News | Patient Positioning Radiation Therapy | January 16, 2017

Augmenix Announces Positive Three-Year Long-Term Data for SpaceOAR Hydrogel Spacer

Results show on average no long-term declines in bowel and urinary quality of life for patients, and 78 percent reduction in late rectal toxicity

Augmenix, SpaceOAR hydrogel spacer, three-year trial data, Red Journal, prostate cancer radiotherapy

January 16, 2017 — Augmenix Inc. announced that the International Journal of Radiation Oncology Biology and Physics (IJROBP), also known as the Red Journal, has published long-term outcomes data from the company’s Phase 3 clinical trial for SpaceOAR System. SpaceOAR is the first absorbable hydrogel spacer designed to separate the rectum and prostate during prostate cancer radiotherapy.

The Red Journal publication reports three-year post-treatment data in the Phase 3 prospective, randomized, multi-center, patient-blinded clinical trial of the SpaceOAR System. The study evaluated radiation dose to critical structures (prostate, rectum, bladder, penile bulb), rectal and urinary toxicity, and quality of life (QOL) impact on prostate cancer patients treated with and without SpaceOAR System during radiotherapy. For QOL, the Expanded Prostate Cancer Index Composite (EPIC) was utilized. The SpaceOAR System is the only product that is U.S. Food and Drug Administration (FDA)-cleared to provide a barrier between the prostate and rectum to decrease toxicity and minimize changes in QOL following prostate radiotherapy. It is injected as a liquid and then solidifies into a soft hydrogel that pushes the rectum out of the high-dose prostate radiation field for three months during radiation therapy. The hydrogel is absorbed by the body in the months following treatment.

During radiotherapy the spacer resulted in a 73.5 percent reduction in rectal V70 radiation dose, and a 49 percent reduction in median penile bulb radiation dose in patients treated with SpaceOAR (SpaceOAR) compared to men who did not receive SpaceOAR hydrogel (Control). In the three years following radiation treatment the SpaceOAR group demonstrated a 78 percent reduction in late rectal toxicity complications, compared to Control patients. No patients in the SpaceOAR group (0 percent) experienced grade two or worse rectal toxicity, compared to 5.7 percent in the Control group. Results also showed a 75 percent reduced risk of mild urinary incontinence among patients treated with SpaceOAR compared to Control. At three years, the average SpaceOAR patient bowel and urinary QOL measure was the same as before radiotherapy, while the Control patients QOL measures had significantly declined.1

Overall patient wellness at three years was also assessed by looking at the percent of patients with clinically significant declines in all three QOL areas (bowel, urinary and sexual). Fully 20 percent (one in five) of the Control patients had clinically significant QOL declines in all three QOL areas, compared to only 2.5 percent (one in forty) of the SpaceOAR patients.

“These results further validate the safety and efficacy of the SpaceOAR System and highlight the long-term benefits it can provide to prostate cancer patients who are treated with radiotherapy,” said Daniel Hamstra, M.D., Ph.D., radiation oncologist at Texas Center for Proton Therapy. “By creating a space between the rectum and prostate, SpaceOAR can help prevent risks of injury to surrounding healthy tissue during radiation, representing an important advantage for thousands of men treated for prostate cancer each year.”

For more information: www.spaceoar.com

References

1. Hamstra, D.A., Mariados, N., Sylvester, J., Shah, D., et al. "Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial." International Journal of Radiation Oncology Biology Physics. Published online Dec. 22, 2016.

Related Content

ZON-PTC in Clinical Use With RayStation 8B and Hyperscan
News | Treatment Planning | March 19, 2019
Zuid-Oost Nederland Protonen Therapie Centrum (ZON-PTC), Maastricht, Netherlands, recently treated its first patient...
Houston Methodist Hospital Acquires Focal One High-Intensity Focused Ultrasound System
News | Focused Ultrasound Therapy | March 19, 2019
EDAP TMS SA announced that Houston Methodist Hospital, one of the first hospitals in the U.S. to offer Ablatherm...
What to Expect from the Proton Therapy Market in 2019-2020
News | Proton Therapy | March 13, 2019
The number of new particle therapy rooms ordered worldwide dropped by almost 20 percent in 2018, according to a new...
Mississippi Cancer Center Combines RayStation and TomoTherapy for Prostate Cancer Case
News | Treatment Planning | March 08, 2019
Anderson Regional Cancer Center in Meridian, Miss., has treated its first patient using the combination of RaySearch's...
Videos | Proton Therapy | March 01, 2019
ITN Associate Editor Jeff Zagoudis speaks with Mark Pankuch, Ph.D., director of physics and dosimetry at the...
Videos | Proton Therapy | February 28, 2019
ITN Associate Editor Jeff Zagoudis speaks with ...
360_NW_Proton_Center_Gantry_Room_Back_THUMBNAIL
360 Photos | 360 View Photos | February 28, 2019
This is a 360 photo view behind the gantry room at the ...
360_NW_Proton_Center_Inclined_Room_THUMBNAIL
360 Photos | 360 View Photos | February 28, 2019
This is a 360 view of Treatment Room 3 (of 4) at the N...
NW Proton Center Gantry Room Front
360 Photos | 360 View Photos | February 27, 2019
This is a 360 photo view inside the gantry room at the...
Videos | Proton Therapy | February 26, 2019
ITN Associate Editor Jeff Zagoudis speaks with ...