SpaceOAR System


 

Because of the close proximity of the prostate to the rectum, prostate radiation therapy typically results in some radiation hitting the rectum, which can cause side effects, such as pain during bowel movements, rectal urgency, bleeding, or loose stools during or after radiation treatment. That’s why the rectum is called the Organ At Risk (OAR) during prostate radiation therapy.

SpaceOAR System reduces rectal injury in men receiving prostate cancer radiation therapy by acting as a spacer: pushing the rectum away from the prostate and out of the high-dose radiation region.

 

What is radiation therapy for the treatment of prostate cancer?

Radiation therapy is a noninvasive treatment technique that uses high-energy rays or particles to kill cancer cells. It is a common and highly effective treatment for prostate cancer.

 

What are the different types of radiation therapy?

  • External Beam Radiation Therapy (EBRT): EBRT is a form of radiation therapy in which radiation beams are focused on the cancer from a machine outside the body. There are two types of EBRT: intensity modulated radiation therapy (IMRT) and stereotactic body radiation therapy (SBRT). IMRT is the most common form of EBRT used today. During IMRT treatment, a computer-driven machine moves around the patient as it delivers radiation, shaping the radiation beams and adjusting the beam’s intensity as it moves. This allows doctors to limit the dose to normal tissues and deliver higher doses of radiation to the tumor. SBRT uses advanced image guidance systems to deliver large doses of radiation to a certain area. Treatment with IMRT takes place over several weeks, while treatment with SBRT generally lasts only several days.
  • Proton Beam Radiation Therapy: Unlike other forms of radiation therapy that use X-ray beams, proton beam radiation therapy focuses beams of protons on the cancer. While this treatment option uses a different form of energy to treat prostate cancer, the proton beams are aimed using techniques similar to EBRT.
  • Brachytherapy: Also known as internal radiotherapy, brachytherapy is a form of radiotherapy where a radiation source is placed directly into the prostate.

 

What are the side effects from radiation therapy treatment?

The most common side effect of prostate cancer radiation treatment is damage to the rectum, which is located just below the prostate. In up to 85% of cases, prostate tumors form in the lower part of the prostate in the area closest to the rectal wall. The close proximity means that radiation delivered to the prostate tumor often impacts the rectum. Potential damage caused by radiation exposure to the rectum can result in bowel complications, such as diarrhea, bleeding and pain. These side effects can be temporary or last for years. There is a strong desire among patients and physicians alike to effectively treat prostate tumors while minimizing side effects.

 

What is the SpaceOAR System and how does it work?

SpaceOAR (OAR stands for “organ at risk”) System is a temporary injectable gel that protects the rectum in men undergoing radiation therapy for prostate cancer. It is the first and only prostate cancer spacing device to receive FDA clearance. No other rectum-sparing hydrogels are available in the U.S or abroad. SpaceOAR hydrogel can be used with all radiation therapy options.

The SpaceOAR System gel is injected into a patient prior to radiation therapy through a minimally invasive, outpatient procedure. The SpaceOAR hydrogel is injected through a small needle into the space between the prostate and rectum while you are put under local or general anesthesia.

Ultrasound imaging allows your doctor to see and place the hydrogel in the proper location. On average, SpaceOAR hydrogel creates about 0.5 inch (or 1.3 cm) space between the prostate and rectum, allowing your doctor to treat the prostate with much less rectum radiation injury and fewer complications. The gel remains in place for about three months during radiation treatment, and then liquefies, is absorbed and cleared from the body in your urine.

The 30-minute procedure is minimally invasive and typically performed in a hospital, surgery center or doctor’s office. Often, SpaceOAR System is inserted during the same procedure where small gold markers, called fiducials, are placed in the prostate to track its movement during radiation treatment.

 

 

What is the SpaceOAR hydrogel made of and is it safe?

SpaceOAR hydrogel is made of polyethylene glycol (PEG). PEG is widely used in cosmetics and drugs because it is nontoxic and well-tolerated by the body. In SpaceOAR hydrogel, the PEG is injected as a liquid that solidifies within seconds into a soft, gel-like synthetic material that expands and creates space between the prostate and rectum. It is called a “hydrogel” because it is mostly made up of water.

