Lawrence Karsh, Eric Gross, Christopher M Pieczonka, Philip J Aliotta, Christopher J Skomra, Lee E Ponsky, Peter T Nieh, Misop Han, Daniel A Hamstra, Neal D Shore
OBJECTIVES: To provide an update on SpaceOARĀ® System, a FDA approved hydrogel indicated to create distance between the prostate and rectum which has been studied in phase 2 and 3 clinical trials. Here we review and summarize these clinical results including: the safety of prostate-rectum spacer application technique, the implant quality and resulting rectal dose reduction, acute and long term rectal, urinary and sexual toxicity as well as patient reported outcomes. METHODS: A prospective, randomized patient-blinded clinical study was performed comparing image-guided intensity modulated prostate radiotherapy (IG-IMRT) (79...
November 23, 2017: Urology