TY - JOUR
T1 - The use of hydrogel spacer in men undergoing high-dose prostate cancer radiotherapy
T2 - results of a prospective phase 2 clinical trial
AU - Chao, Michael
AU - Lim Joon, Daryl
AU - Khoo, Vincent
AU - Lawrentschuk, Nathan
AU - Ho, Huong
AU - Spencer, Sandra
AU - Chan, Yee
AU - Tan, Alwin
AU - Pham, Trung
AU - Sengupta, Shomik
AU - McMillan, Kevin
AU - Liu, Madalena
AU - Koufogiannis, George
AU - Cham, Chee Wee
AU - Foroudi, Farshad
AU - Bolton, Damien
PY - 2019/6
Y1 - 2019/6
N2 - 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) toxicity. Results: All patients had successful insertion of their HS with no peri-operative toxicity. The mean prostate–rectal separation achieved was 10.5 mm. Twenty nine (93.5%) patients achieved a reduction in rV70 of at least 25%. Acute grade 1 GI toxicity was reported in 3 patients. All symptoms had resolved by 3 months post RT. Late grade 1 GI toxicity was reported in one patient (3.2%) with bowel frequency occurring at 6 months and resolving by 12 months post RT. There was no grade 2 or 3 acute or late GI toxicity seen. Conclusion: In conclusion, this study illustrates that the application and benefits of HS on reducing GI rectal dose endpoints and toxicities during prostate cancer RT can be reliably replicated in a community setting similar to centres participating in the randomised trial under high quality assurance trial monitoring.
AB - 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) toxicity. Results: All patients had successful insertion of their HS with no peri-operative toxicity. The mean prostate–rectal separation achieved was 10.5 mm. Twenty nine (93.5%) patients achieved a reduction in rV70 of at least 25%. Acute grade 1 GI toxicity was reported in 3 patients. All symptoms had resolved by 3 months post RT. Late grade 1 GI toxicity was reported in one patient (3.2%) with bowel frequency occurring at 6 months and resolving by 12 months post RT. There was no grade 2 or 3 acute or late GI toxicity seen. Conclusion: In conclusion, this study illustrates that the application and benefits of HS on reducing GI rectal dose endpoints and toxicities during prostate cancer RT can be reliably replicated in a community setting similar to centres participating in the randomised trial under high quality assurance trial monitoring.
KW - Hydrogel spacer
KW - Prostate cancer
KW - Radiotherapy
UR - http://www.scopus.com/inward/record.url?scp=85053815681&partnerID=8YFLogxK
U2 - 10.1007/s00345-018-2502-5
DO - 10.1007/s00345-018-2502-5
M3 - Article
AN - SCOPUS:85053815681
SN - 0724-4983
VL - 37
SP - 1111
EP - 1116
JO - World Journal of Urology
JF - World Journal of Urology
IS - 6
ER -