SpaceOar is an absorbable hydrogel that temporarily creates space between the prostate and the rectum to help reduce the amount of radiation delivered to the rectum during prostate radiation therapy. SpaceOar Hydrogel is made of a soft gel material that is mostly water. The material used in the SpaceOar Hydrogel is commonly used in other implants, such as surgical sealants used in the eye, brain and spine. The gel is composed of biodegradable material and will be completely absorbed by the patient’s body over time.
The Benefits of SpaceOar
When treating prostate cancer with radiation therapy, the goal is to destroy cancer cells without damaging the surrounding healthy tissue. Though the prostate is naturally separated from the rectum with a small space, the rectum is still close enough to the prostate to be damaged by radiation therapy. Damage to the rectum can cause issues with bowel function, such as chronic diarrhea, urinary urgency and leakage, and rectal pain and bleeding. Reducing the rectum’s exposure to radiation can help decrease toxicity and tissue damage, and lead to fewer complications and improved quality of life for the patient.
A clinical study found that SpaceOar Hydrogel helped 66% of patients experience clinically significant declines in detectable bowel quality of life at median three years compared to control patients.
Who is a Candidate?
SpaceOar Hydrogel may be used to help prevent damage from all types of radiation therapy, including external radiation, internal radiation, stereotactic body radiation therapy (SBRT), and proton beam therapy.
Perirectal spacing procedures, such as the SpaceOar Hydrogel procedure, is reasonable and necessary when all of the following criteria are met:
- The patient has been diagnosed with invasive adenocarcinoma and/or intraductal carcinoma of the prostate and is at risk of long-term side effects following radiation therapy
- The patient does not have extracapsular extension of his prostate cancer through the Denonvilliers’ Fascia posteriorly to involve the tissues of the rectum
- The patient does not have a current perirectal disease or other anal or perianal diseases such as fistula
- The patient does not have an active inflammatory or infectious condition involving the perineum, gastrointestinal or urinary tract
- The patient does not have an urogenital abnormality that would interfere with the ability to access the injection site or place fiducial markers
- The patient does not have an gastrointestinal abnormality that would interfere with the ability to access the injection site or place fiducial markers
- The patient is not allergic to local anesthetic
- The patient does not have any underlying comorbidities (e.g. cardiac disease, pulmonary disease, etc.) and/or a high risk of bleeding.
Patients should speak to their doctor to find out if SpaceOar Hydrogel is an option for them.
What to Expect During the Procedure
The procedure may be performed under local, regional or general anesthesia. The doctor will use ultrasound imaging to inject the SpaceOar Hydrogel as liquid through a small needle. Patients may feel a pinprick or pressure, but should not feel any discomfort. Most patients don’t experience prolonged discomfort from the implanted gel.
Side Effects and Risks of SpaceOar
After the procedure, patients may experience the following complications:
- Pain associated with injection or the SpaceOar Hydrogel
- Needle penetration of the bladder, prostate, rectal wall, rectum or urethra
- Injection of SpaceOar Hydrogel into the bladder, rectal wall, prostate, rectum or urethra
- Local inflammatory reactions
- Injection of air, fluid or SpaceOar Hydrogel intravasculary
- Urinary retention
- Rectal mucosal damage
- Rectal urgency