SpaceOAR™

SpaceOAR™ Hydrogel is an absorbable gel material that creates a temporary space between the prostate and the rectum, potentially reducing radiation dose to the rectum during prostate cancer radiation. It separates the prostate and rectum and is naturally absorbed by the body in about six months. More than 50,000 patients worldwide have been successfully treated with SpaceOAR™ Hydrogel.

SpaceOAR™ Hydrogel is an option for men preparing to undergo radiation treatment for prostate cancer. It is designed to reduce the radiation dose delivered to the rectum and help maintain rectal function.

Prostate cancer is the most common cancer in American men. In the United States, more than 183,000 new cases of prostate cancer are diagnosed each year. More than 60,000 American men opt for radiation treatment every year to treat their prostate cancer.

Prostate cancer is highly treatable and there are a number of treatment options available based on things like the stage of the disease, a person’s age, how healthy they are and their personal preferences. Three common options include watchful waiting to see if the tumor grows or spreads, surgery to remove the prostate, or radiation to kill cancer cells and shrink the tumors.

The side effects of prostate cancer treatment vary based on the treatment method chosen. Surgery and radiation have been shown to be the two most successful treatments for low and intermediate grade prostate cancer. The most common complications following surgery are urinary incontinence and erectile dysfunction, while the most common complications following radiation are overactive bladder symptoms, overactive bowel symptoms, or erectile dysfunction.

When treating prostate cancer patients with radiation therapy, the goal is to kill the cancer cells while avoiding damage to surrounding healthy tissue. The prostate is next to the rectum and naturally separated by a small space. Due to the proximity, prostate radiation therapy can unintentionally cause damage to the rectum, which can lead to issues with bowel function. SpaceOAR™ Hydrogel is a gel spacer that temporarily moves the rectal wall farther away from the prostate. By separating the prostate from the rectum, the radiation dose delivered to the rectum is reduced, which may lessen damage to the rectum. Clinical data demonstrated the benefits of SpaceOAR™ Hydrogel, including a reduction of rectal injury resulting in maintained bowel function and a higher likelihood to maintain urinary and sexual function.

As with any medical treatment, there are some risks involved with the use of SpaceOAR™ Hydrogel. Potential complications include, but are not limited to: pain associated with SpaceOAR™ Hydrogel injection; pain or discomfort associated with SpaceOAR™ Hydrogel; needle penetration of the bladder, prostate, rectal wall, rectum or urethra; injection of SpaceOAR™ Hydrogel into the bladder, prostate, rectal wall, rectum or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR™ Hydrogel intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency.

SpaceOAR™ Hydrogel is made up of two liquids that, when combined, form a soft gel material mostly made of water. Studies have shown that the material is biocompatible, can be used in the body without causing injury or a reaction and can be safely absorbed by the body. The material that the SpaceOAR™ Hydrogel is made from has been used in other implants such as surgical sealants used in the eye, brain and spine.

SpaceOAR™ Hydrogel can be implanted during a minimally invasive outpatient procedure in a hospital, surgery center, outpatient clinic or doctor’s office prior to the start of radiation treatment. It is typically performed in under 30 minutes.

The SpaceOAR™ Hydrogel is injected as liquid through a needle inserted between the rectum and the prostate. Placment of SpaceOAR™ Hydrogel is usually performed under local anesthetic (numbing medication) with the patient awake, but in select cases can be performed under general anesthetic (with the patient asleep).

Patients may feel a pinprick or pressure but should not feel any major discomfort. After the procedure, they may experience some temporary discomfort and/or pressure at the injection site for up to 24 hours, but most SpaceOAR™ Hydrogel patients report no prolonged discomfort and are usually able to resume their normal activities shortly after the gel is implanted.

SpaceOAR™ Hydrogel can be used in all types of radiation therapy for the prostate.

Patients are usually able to go back to normal activities no later than 24 hours after SpaceOAR™ Hydrogel is implanted.

SpaceOAR™ Hydrogel begins dissolving after about three months. After about six months, the hydrogel is fully absorbed by the body.

SpaceOAR™ Hydrogel has been evaluated in clinical studies and has been shown to be safe and effective in reducing the side effects of radiation therapy to the rectal area. In a randomized clinical study, men who underwent radiation therapy without SpaceOAR™ Hydrogel were eight times more likely to experience a decline in bowel, urinary and sexual function when compared to men who underwent radiation therapy with SpaceOAR™ Hydrogel, at a median follow-up of three years.

SpaceOAR™ Hydrogel is covered by many insurance plans and is reimbursed by Medicare on a case-by-case basis. Patients should verify their benefits with their insurance company in advance of the scheduled procedure.

To date, more than 100,000 patients around the world have been successfully treated with SpaceOAR™ Hydrogel.