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

2019-06

Chao, Michael

Lim Joon, Daryl

Khoo, Vincent

Lawrentschuk, Nathan

Ho, Huong

Spencer, Sandra

Chan, Yee

Tan, Alwin

Pham, Trung

Sengupta, Shomik

McMillan, Kevin

Liu, Madalena

Koufogiannis, George

Cham, Chee Wee

Foroudi, Farshad

Bolton, Damien M

Hydrogel spacer

Prostate cancer

Radiotherapy

Journal Article

0000-0002-5145-6783

0000-0002-3497-3746

0000-0001-8553-5618

0000-0003-3357-1216

0000-0001-8387-0965

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10.1007/s00345-018-2502-5

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. 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. 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. 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.

link

World Journal of Urology 2019; 37(6): 1111-1116

World Journal of Urology