recruiting participants in Germany (NCT01999660).

A new U.S. study (NCT02353832) is also recruiting participants to test the effectiveness of SpaceOAR in reducing the dose of radiation delivered to the rectum during stereotactic ablative body radiation (SABR), a high-dose and precision radiation therapy used on limited-volume tumors. In this trial, patients with low-risk prostate cancer are being enrolled.

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