North Florida Regional Medical Center Announces Use of SpaceOAR® Hydrogel

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North Florida Regional Medical Center announces that they are the first and only appliers of SpaceOAR hydrogel in Gainesville, Florida.

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North Florida Regional Medical Center announces that they are the first and only appliers of SpaceOAR hydrogel in Gainesville, Florida. SpaceOAR hydrogel is used for prostate cancer radiotherapy and acts as a protective spacer between the prostate and the rectum and has been clinically proven to reduce the risk of side effects during and after radiation treatment.

North Florida Regional Healthcare is dedicated to the care of patients with cancer at The Cancer Center, a 25,000 square-foot, state –of-the-art facility. Treatment modalities at the center include Radiation Oncology, Intensity-Modulated Radiation Therapy, Image Guided Radiation Therapy, High Dose and Low Dose Rate Brachytherapy and Stereotactic Radiosurgery with the CyberKnife. The American College of Surgeons Commission designates the program as a Community Hospital Comprehensive Cancer Program. Their multidisciplinary oncology team is dedicated to cancer prevention, early detection, timely diagnosis, optimal treatment, rehabilitation and support. North Florida Regional embraces clinical research, new technologies and therapeutic advancements in the fight against cancer.

“We are excited to bring forth a spacer application to our patients in Gainesville and surrounding communities that not only allows for reduced rectal side effects and toxicity but has been shown to improve patient reported sexual quality of life with radiation treatment for prostate cancer,” said Dr. Cherylle Hayes, Radiation Oncologist. “This is a game changer when it comes to treatment options for our patients.”

In April 2015, the Food and Drug Administration (FDA) cleared SpaceOAR hydrogel. In a prospective, randomized, multi-center clinical trial in the United States, patients treated with SpaceOAR hydrogel prior to prostate cancer radiation treatment demonstrated bowel, urinary, and sexual benefits through three years of follow-up. The study found that the patients that did not receive SpaceOAR hydrogel experienced a clinically significant decline in bowel, urinary, and sexual quality of life eight times more often than patients that received SpaceOAR hydrogel. It is a minimally invasive outpatient procedure with local or general anesthesia. Patients can immediately resume their normal activities. The gel stays in place for approximately three months and is then naturally absorbed and cleared in the urine in about six months. (1,2)

“Treatment of prostate cancer with radiotherapy has often been limited by the toxicity to adjacent organs, such as the rectum, bladder, and penile bulb,” said Dr. Charles (Trey) Perkins, Radiation Oncologist. “SpaceOAR really is the latest advancement in minimizing those immediate and permanent side effects, taking us to the next level in prostate cancer treatment. Its benefits with respect to long-term quality of life and men’s health cannot be overstated.”

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North Florida Radiation Oncology is an ACR accredited center.

1) DA Hamstra, N Mariados, J Sylvester, et al. Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys; 2017 Apr 1; 97(5): 976-985

2) DA Hamstra, et al. Sexual Quality of Life Following Prostate Intensity Modulated Radiotherapy (IMRT) with a Rectal/Prostate Spacer: Secondary Analysis of a Phase III Trial. Published online: July 19, 2017 Practical Radiation Oncology.

SpaceOAR is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and 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. It is completely absorbed by the patient’s body over time. Clinical data comparing patients with and without SpaceOAR hydrogel demonstrated the benefits of SpaceOAR hydrogel to include reduction of rectal toxicity resulting in improved bowel function, improvements in urinary function, and a higher likelihood to maintain sexual function. 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.

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April Renzella

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