SpaceOARTM in the Central Coast of California
About 1 in 9 men will be diagnosed with prostate cancer during his lifetime, making it the second most common cancer in men behind skin cancer and second leading cause of cancer death in American men, behind lung cancer. 1 A common form of treatment for prostate cancer is radiation therapy. Although radiation therapy is effective in reducing the amount of cancerous tissue within the prostate, it can frequently cause damage to nearby organs such as the rectum. Such damage can lead to painful and embarrassing side effects.
SpaceOAR Hydrogel was created to protect these structures during radiation treatment so that patients can avoid unnecessary complications after overcoming prostate cancer. SpaceOAR Hydrogel is cleared by the FDA for use in males undergoing radiation therapy for prostate cancer and can be used with all types of radiation therapy.
How It Works
SpaceOAR Hydrogel can be placed as 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. The SpaceOAR Hydrogel is injected as liquid through a small needle inserted between the rectum and the prostate. Your doctor will use ultrasound imaging to ensure correct placement. SpaceOAR Hydrogel can be implanted under local, regional or general anesthesia. You should discuss with your doctor which type of anesthesia will work best for you.
SpaceOAR Hydrogel stays in place, separating your prostate and rectum, for about 3 months. After about 6 months, the hydrogel is naturally absorbed into the body and removed in your urine.
Results in Clinical Studies
SpaceOAR Hydrogel has been evaluated in many clinical studies and shown to be effective in reducing radiation to organs at risk. In the U.S., 222 prostate cancer patients participated in a multi-center, randomized, patient-blinded clinical study. Study results showed that the hydrogel was safe and effective. The average SpaceOAR Hydrogel study patient gained ½ inch (1.3 cm) of space between the prostate and rectum, and had significant reduction in radiation dose to the rectum resulting in significantly fewer rectal side effects. 2 Three years after treatment, patients from the study were asked to report on their quality of life for bowel, urinary and sexual functions. These patient-reported outcomes showed that SpaceOAR Hydrogel patients experienced significantly fewer long-term rectal side effects, were more likely to maintain sexual function, and showed significantly lower decline in patient reported urinary and bowel quality of life. 2,3 To read the peer-reviewed clinical studies and other publications, click here.
1. Key Statistics for Prostate Cancer. American Cancer Society. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Accessed February 20, 2020.
2. Hamstra DA, Mariados N, Sylvester J, 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):976-85.
3. Hamstra DA, Mariados N, Sylvester J, et al. Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial. Pract Radiat Oncol. 2018 Jan - Feb;8(1):e7-e15.
View important safety information here. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
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