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

World's largest radiation oncology meeting will offer full conference on interactive platform October 25-28, 2020
News | ASTRO | July 09, 2020
July 9, 2020 — Registration opens today for the American Society for Radiation Oncology's (...
Radiotherapy has been used to treat cancers for more than a century and continues to be utilized in cancer treatment plans today. Since the introduction of radiotherapy, clinicians have been working tirelessly to further refine treatments to better target cancer.
Feature | Radiation Therapy | July 06, 2020 | By Yves Archambault
Everything has room for improvement, right? Right. When it comes to cancer care, it is no different.
Proton therapy has evolved, and future predictions include smaller systems, more sophisticated proton dosimetry and devices that manipulate the proton beam
Feature | Proton Therapy | July 06, 2020 | By Minesh Mehta, M.D.
The field of proton...
Researchers reviewed results of prostate biopsies on over 3,400 men who had targets identified on prostate MRI and found that the positive predictive value of the test for prostate cancer was highly variable at different sites
News | Prostate Cancer | July 01, 2020
July 1, 2020 — Prostate MRI is an emerging technology used to identify and guide treatment for...
News | Proton Therapy | June 16, 2020
June 17, 2020 — RaySearch Laboratories AB launched the latest release of its widely adopted treatment planning system
Vacancy rates for radiation therapists rose substantially since 2018, according to a survey performed this year by the American Society of Radiologic Technologists. Researchers noted, however, the survey data was collected before the COVID-19 pandemic began affecting the surveyed clinical settings.

Getty Images

News | Radiation Therapy | June 05, 2020
June 5, 2020 — Vacancy rates for radiation therapists rose substantially since 2018, according to a survey performed