Trial reportRadiation oncology (London, England)2021
Phase II study of stereotactic body radiotherapy with hydrogel spacer for prostate cancer: acute toxicity and propensity score-matched comparison.
Trial report in Radiation oncology (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Does biodegradable peri-rectal spacer mitigate treatment toxicities in radiation therapy for localised prostate cancer-a systematic review and meta-analysis.Prostate cancer and prostatic diseases · 2025Pooled it
- Pooled it
- Diabetes mellitus as a potential risk factor for severe late toxicity after stereotactic body radiotherapy for prostate cancer: a large single-institution cohort study.Journal of radiation research · 2026Article
- Hydrogel Spacer Insertion Prior to Stereotactic Body Radiation Therapy to the Prostate: A Comparative Study.Advances in radiation oncology · 2026Article
- Narrative review of focal boost to intraprostatic dominant lesion in intensity-modulated radiation therapy for localized or locally advanced prostate cancer.International journal of clinical oncology · 2025Review
- Perirectal spacers in radiotherapy for prostate cancer - a systematic review and meta-analysis.Contemporary oncology (Poznan, Poland) · 2025Article
- Relationship between hydrogel spacer distribution and dosimetric parameters in linear-accelerator-based stereotactic body radiotherapy for prostate cancer.Journal of applied clinical medical physics · 2024Article
- Article
- One-year clinical outcomes of MR-guided stereotactic body radiation therapy with rectal spacer for patients with localized prostate cancer.World journal of urology · 2024Article
- Efficacy of an Esophageal Spacer for Spine Radiosurgery: First Experience.Practical radiation oncologyArticle
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
backgroundThe efficacy of a hydrogel spacer in stereotactic body radiotherapy (SBRT) has not been clarified. We evaluated the safety and efficacy of SBRT in combination with a hydrogel spacer for prostate cancer.
methodsThis is a prospective single-center, single-arm phase II study. Prostate cancer patients without lymph node or distant metastasis were eligible. All patients received a hydrogel spacer insertion, followed by SBRT of 36.25 Gy in 5 fractions with volumetric modulated arc therapy. The primary endpoint was physician-assessed acute gastrointestinal (GI) toxicity within 3 months. The secondary endpoints were physician-assessed acute genitourinary (GU) toxicity, patient-reported outcomes evaluated by the EPIC and FACT-P questionnaires, and dosimetric comparison. We used propensity score-matched analyses to compare patients with the hydrogel spacer with those without the spacer. The historical data of the control without a hydrogel spacer was obtained from our hospital's electronic records.
resultsForty patients were enrolled between February 2017 and July 2018. A hydrogel spacer significantly reduced the dose to the rectum. Grade 2 acute GI and GU toxicity occurred in seven (18%) and 17 (44%) patients. The EPIC bowel and urinary summary score declined from the baseline to the first month (P < 0.01, < 0.01), yet it was still significantly lower in the third month (P < 0.01, P = 0.04). For propensity score-matched analyses, no significant differences in acute GI and GU toxicity were observed between the two groups. The EPIC bowel summary score was significantly better in the spacer group at 1 month (82.2 in the spacer group and 68.5 in the control group).
conclusionsSBRT with a hydrogel spacer had the dosimetric benefits of reducing the rectal doses. The use of the hydrogel spacer did not reduce physician-assessed acute toxicity, but it improved patient-reported acute bowel toxicity.
trial registrationTrial registration: UMIN-CTR, UMIN000026213. Registered 19 February 2017, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029385 .
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