The FDA has granted clearance to a hydrogel spacer for prostate cancer patients undergoing radiotherapy.
The FDA has granted clearance to the SpaceOAR System, a hydrogel spacer that protects the rectum in men undergoing radiotherapy for prostate cancer.
The SpaceOAR (Organ At Risk) System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, creating space to protect the anterior rectum from radiation exposure, says manufacturer Augmenix, Inc.
“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. FDA clearance of the SpaceOAR System represents a significant development in advancing the safety, precision, and flexibility with which prostate cancer radiotherapy can be delivered,” said John Pedersen, chief executive officer of Augmenix, in a press release from the company.
Placed through a small needle, the hydrogel is administered as a liquid, but quickly solidifies into a soft gel that expands the space between the prostate and rectum. The hydrogel spacer maintains this space until radiotherapy is complete. The spacer then liquefies and is absorbed and cleared from the body in the patient’s urine.
John Sylvester, MD, of Lakewood Ranch Oncology in Bradenton, FL and a principal investigator of the SpaceOAR clinical trial, called the SpaceOAR “a valuable new tool for urologists and radiation oncologists.”
“Shielding the rectum from radiation may enable the utilization of dose escalation and hypofractionation, both of which should have substantial patient benefits and help reduce health care costs,” Dr. Sylvester said.
FDA clearance was granted following completion of the SpaceOAR System prospective, multicenter, randomized clinical trial. SpaceOAR patients experienced a significant reduction in rectal radiation dose and severity of late rectal toxicity when compared to control patients who did not receive SpaceOAR hydrogel, the company reported. The full pivotal clinical trial results have been submitted for publication in a peer-reviewed journal and are expected to be published later this year.
The SpaceOAR System is also CE marked and approved by the Therapeutic Goods Administration.
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