SpaceOar hydrogel temporarily creates space between the prostate and the rectum to help reduce the rectum’s exposure to radiation. The soft gel material used in the SpaceOar Hydrogel is composed of biodegradable material and will be completely absorbed by the patient’s body over time.
The Benefits of SpaceOar
The goal of radiation therapy is to destroy cancer cells in the prostate without damaging the surrounding healthy tissue. Though there is already a small space between the prostate and rectum, there is still a significant risk of damage to the rectum. Damage to the rectum can cause issues with bowel function, such as chronic diarrhea, rectal pain and bleeding, and urinary urgency and leakage. Reducing the rectum’s exposure to radiation can help decrease tissue damage and toxicity, and lead to fewer complications and improved quality of life.
A clinical study found that 66% fewer SpaceOar Hydrogel patients experience clinically significant declines in detectable bowel quality of life at median three years compared to control patients. In addition, 66% fewer SpaceOar Hydrogel patients experienced clinically significant declines in detectable urinary quality of life at median three years compared to control patients.
Who is a Candidate?
SpaceOar Hydrogel may help prevent damage from all types of radiation therapy, including external radiation, stereotactic body radiation therapy (SBRT), internal radiation, and proton beam therapy.
Perirectal spacing procedures, such as the SpaceOar Hydrogel procedure, are typically required 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 experiencing 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 an underlying condition such as perirectal disease or other anal or perianal diseases such as fistula
- The patient does not have an active inflammatory or infectious condition affecting 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 a gastrointestinal abnormality that would negatively affect 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 preexisting comorbidities (e.g. cardiac disease, pulmonary disease, etc.) and/or a high risk of bleeding.
What to Expect During the Procedure
Patients may choose to have the procedure 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 some pressure, but should not feel any discomfort.
Side Effects and Risks of SpaceOar
After the procedure, patients may experience the following side effects:
- Pain at the injection site
- Needle penetration of the prostate, bladder, rectal wall, rectum or urethra
- Injection of SpaceOar Hydrogel into the prostate, bladder, rectal wall, rectum or urethra
- Local inflammatory reactions
- Injection of air, fluid or SpaceOar Hydrogel intravasculary
- Infection
- Constipation
- Rectal urgency
- Urinary retention
- Rectal mucosal damage
- Ulcers
- Necrosis
- Bleeding
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