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Purpose <p>Endorectal balloons (ERB) and perirectal spacers (RS) were developed to minimize rectal toxicity in prostate cancer radiotherapy. We conducted a&#xa0;review to assess available data.</p> Methods and materials <p>Literature search was conducted on 20th May, 2025, using PubMed. Prospective studies and meta-analyses assessing the efficacy of ERB and PRS on rectal toxicity were included. Risk of bias was evaluated (MINORS and Cochrane Risk of Bias). Other relevant publications, guideline recommendations and cost-effectiveness analyses were reviewed and summarized narratively.</p> Results <p>Of 112 identified records, 66&#xa0;studies met the inclusion criteria, including 44&#xa0;reports on RS (<i>n</i> = 4581 patients excluding reviews), 16&#xa0;reports on ERB (<i>n</i> = 829) and six on both RS and ERB (<i>n</i> = 105, excluding reviews). This included nine publications on RS (<i>n</i> = 383), 12&#xa0;publications on ERB (<i>n</i> = 204), and 3&#xa0;original publications on both RS and ERB (<i>n</i> = 105) reporting on dosimetry.</p> <p>For RS, most publications covered hydrogel, 11&#xa0;balloon and 7&#xa0;hyaluronic acid. 30&#xa0;publications reported follow-up data, with 8&#xa0;studies reporting a&#xa0;median follow-up ≥ 24&#xa0;months and one of more than five years. 35&#xa0;publications reported clinical outcomes. We identified 2&#xa0;RCTs. RS improves bowel QoL, but only one found a&#xa0;reduction of gastrointestinal G1 toxicity.</p> <p>For ERB, 12/16&#xa0;studies were dosimetry studies, with 4&#xa0;studies reporting clinical outcomes. One RCT was identified, with ERB providing a&#xa0;dosimetric benefit that also translates into reduced rectal late toxicity. The longest reported follow-up was 31&#xa0;months median. 7/16&#xa0;studies report 3D-conformal results. One study covering ERB and RS compared both modalities alone directly dosimetrically, showing an advantage for RS.</p> Conclusions <p>Overall, prospective data quality for different tools for rectal management is poor, especially regarding late toxicity, and particularly for ERBs. Evidence for late-toxicity superiority remains scarce. Both show benefits over not using any device at all.</p>

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Perirectal spacers and endorectal balloons in external beam radiotherapy for prostate cancer: a review of prospective studies

  • 期刊论文

  • 发表日期：

    2026年5月22日

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  • Matthias Moll,
  • Nancy P. Mendenhall,
  • Gregor Goldner,
  • Marcin Miszczyk,
  • Sushant Sushant,
  • Carola Lütgendorf-Caucig,
  • Eugen Hug,
  • William M. Mendenhall

摘要

Purpose

Endorectal balloons (ERB) and perirectal spacers (RS) were developed to minimize rectal toxicity in prostate cancer radiotherapy. We conducted a review to assess available data.

Methods and materials

Literature search was conducted on 20th May, 2025, using PubMed. Prospective studies and meta-analyses assessing the efficacy of ERB and PRS on rectal toxicity were included. Risk of bias was evaluated (MINORS and Cochrane Risk of Bias). Other relevant publications, guideline recommendations and cost-effectiveness analyses were reviewed and summarized narratively.

Results

Of 112 identified records, 66 studies met the inclusion criteria, including 44 reports on RS (n = 4581 patients excluding reviews), 16 reports on ERB (n = 829) and six on both RS and ERB (n = 105, excluding reviews). This included nine publications on RS (n = 383), 12 publications on ERB (n = 204), and 3 original publications on both RS and ERB (n = 105) reporting on dosimetry.

For RS, most publications covered hydrogel, 11 balloon and 7 hyaluronic acid. 30 publications reported follow-up data, with 8 studies reporting a median follow-up ≥ 24 months and one of more than five years. 35 publications reported clinical outcomes. We identified 2 RCTs. RS improves bowel QoL, but only one found a reduction of gastrointestinal G1 toxicity.

For ERB, 12/16 studies were dosimetry studies, with 4 studies reporting clinical outcomes. One RCT was identified, with ERB providing a dosimetric benefit that also translates into reduced rectal late toxicity. The longest reported follow-up was 31 months median. 7/16 studies report 3D-conformal results. One study covering ERB and RS compared both modalities alone directly dosimetrically, showing an advantage for RS.

Conclusions

Overall, prospective data quality for different tools for rectal management is poor, especially regarding late toxicity, and particularly for ERBs. Evidence for late-toxicity superiority remains scarce. Both show benefits over not using any device at all.