Hydrogels have been used successfully in medical treatment around the world more than 2 million times in a variety of procedures. Many studies have demonstrated that the material is biocompatible and safe to use in the body. Similar hydrogels are approved in Europe and the U.S. for use on some of the most sensitive tissues in the body. In the U.S., hydrogels are currently used in brain, spine, lung, and eye procedures.

 

Is the placement of the SpaceOAR system invasive? What can I expect to feel from the procedure?

Placement of SpaceOAR System is minimally invasive. The gel is delivered via a small needle between the prostate and rectum. You can choose to be put to sleep with sedatives during the procedure; receive local anesthesia to numb the injection area; or undergo general anesthesia.

Following the placement, some patients may experience tenderness or fullness at the injection site. These symptoms typically last for less than 24 hours.

 

What are the benefits of the SpaceOAR system?

The goal of radiation therapy is to maximize radiation to the tumor while avoiding or minimizing radiation to surrounding normal tissue. The prostate and rectum are located very close together, separated by only a small space. Due to the close proximity, the rectum can be at risk for radiation exposure during prostate cancer radiation treatment.

By separating the prostate from the rectum, SpaceOAR hydrogel reduces radiation exposure to the rectum during treatment and may reduce, or possibly eliminate, damage to the rectum and associated side effects.

In clinical trials, applying SpaceOAR System to patients reduced their rectal V70 (volume of rectum receiving 70 grays) radiation by 73%. This reduction resulted in benefits to patients including less rectal pain and a 71% reduction in long-term rectal complications.

One year following radiation treatment clinical trial patients who received SpaceOAR System were 46% less likely to experience long-term bowel quality-of-life issues, such as diarrhea, rectal urgency, and incontinence, than patients who did not receive SpaceOAR System. As a result, SpaceOAR System helped men to maintain their normal activities and lifestyle.

 

What happens to the SpaceOAR system after the completion of radiation therapy? Does it need to be removed?

After injection, SpaceOAR hydrogel remains as a soft gel separating the prostate from the rectum for about three months, during which radiation therapy is administered. After those three months, SpaceOAR hydrogel gradually begins to liquefy. Within six months, SpaceOAR hydrogel is naturally absorbed by the body and passed through urinating. Because of the SpaceOAR hydrogel’s unique ability to liquefy, no procedure is needed to remove it and patients feel nothing as the gel gradually absorbs.

 

 

When can I resume normal activities after the placement of the SpaceOAR system?

You should be able to resume day-to-day activities immediately, but be sure to check with Dr. Mehan or Dr. Wadhwa for any restrictions associated with the procedure and radiation treatment.

 

Are there any risks associated with the SpaceOAR system?

As with any medical device, there are potential risks. In addition to the risks associated with any medical procedure, there are possible complications that may be associated with the use of the SpaceOAR System that include, but are not limited to:

  • Pain from the injection
  • Pain or discomfort from the 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 or necrosis
  • Bleeding
  • Constipation
  • Rectal urgency

 

Is SpaceOAR covered by insurance?

Augmenix, the maker of SpaceOAR System, is working with the Centers for Medicare & Medicaid Services (CMS), as well as private payers, to establish insurance coverage. Payment is currently handled by physicians and patients on a case-by-case basis.

 

What is the payment system for SpaceOAR at East Valley Urology Center?

EVU Center submits claims to your health insurance provider and does its absolute best to obtain reimbursement on your behalf, should you decide to move forward with the SpaceOAR procedure. Due to the uncertainty regarding reimbursement, EVU Center must ask you to provide payment in advance of the service ($3,500).

You shouldn’t have to worry about how to get the best medical care. That’s why the office is pleased to accept the CareCredit healthcare credit card. CareCredit lets you say “yes” to recommend treatment and pay for it in convenient monthly payments that fit your budget.  Learn more by visiting Care Credit or contacting the EVU Center office.

EVU Center follows your specific insurance plan guidelines to seek reimbursement and the staff asks you for your collaboration during this process. You, as the insurance holder, has the right to appeal any denial of payment with your insurance plan directly. If partial or full reimbursement is obtained from your insurance, EVU Center refunds you the amount that your insurance covered, less co-pays and deductibles, with the refund not exceeding $3,500.

The staff at EVU Center realizes that this may feel like a big decision, but please know that the team is here to assist you along the way and answer any questions that you may have.  The medical staff is grateful you have chosen them to treat your prostate cancer and look forward to helping you get back to the life you love.