Trial reportWorld journal of urology2019
The use of hydrogel spacer in men undergoing high-dose prostate cancer radiotherapy: results of a prospective phase 2 clinical trial.
Trial report in World journal of urology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 17 citations in OpenAlex.
- Perirectal spacers and endorectal balloons in external beam radiotherapy for prostate cancer: a review of prospective studies.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026Review
- Magnetic Hydrogels as a Treatment for Oncological Pathologies.Journal of functional biomaterials · 2025Review
- Protecting organs-at-risk in cancer therapies through temporary organ displacement: a comprehensive review.Oncology reviews · 2025Review
- Perirectal spacers in radiotherapy for prostate cancer - a systematic review and meta-analysis.Contemporary oncology (Poznan, Poland) · 2025Article
- 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
- Comprehensive review of the use of hydrogel spacers prior to radiation therapy for prostate cancer.BJU international · 2023Review
- Prostate Cancer Treatment with Pencil Beam Proton Therapy Using Rectal Spacers sans Endorectal Balloons.International journal of particle therapy · 2022Article
- Stereotactic body radiation therapy for the treatment of localized prostate cancer in men with underlying inflammatory bowel disease.Radiation oncology (London, England) · 2021Article
- Perirectal hydrogel spacer placement prior to prostate radiation therapy using a probe-mounted needle guide.Clinical and translational radiation oncology · 2021Article
- Planning With Patient-Specific Rectal Sub-Region Constraints Decreases Probability of Toxicity in Prostate Cancer Radiotherapy.Frontiers in oncology · 2020Article
Corrections and comments
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Authors and funding
16 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe 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.
methodsThirty 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.
resultsAll 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.
conclusionIn 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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