SpaceOAR Hydrogel Clinical Publications

17,000+ Prostate Cancer Patients Treated and Over 60 Clinical Publications

Featured Publication

Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy
  • 222 patients were randomized (2:1 SpaceOAR: Control) and spacer application was well tolerated
  • The study results through 15 months showed that SpaceOAR Increased perirectal space, reduced rectal irradiation, reduced rectal toxicity severity, and decreased rates of patients experiencing declines in bowel quality of life.
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Featured Publication

Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial
  • The US pivotal study was reopened and patients were followed through to 37 months
  • The benefit of a hydrogel spacer in reducing the rectal dose, toxicity, and
    QOL declines after image guided intensity modulated radiation therapy for prostate cancer was maintained or increased providing stronger evidence for the benefit of hydrogel spacer use in prostate radiation therapy.
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Featured Publication

A multi-institutional clinical trial of rectal dose reduction via injected polyethylene-glycol hydrogel during intensity modulated radiation therapy for prostate cancer: Analysis of dosimetric outcomes.
  • The European pilot study included 52 patients across 4 sites
  • Injection of hydrogel into the prostate-rectal interface resulted in dose reductions to rectum for >90% of patients treated.
  • Rectal sparing was statistically significant across a range
    of 10 to 75 Gy and was demonstrated within the presence of significant interinstitutional variability in plan conformity, target definitions, and injection results.
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Featured Publication

Quality of life after radiation therapy for prostate cancer with a hydrogel spacer: 5-Year Results
  • The first 5-year quality of life results in a group of 54 prostate cancer patients treated with a hydrogel spacer demonstrate excellent treatment tolerability, in particular regarding bowel problems.
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A multi-institutional phase 2 trial of prostate stereotactic body radiation therapy (SBRT) using continuous real-time evaluation of prostate motion with patient-reported quality of life.

Source: Practical Radiation Oncology. 2018; 8: 40-47. Author: Jackson, WC
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Prostate cancer high-dose rate brachytherapy: a review of evidence and current perspectives.

Source: Expert Review of Medical Devices (2017) Author: Dutta et al.
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Placement of an absorbable rectal hydrogel spacer in patients undergoing low-dose-rate brachytherapy with palladium-103

Source: Brachytherapy Author: Taggar et al;
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Absorbable Hydrogel Spacer Use in Prostate Radiotherapy: A Comprehensive Review of Phase 3 Clinical Trial Published Data

Source: Urology (2017) Author: Karsh, L.
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Hydrogel spacers in prostate radiotherapy: a promising approach to decrease rectal toxicity

Source: Future Oncology Author: Padmanabhan, R
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Use of hydrogel spacer for improved rectal dose-sparing in patients undergoing radical radiotherapy for localized prostate cancer: First Canadian experience.

Source: Canadian Urological Association Journal (2017);11(12):373-375. Author: Berlin, A
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Efficacy of a Rectal Spacer with Prostate SABR

Source: British Institute of Radiology (2017) Author: King, R.
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Improvements in rectal dosimetry with introduction of SpaceOAR hydrogel spacer prior to definitive radiotherapy for prostate cancer.

Source: Journal of Medical Imaging and Radiation Oncology 2017.10.11; Abstract at The Royal Australian and New Zealand College of Radiologists 68th Annual Scientific Meeting. Author: Kleiven, H.
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Improved rectal dosimetry with the use of SpaceOAR during high-dose rate brachytherapy.

Source: Brachytherapy (2017) Author: Chang et al.
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The Rectal Dosimetric Effects of Perirectal Hydrogel Spacers in Men Undergoing Prostate Stereotactic Body Radiation Therapy (SBRT)

Source: Poster at ASTRO 2017 Meeting Author: Kataria, S.
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