The National Institute for Health and Care Excellence (NICE) in the U.K. has issued a guidance for prostate cancer care that supports the use of SpaceOAR hydrogel as a protective barrier to reduce the risk of radiation damage to healthy tissues and other organs during radiation therapy.
NICE’s Interventional Procedure Guidance (IPG) now allows U.K. radiation oncologists and urologists to offer patients the option of using a hydrogel spacer like SpaceOAR to reduce the risk of radiotherapy-related side effects, including incontinence, loss of sexual function, and rectal dysfunction.
SpaceOAR hydrogel was developed by Augmenix to position the rectum wall away from the prostate during radiotherapy. By creating this temporary space, the hydrogel reduces the amount of radiation that reaches the rectum, minimizing its potentially damaging effects.
SpaceOAR hydrogel is injected in its liquid form into the space between the prostate and the rectum. It turns into a soft, solid form that pushes the prostate and the rectum apart. The spacer is stable for three months, after which it returns to liquid form and is absorbed by the body.
“We now have extensive clinical data showing that SpaceOAR hydrogel helps to significantly reduce the risk of rectal and urinary toxicities and loss of sexual function associated with radiation therapy for men with prostate cancer,” John Pedersen, president and CEO of Augmenix, said in a press release. “We are very pleased that the NICE review and IPG designation were based on data from clinical experience in hundreds of men who have been treated with SpaceOAR hydrogel around the world, and that radiation oncologists and urologists in the UK will be able to offer this proven-effective option to their patients.”
NICE’s decision was in part supported by long-term clinical data from a pivotal Phase 3 randomized trial (NCT01538628) testing SpaceOAR hydrogel. The trial was conducted in 20 centers across the United States and included 222 adult patients with invasive adenocarcinoma of the prostate who underwent image-guided, intensity-modulated radiation therapy (IG-IMRT).
After three years of follow-up, patients who used SpaceOAR had decreased rectal toxicity and fewer declines in both urinary and bowel quality of life compared with the control group.
“Radiation therapy has been proven to be a highly effective treatment option for many men with prostate cancer, but in many cases patients are concerned about potential side effects related to rectal toxicity, incontinence or sexual function,” said professor Heather Payne, a consultant in clinical oncology at University College Hospital in London. “The IPG designation provides important further validation of the benefits of a hydrogel barrier in reducing the risk of side effects, helping patients to proceed to treatment with greater comfort and confidence.”