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World J Urol. 2018 Sep 24. doi: 10.1007/s00345-018-2502-5. [Epub ahead of print]

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

Author information

1
Genesis Cancer Care Victoria, 36 Mt Dandenong Road, Ringwood East, VIC, 3135, Australia. Michael.Chao@genesiscare.com.au.
2
The Austin Hospital, Heidelberg, Australia. Michael.Chao@genesiscare.com.au.
3
Ringwood Private Hospital, Ringwood East, Australia. Michael.Chao@genesiscare.com.au.
4
The Austin Hospital, Heidelberg, Australia.
5
University of Melbourne, Melbourne, Australia.
6
Monash University, Melbourne, Australia.
7
Royal Marsden Hospital, London, UK.
8
Genesis Cancer Care Victoria, 36 Mt Dandenong Road, Ringwood East, VIC, 3135, Australia.
9
Ringwood Private Hospital, Ringwood East, Australia.
10
The Bays Hospital, Mornington, Australia.
11
The Valley Private Hospital, Mulgrave, Australia.
12
The Box Hill Hospital, Box Hill, Australia.

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) 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.

KEYWORDS:

Hydrogel spacer; Prostate cancer; Radiotherapy

PMID:
30251049
DOI:
10.1007/s00345-018-2502-5

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