FDA Approves Spacing Device for PCa Radiotherapy

The FDA has approved SpaceOAR, a temporary injectable gel that creates a buffer between the prostate gland and the rectum to shield rectal tissue during external beam radiation therapy (EBRT) of prostate cancer. After radiotherapy, the spacer liquefies and is absorbed and cleared from the body in the patient's urine.

“For years, hydrogel products have been used safely to protect the most sensitive parts of the body as sealants and adhesion barriers, and now prostate cancer patients will also be able to benefit,” said John Pedersen, chief executive officer, of Augmenix, the device's manufacturer in a news release.

SpaceOAR reduces side effects from radiation exposure to the rectum, such as diarrhea and fecal incontinence. It also potentially allows a higher dose of radiation to be used during radiotherapy and fewer treatment sessions.

Full clinical trial results are expected to be published in a medical journal later this year.

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