MP78-11 PERIRECTAL HYDROGEL SPACER APPLICATION IN MEN RECEIVING PROSTATE RADIOTHERAPY: A PROSPECTIVE MULTICENTER RANDOMIZED CONTROLLED TRIAL (2015)

You have accessJournal of UrologyProstate Cancer: Localized VIII1 Apr 2015MP78-11 PERIRECTAL HYDROGEL SPACER APPLICATION IN MEN RECEIVING PROSTATE RADIOTHERAPY: A PROSPECTIVE MULTICENTER RANDOMIZED CONTROLLED TRIAL Christopher Pieczonka, Neil Mariados, John Sylvester, Phillip Aliotta, Christopher Skomra, Larry Karsh, Brian Smith, Richard Hudes, David Beyer, Steven Kurtzman, Al Tiara, Jeffrey Bogart, Alex Hsi, C. Garo Gholodian, Lee Ponsky, Rodney Ellis, Mark Logsdon, Seth Rosenthal, Kevin Forsythe, Hong Zhang, Edward Soffen, Neal Shore, Constantine Mantz, Peter Nieh, and Misop Han Christopher PieczonkaChristopher Pieczonka More articles by this author , Neil MariadosNeil Mariados More articles by this author , John SylvesterJohn Sylvester More articles by this author , Phillip AliottaPhillip Aliotta More articles by this author , Christopher SkomraChristopher Skomra More articles by this author , Larry KarshLarry Karsh More articles by this author , Brian SmithBrian Smith More articles by this author , Richard HudesRichard Hudes More articles by this author , David BeyerDavid Beyer More articles by this author , Steven KurtzmanSteven Kurtzman More articles by this author , Al TiaraAl Tiara More articles by this author , Jeffrey BogartJeffrey Bogart More articles by this author , Alex HsiAlex Hsi More articles by this author , C. Garo GholodianC. Garo Gholodian More articles by this author , Lee PonskyLee Ponsky More articles by this author , Rodney EllisRodney Ellis More articles by this author , Mark LogsdonMark Logsdon More articles by this author , Seth RosenthalSeth Rosenthal More articles by this author , Kevin ForsytheKevin Forsythe More articles by this author , Hong ZhangHong Zhang More articles by this author , Edward SoffenEdward Soffen More articles by this author , Neal ShoreNeal Shore More articles by this author , Constantine MantzConstantine Mantz More articles by this author , Peter NiehPeter Nieh More articles by this author , and Misop HanMisop Han More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2827AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Prostate-rectum proximity results in rectal irradiation during prostate radiotherapy (RT), limiting use of dose escalation and hypofractionation protocols. Absorbable perirectal spacers have been proposed to reduce rectal irradiation, although none have been studied in randomized, controlled studies. This represents the first prospective, randomized, controlled study of a perirectal spacer. METHODS In 20 centers a total of 222 men with stage T1 or T2 prostate cancer underwent prostate RT planning (Plan 1), were randomized 2:1 to receive transperineal fiducial marker and perirectal hydrogel spacer injection (149, SpaceOAR® System, Augmenix) or fiducial markers alone (73, Control), underwent additional prostate RT planning (Plan 2), followed by 79.2Gy x 44 fraction Image Guided – Intensity Modulated Radiation Therapy. Patients were followed weekly during RT, and at 3, 6, 12 and 15 months. Spacer tolerability, perirectal space creation, and impacts on rectal dose and Quality of Life (QOL) were all assessed RESULTS Baseline demographics and medical histories were similar between the Spacer and Control groups, with 99% of patients completing the study. Antibiotic prophylaxis was administered to 95.0% of patients, with 36.4%, 31.4% and 32.2% receiving general, local and other anesthesia, respectively. Spacer application was rated easy or very easy 98.7% of the time with a 99.3% success rate. There was little or no spacer sensation following application, and mild transient rectal events occurred in 10% of patients. Perirectal space was 12.6mm post-implant, 10.9mm at 12.4 weeks, with absorption at 12 months in Spacer patients. Comparing Plan 1 and Plan 2, spacer application resulted in >25% reduction in rectal V70 dose in 97.3%, with 100% and 92% of Spacer and Control patients meeting dose constraints. A lower proportion of Spacer patients had declines in bowel QOL at 6, 12 and 15 months, and in urinary QOL at 6 months. There were no adverse events attributed to the spacer device and no implant infections, rectal wall ulcerations or other more serious complications. CONCLUSIONS Hydrogel spacer application allowed for >1cm perirectal space, resulting in significant reductions in rectal RT doses and was associated with favorable radiotherapy QOL outcomes. The procedure was straightforward, repeatable, well tolerated and safe. Perirectal spacer application has the potential to improve outcomes in patients selecting RT, while also enabling advanced RT protocols © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e1006 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Christopher Pieczonka More articles by this author Neil Mariados More articles by this author John Sylvester More articles by this author Phillip Aliotta More articles by this author Christopher Skomra More articles by this author Larry Karsh More articles by this author Brian Smith More articles by this author Richard Hudes More articles by this author David Beyer More articles by this author Steven Kurtzman More articles by this author Al Tiara More articles by this author Jeffrey Bogart More articles by this author Alex Hsi More articles by this author C. Garo Gholodian More articles by this author Lee Ponsky More articles by this author Rodney Ellis More articles by this author Mark Logsdon More articles by this author Seth Rosenthal More articles by this author Kevin Forsythe More articles by this author Hong Zhang More articles by this author Edward Soffen More articles by this author Neal Shore More articles by this author Constantine Mantz More articles by this author Peter Nieh More articles by this author Misop Han More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...