SpaceOAR Hydrogel Helping to Reduce The Side-Effects Of Prostate Cancer Radiation Therapy
SpaceOAR hydrogel is an implantable medical device available for men who are due to undergo radiation treatment for prostate cancer, such as an external beam (photon or proton) and brachytherapy (LDR or HDR). SpaceOAR is a soft gel which provides space between the rectum and the prostate, making it much less likely that the surrounding organs (such as the rectum) are exposed to radiation. It is implanted utilising a minimally invasive procedure before the start of radiation treatment. Patients may be implanted under general or local anesthesia. It remains stable during radiation therapy and then is naturally absorbed by the body after radiation therapy has been completed.
✓ Minimally Invasive. Implanted with one 18G needle, it does not require a surgical scalpel or dilator. SpaceOAR can be inserted with general or local anaesthesia, facilitating a day case procedure.1
✓ Consistent Spacing. SpaceOAR is a soft hydrogel that creates on average over 1cm of space for the duration of radiotherapy.2
✓ Clinically Proven. SpaceOAR is the only hydrogel marketed to create space between the prostate and rectum for men with prostate cancer receiving radiation. It is available in the United Kingdom and a growing number of European and International markets.
✓ Clinically Supported. Our team of dedicated international clinical specialists provide clinicians with application training through a certification programme.
SpaceOAR hydrogel received positive NICE guidance in 2017. Clinical studies in Europe and the U.S. have demonstrated that the hydrogel is safe and that the space created significantly reduces the radiation delivered to the rectum. The randomised SpaceOAR hydrogel U.S. Clinical Trial has shown that patients who received the hydrogel spacer had a 74% relative reduction in rectal V70 3
Results from the randomized clinical trial demonstrated the following:
- Bowel: 66% fewer SpaceOAR hydrogel patients experienced clinically significant declines in detectable bowel quality of life (1X the Minimal Important Difference) at median 3 years compared to control patients5
- Urinary: 66% fewer SpaceOAR hydrogel patients experienced clinically significant declines (2X the Minimal Important Difference) in detectable urinary quality of life at median 3 years compared to control patients5
- Sexual: SpaceOAR hydrogel patients who had erections sufficient for intercourse at baseline were 78% more likely to retain sexual function at median 3 years compared to control patients7
1. Montoya J, Gross E, Karsh L. How I Do It: Hydrogel spacer placement in men scheduled to undergo prostate radiotherapy. Can J Urol 2018; 25(2):9288-9293.
2. Mariados N, et al; 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. International Journal of Radiation Oncology Biology and Physics (2015); 92(5): 971-977
3. King RB, Osman SOS, Fairmichael C, Irvine DM, Lyons CA, Ravi A, et al. Efficacy of a rectal spacer with prostate SABR—first UK experience. Br J Radiol 2018; 91: 20170672.
4. Kataria S, The Rectal Dosimetric Effects of Perirectal Hydrogel Spacers in Men Undergoing Prostate Stereotactic Body Radiation Therapy (SBRT), October 1, 2017Volume 99, Issue 2, Supplement, Page E676
5. 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
6. Hamstra D, et al. Evaluation of sexual function on a randomized trial of a prostate rectal spacer. J Clin Oncol 35, 2017
7. Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial. Hamstra, Daniel A. et al. Practical Radiation Oncology , Volume 8 , Issue 1 , e7 – e15