Authors' objectives: External beam radiation therapy (RT) is a standard treatment option for clinically localized prostate cancer. The evidence supporting dose escalation in prostate cancer is well-established, with improved biochemical outcomes, local control, and disease-free survival with doses above 70 grays (Gy). However, rectal toxicity is a major concern with external RT. Studies have shown that depending on the dose, volume of radiation, and the type of RT, the rectum can be compromised, with some reports of grade II and higher gastrointestinal (GI) toxicity at 20% to 30% in patients undergoing RT for prostate cancer. Creation of a safety space margin of 4 to 10 millimeters between the prostate and rectum is purported to decrease the risk of rectal toxicity during prostate RT. Description of Technology: This health technology assessment focuses on the use of an absorbable perirectal spacer (APS) (SpaceOAR; Augmenix Inc.) in men undergoing RT for prostate cancer. The APS is a polyethylene glycol hydrogel that is injected under local anesthesia with transrectal ultrasound guidance into a space between the prostate and rectum. The APS is injected via dual syringes attached to a Y-connector to allow for the 2 precursor agents to mix while being injected. This APS polymerizes into a solid spacer within 10 seconds following injection and is said to maintain its structure for 3 months before it starts to slowly hydrolyze and is cleared from the body via the kidneys, with only traces remaining by 6 months. Patient Population: The APS is intended for use in men undergoing RT for localized prostate cancer. Clinical Alternatives: Clinical alternatives to using a hydrogel spacer such as the APS include an inflatable balloon, human collagen, or hyaluronic acid to create a protective space and potentially reduce radiation to the rectum.

Project Status: Completed

Year Published: 2016

URL for published report: The report may be purchased from:http://www.hayesinc.com/hayes/crd/?crd=31806

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: HAYES, Inc.

Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218

Contact Name: saleinfo@hayesinc.com

Contact Email: saleinfo@hayesinc.com

Copyright: <p>HAYES, Inc.</p>