Phase III Clinical Results
In a prospective, randomized, multi-center, patient-blinded, clinical trial, patients that received the breakthrough SpaceOAR® 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 work?
*Control patients experienced a clinically significant (1X MID) decline in bowel, urinary and sexual QOL 8 times more often than SpaceOAR patients.2,3
Reliable Space Creation1
- 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
- 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
- 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
- Bowel: 66% fewer SpaceOAR patients experienced clinically significant declines in detectable bowel quality of life (1X the Minimal Important Difference)2
- Urinary: 65% fewer SpaceOAR patients experienced clinically significant declines (2X the Minimal Important Difference) in detectable urinary quality of life2
- Sexual: SpaceOAR 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 patients to experience a clinically significant decline in all three quality of life domains combined (bowel, urinary and sexual)2,3
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.