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
  • Level 1 Clinical Evidence IMRT study
  • Easy, safe space creation without complications
  • ~1.26 cm of space measured at mid gland with SpaceOAR hydrogel
  • Rectal dosimetry improved significantly with SpaceOAR hydrogel
  • Significant improvement in Grade 1 & 2+ rectal toxicity
  • Gel absorption confirmed at 12 months via MRI
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Featured Publication

Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial
  • Level 1 Clinical Evidence IMRT study
  • Significant improvement in Grade 1 & 2+ rectal toxicity
  • Improved bowel QoL in SpaceOAR hydrogel vs Control
  • SpaceOAR hydrogel patients 8 times less likely to experience QoL declines in all 3 domains vs Control
  • Rectal dosimetry improved significantly with SpaceOAR hydrogel
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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.
  • Multi-center European pilot study
  • Evaluated relationship between spacer placement, space creation, and significant dose reduction
  • Validated SpaceOAR hydrogel procedure and transperineal approach
  • Gel absorption confirmed at 6 months via MRI
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Featured Publication

Quality of life after radiation therapy for prostate cancer with a hydrogel spacer: 5-Year Results
  • Rectal dosimetry improved significantly with SpaceOAR hydrogel
  • Sexual QoL improved significantly with SpaceOAR hydrogel
  • Bowel QoL improved significantly with SpaceOAR hydrogel
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Prospective analysis of hydrogel spacer for prostate cancer patients undergoing radiotherapy

Source: BJU International (2018) Author: Chao et al.
  • Rectal dosimetry improved significantly with SpaceOAR hydrogel
  • Treatment planning performed using CT
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Placement of an absorbable rectal hydrogel spacer in patients undergoing low-dose-rate brachytherapy with palladium-103

Source: Brachytherapy (2018); 17(2): 251-258 Author: Taggar et al.
  • Analysis of seed movement pre-/post- SpaceOAR hydrogel showed no significant change in urethral dose
  • Rectal dosimetry improved significantly with SpaceOAR hydrogel
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Improved rectal dosimetry with the use of SpaceOAR during high-dose rate brachytherapy.

Source: Brachytherapy (2018); 17(2); 259-264 Author: Chang et al.
  • Prostate HDR with and without SpaceOAR hydrogel
  • Rectal dosimetry improved significantly with SpaceOAR hydrogel
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Prostate cancer high-dose rate brachytherapy: a review of evidence and current perspectives.

Source: Expert Review of Medical Devices (2018); 15(1): 71-79 Author: Dutta et al.
  • Prostate HDR with and without SpaceOAR hydrogel
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Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase III trial

Source: Practical Radiation Oncology (2018); 8(1): e7-e15 Author: Hamstra, D.A.
  • Level 1 Clinical Evidence IMRT study
  • Penile bulb dosimetry improved significantly with SpaceOAR hydrogel
  • Improved penile bulb dosimetry associated with increased sexual QoL with SpaceOAR hydrogel
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Hydrogel spacers in prostate radiotherapy: a promising approach to decrease rectal toxicity

Source: Future Oncology (2017); 13(29): 2697-2708 Author: Padmanabhan, R. et al.
  • Literature review including SpaceOAR hydrogel procedure, safety and toxicity outcomes
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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. et al.
  • Level 1 Clinical Evidence IMRT study
  • Easy, safe space creation without complications
  • Literature review including SpaceOAR hydrogel procedure, safety and toxicity outcomes
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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. et al.
  • First Canadian Experience
  • Single center prostate SBRT with SpaceOAR hydrogel
  • SpaceOAR hydrogel well placed and well tolerated using local-anesthetic procedure
  • Hypofractionated rectal dosimetry improved significantly with SpaceOAR hydrogel
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Efficacy of a Rectal Spacer with Prostate SABR

Source: British Institute of Radiology (2017); 91(1083) Author: King, R. et al.
  • First UK Experience
  • Hypofractionated rectal dosimetry improved significantly with SpaceOAR hydrogel
  • SpaceOAR hydrogel well placed and well tolerated using local-anesthetic procedure
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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. et al.
  • Hypofractionated rectal dosimetry improved significantly with SpaceOAR hydrogel
  • PTV coverage increased with use of SpaceOAR hydrogel
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