For Radiation Oncologists

In a prospective, randomized, multi-center, patient-blinded, clinical trial, patients that received the breakthrough SpaceOAR® hydrogel technology prior to their prostate cancer radiotherapy demonstrated significant rectal (bowel), urinary, and sexual benefit through 3 years of follow up. Read the full study here.

How does SpaceOAR hydrogel work?

*Control patients experienced a clinically significant (1X MID) decline in bowel, urinary and sexual QOL 8 times more often than SpaceOAR hydrogel patients.2,3

Reliable Space Creation1

MRI_Implant

  • 99% procedural success rate
  • Zero device adverse events
  • 1.3 cm space creation
  • Hydrogel lasts for 3 months and is then fully absorbed and cleared in the patient’s urine

Reduced Dose to Rectum and Penile Bulb

Dosimetry

  • 73.5% relative reduction in rectal V70 dose1
  • 48.8% relative reduction in median penile bulb dose2
  • 97.3% of subjects had at least a 25% relative reduction in V701

Resulting in Lower Late Rectal Toxicity vs Control2

Rectal Toxicity

  • 75% relative reduction in late grade 1+ rectal toxicity
  • 100% relative reduction in late grade 2+ rectal toxicity
  • Zero late grade 2+ rectal toxicity
  • 73% relative reduction in cumulative grade 1+ urinary incontinence

And Better Quality of Life (QOL) vs Control at 3 Years Follow-up

QOL

  • Bowel: 66% fewer SpaceOAR hydrogel patients experienced clinically significant declines in detectable bowel quality of life (1X the Minimal Important Difference)2
  • Urinary: 65% fewer SpaceOAR hydrogel patients experienced clinically significant declines (2X the Minimal Important Difference) in detectable urinary quality of life2
  • Sexual: SpaceOAR hydrogel patients who had erections sufficient for intercourse at baseline were 78% more likely to retain sexual function at 3 years3

Overall well-being: Control patients were 8 times more likely than SpaceOAR hydrogel patients to experience a clinically significant decline in all three quality of life domains combined (bowel, urinary and sexual)2,3

Play the Video Below to see Marcio Fagundes, MD 

demonstrate the technique of applying SpaceOAR hydrogel


1) N Mariados et al. Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate IMRT. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):971-7.

2) Hamstra D, et al. Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys; Dec. 2016 DOI

3) Hamstra D, et al. Evaluation of sexual function on a randomized trial of a prostate rectal spacer. J Clin Oncol 35, 2017 (suppl 6S; abstract 69)