Peer Reviewed Papers
A significant body of literature exists supporting the safety and effectiveness of SpaceOAR hydrogel.
US Clinical Study Publications
Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial
Daniel A. Hamstra, MD, PhD, Int J Radiat Oncol Biol Phys. Dec 2015, Article in Press – 2016 Dec 24
Hydrogel Spacer Application Technique, Patient Tolerance and Impact on Prostate Intensity Modulated Radiation Therapy: Results from a Prospective, Multicenter, Pivotal Randomized Controlled Trial
Pieczonka CM, et al. Urology Practice March 2016Volume 3, Issue 2, Pages 141–146
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
Mariados N, et al. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):971-7. doi: 10.1016/j.ijrobp.2015.04.030. Epub 2015 Apr 23
Daniel Hamstra, MD, PhD, et al. Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/ prostate spacer: Secondary analysis of a phase III trial, Practical Radiation Oncology 2017.
Hydrogel spacer distribution within the perirectal space in patients undergoing radiotherapy for prostate cancer: Impact of spacer symmetry on rectal dose reduction and the clinical consequences of hydrogel infiltration into the rectal wallFischer-Valuck BW, Chundury A, Gay H, Bosch W, Michalski J.
Pract Radiat Oncol. 2016 Oct 17. pii: S1879-8500(16)30222-3. doi: 10.1016/j.prro.2016.10.004. [Epub ahead of print]
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 TherapyMariados N, et al. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):971-7. doi: 10.1016/j.ijrobp.2015.04.030. Epub 2015 Apr 23
Prostate volume and biopsy tumor length are significant predictors for classical and redefined insignificant cancer on prostatectomy specimens in Japanese men with favorable pathologic features on biopsyYashi et al. BMC Urology 2014, 14:43
Low rectal toxicity after dose escalated IMRT treatment of prostate cancer using an absorbable hydrogel for increasing and maintaining space between the rectum and prostate: Results of a multi-institutional phase II trialUhl M, et al. Radiotherapy & Oncology –2013 Feb;106(2):215-9