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

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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.

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Authors and Affiliations

  1. Genesis Cancer Care Victoria, 36 Mt Dandenong Road, Ringwood East, VIC, 3135, Australia

    Michael Chao, Huong Ho & Sandra Spencer

  2. The Austin Hospital, Heidelberg, Australia

    Michael Chao, Daryl Lim Joon, Vincent Khoo, Nathan Lawrentschuk, Yee Chan, Shomik Sengupta, Farshad Foroudi & Damien Bolton

  3. Ringwood Private Hospital, Ringwood East, Australia

    Michael Chao, Yee Chan, Kevin McMillan, Madalena Liu, George Koufogiannis & Damien Bolton

  4. University of Melbourne, Melbourne, Australia

    Vincent Khoo

  5. Monash University, Melbourne, Australia

    Vincent Khoo

  6. Royal Marsden Hospital, London, UK

    Vincent Khoo

  7. The Bays Hospital, Mornington, Australia

    Alwin Tan & Chee Wee Cham

  8. The Valley Private Hospital, Mulgrave, Australia

    Trung Pham

  9. The Box Hill Hospital, Box Hill, Australia

    Shomik Sengupta & Kevin McMillan

Authors
  1. Michael Chao
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  2. Daryl Lim Joon
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  3. Vincent Khoo
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  12. Madalena Liu
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  13. George Koufogiannis
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Contributions

MC: project development, data analysis, manuscript writing/editing. DLJ: project development, manuscript editing. VK: manuscript editing. NL: manuscript editing. HH: data management, data analysis. SS: data management. YC: data collection. AT: data collection. TP: data collection. SS: data collection. KM: data collection. ML: data collection. GK: data collection. CWC: data collection. FF: manuscript editing. DB: protocol development, manuscript editing.

Corresponding author

Correspondence to Michael Chao.

Ethics declarations

Research involving human participants

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institution and with the 1964 Helsinki declaration or comparable ethical standards.

Conflict of interest

The authors declare that they have no conflict of interest.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Chao, M., Lim Joon, D., Khoo, V. et al. The use of hydrogel spacer in men undergoing high-dose prostate cancer radiotherapy: results of a prospective phase 2 clinical trial. World J Urol 37, 1111–1116 (2019). https://doi.org/10.1007/s00345-018-2502-5

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  • DOI: https://doi.org/10.1007/s00345-018-2502-5

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