SpaceOAR Hydrogel for Prostate Cancer Radiation Therapy – Reduces Side Effects of Bowel, Bladder and Sexual Dysfunction

SpaceOAR Hydrogel Prostate cancer treatment can vary depending on the severity, patients health and prior medical history. Radiation therapy is now an extremely precise procedure utilizing strategic techniques; however, some high doses of radiation can still cause damage to the rectal wall, contributing to adverse side effects. An innovative procedure can be done before radiation therapy to create a protective space between the posterior prostate and the rectal wall. SpaceOAR utilizes a hydrogel that creates about a 10 to 13 millimeter space (1/2 inch), allowing ample room for treatment and avoiding side effects like bowel, bladder and sexual dysfunction.

Radiation therapy typically takes place over several months, and SpaceOAR hydrogel stays in position for several months before it is safely absorbed by the body and removed through the urine. In a clinical study, SpaceOAR Hydrogel was shown to help minimize the impact on urinary, sexual and bowel quality of life for prostate cancer patients undergoing radiation therapy.1

Creating more space, means fewer bowel, bladder, and sexual complications, which leads to a better quality of life. After radiotherapy was complete, control patients experienced a clinically significant (1X MID) decline in bowel, urinary and sexual quality of life 8 times more often than SpaceOAR Hydrogel patients.1 More than 50,000 patients worldwide have been treated with SpaceOAR Hydrogel.1


Why should I have SpaceOAR Hydrogel?
By pushing the prostate farther from the rectum, the radiation dose delivered to the rectum is reduced, which may lessen damage to the rectum. With SpaceOAR Hydrogel in place, a doctor can complement the patient’s radiation treatment to better target their cancer while preserving healthy tissue to help maintain quality of life.1

Is it safe?
SpaceOAR Hydrogel was FDA-cleared in April 2015 and is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer. In creating this space, it is the intent of SpaceOAR Hydrogel to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Hydrogel is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time.1

What Is The Procedure Like And How Long Will It Stay In My Body?
SpaceOAR Hydrogel is injected as a liquid through a needle inserted between the rectum and the prostate. It can be implanted via a local anesthetic that will numb the injection area or under general anesthesia that will put a patient to sleep during the procedure. SpaceOAR Hydrogel stays in place for about three months and is naturally absorbed into the body and removed through urine in about 6 months. SpaceOAR Hydrogel can be implanted during an outpatient procedure in a hospital, surgery center, outpatient clinic or doctor’s office prior to the start of radiation treatment. It is typically not a lengthy procedure – usually about 30 minutes.1

What Are The Risks?
As with any medical treatment, there are some risks involved with the use of SpaceOAR Hydrogel. Potential complications associated with SpaceOAR Hydrogel 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.1

21st Century Oncology is the premier provider of cancer care services across multiple modalities, the largest radiation oncology provider and has one of the largest groups of urologists in the U.S. For more than 30 years, 21st Century Oncology has been committed to providing state-of-the-art, academic quality radiation therapy and other cancer treatments in a patient-centric setting focused on continuous innovation.

Headquartered in Fort Myers, Florida, the physician-centric company operates 165 treatment centers, including 129 centers located in 15 U.S. states. The Company also operates 36 centers located in eight countries in Latin America.

21st Century Oncology employs or is affiliated with nearly 1,000 physicians globally, including:
• Breast Surgeons
• Colorectal Surgeons
• Ear, Nose and Throat Specialists
• General Surgeons
• Gynecologic Oncologists
• Head and Neck Surgeons
• Medical Oncologists
• Pathologists
• Pulmonologists
• Radiation Oncologists
• Radiologists
• Surgical Oncologists
• Urologists

21 Century Oncology works together to deliver the most advanced integrated cancer care.

Florida Urology Specialists
1 S. School Avenue, Suite 200 • Sarasota, FL 34237
941.309.7000 • Fax1 941.308.8508



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