|Grade 1||Grade 2||Grade 3||Grade 1||Grade 2||Grade 3|
|Genitourinary (Any)||28 (65.1%)||20 (46.5%)||1 (2.3%)||27 (64.3%)||14 (33.3%)||1 (2.4%)|
|Irritative||19 (44.2%)||16 (37.2%)||1 (2.3%)||18 (42.9%)||12 (28.6%)||0 (0.0%)|
|Obstructive||18 (41.9%)||5 (11.6%)||0 (0.0%)||14 (33.3%)||6 (14.3%)||1 (2.4%)|
|Gastrointestinal||25 (58.1%)||10 (23.3%)||0 (0.0%)||14 (33.3%)||6 (14.3%)||0 (0.0%)|
|Reproductive||14 (32.6%)||6 (14.0%)||0 (0.0%)||6 (14.3%)||6 (14.3%)||0 (0.0%)|
“This is the first prospective study to evaluate the efficacy of a temporary hydrogel spacer for patients undergoing high-dose SAbR (45 Gy in 5 fractions) for LR and IR PCa. Hydrogel spacer placement prior to high-dose SAbR treatment for LR and IR PCa increases the distance between anterior rectal wall and prostate. This increased space for dose falloff and reduction in incidental dose to the rectal wall is associated with a significant reduction in the incidence of rectal ulcer events to only 14.3% compared to prior studies, facilitating the safe delivery of high-dose SAbR. This is expected to reduce long-term rectal toxicity; there have been no (0%) high-grade (Grade ≥ 3) GI events noted on study to date.”
SBRT was not the method used in the SpaceOAR Hydrogel single-blind Phase III trial performed to evaluate dosimetric and clinical effects of SpaceOAR Hydrogel. IG-IMRT delivered at 79.2 Gy in 1.8-Gy fractions was the method used.
Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
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