The use of hydrogel spacer in men undergoing high-dose prostate cancer radiotherapy: results of a prospective phase 2 clinical trial

Abstract

Purpose: The purpose of this study was to determine whether the degree of prostate to rectal separation using a hydrogel spacer (HS) and its effect on decreasing rectal dose can be reproduced in the community setting. Methods: Thirty one patients with cT1-3aN0M0 prostate adenocarcinoma receiving radical radiotherapy to 78 Gy were recruited to the study. The primary endpoint was the proportion of patients achieving at least 25% reduction in volume of rectum receiving 70 Gy (rV70). Other endpoints included degree of prostate to rectum separation, HS insertion-related adverse events and the proportion of patients with grade 1 or worse acute or late gastrointestinal (GI) and genitourinary (GU) t..