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Jupiter Medical Center (JMC) Prostate Cancer Discussion: Treatment, Progress, Side Effects, and SpaceOAR Hydrogel

When it comes to radiation therapy and prostate cancer, SpaceOAR Hydrogel can help minimize side effects and time spent in the clinic

For much of its history, radiation therapy for cancer has involved dosing the region of a patient’s body surrounding a tumor with high doses of radiation. This has tended to increase recovery time and diminish quality of life for the patient, both during and following treatment. There are now far more intricate techniques available that enable a radiation oncologist to pinpoint beams of radiation, with sub-millimeter accuracy, to the core of a tumor, allowing more of the surrounding healthy organs to be spared. While these novel regimens have reduced the typical side effects of radiation, they have not eliminated them entirely. For prostate cancer, in particular, there are still considerable challenges. Nathan Tennyson, MD, and Raj Rajpara, MD, radiation oncologists at Jupiter Medical Center (JMC), discuss with Pinnacle Magazine how prostate cancer is being treated, and how progress is being made in addressing the side effects through the use of a new hydrogel product.

Can you discuss the prevalence of prostate cancer and its survival rates?
Rajpara: It still is the most common cancer diagnosis in men in the United States. About 1 in 9 men are diagnosed with prostate cancer at some point in their lives.* We have new, sophisticated ways we can treat it, and with the appropriate treatment, survival is improving. More and more patients are being cured and prostate cancer–specific mortality is decreasing with appropriate treatment. Bowel toxicity is a major factor in radiotherapy for prostate cancer.

*As of 2022, the American Cancer Society estimates about 1 in 8 men will be diagnosed with prostate cancer in his lifetime.(1)

Can you talk about how and why rectal toxicity occurs, and what some of the symptoms are?
Tennyson: For men who undergo prostate radiotherapy, there’s always a portion of the rectum that’s exposed to radiation therapy—because the rectum is very close to the prostate itself, and some of it, unfortunately, is included in the radiation therapy field. It’s unavoidable, and that’s really what causes the side effects. Those symptoms typically include bowel urgency and diarrhea. These are the acute side effects, meaning they occur during the treatment. There are also potential long-term side effects, including rectal bleeding, which used to be more common before technology got better but still can happen today. There are some very fragile blood vessels in the radiation field, and those can bleed years after the radiation is done. SpaceOAR Hydrogel can alleviate a lot of the side effects involving rectal toxicity.2,3

Can you discuss the SpaceOAR Hydrogel procedure and what it accomplishes?
Rajpara: SpaceOAR Hydrogel is an outpatient procedure that takes about 10 to 15 minutes. We do it at the same time as fiducial marker placement, which is used to help target and track the prostate during radiation treatment. We inject the gel in the space between the prostate and the rectum using an ultrasound for guidance. Patients go home the same day. The gel solidifies once it’s in the body and stays in the body for about three to six months. [While it’s in], it increases the space between the prostate and the rectum by about 1 to 2 centimeters. With radiation, even a few millimeters are a big deal because of the way the radiation beams are designed. A few millimeters of space can dramatically decrease the dose going to the rectum, so you can imagine 2 centimeters—that’s a lot of space. So, what that does is it helps prevent those rectal side effects during radiation, but more importantly, also those long-term side effects. The studies show that the gel also improves quality of life in terms of sexual dysfunction and urinary symptoms.2-4

Because of the insulation provided by the SpaceOAR Hydrogel, are you able to give a larger single dose?
Tennyson: Yes and no. There are three courses of radiation: a nine-week, 44-treatment course; a middle-of-the-road, 28-treatment course; and then a five-treatment, Cyberknife-based radiation treatment. For those patients getting the shorter courses, the dose of radiation is larger, so we do recommend SpaceOAR Hydrogel a bit more for those patients, because I am concerned about the rectal toxicity in that group. It’s made me more willing to do the shorter courses because I know the rectum will be protected.

SpaceOAR Hydrogel has been in use for about a year at JMC. Are other medical centers, locally or regionally, using it as well?
Rajpara: There are a few other centers in Palm Beach County that are doing it, but in terms of major hospitals that are performing it, no, I can’t think of any. We’ve had a lot of patients that come to our offices just because we offer it and other centers do not.

Is there anything that’s come up in the last year that you’d like to add?
Tennyson: For patients with prostate cancer, we want to minimize the side effects. We want to minimize the time that the patients are here, because they’d rather be doing other things, and SpaceOAR Hydrogel is one more tool available to us to do that.

References:

1. Key Statistics for Prostate Cancer. American Cancer Society. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Accessed December 19, 2022.
2. Mariados N, Sylvester J, Shah D, et al. Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2015;92(5):971-977.
3. 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;97(5):976-985.
4. Data on File with Boston Scientific.

Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary. BSC strongly recommends that you consult with your physician on all matters pertaining to your health or to address any questions.

SpaceOAR Hydrogel is intended to temporarily move the rectal wall away from the prostate during the course of radiotherapy treatment for prostate cancer, and in creating this space it is the intent of SpaceOAR Hydrogel to reduce the radiation dose affecting the rectum. 

SpaceOAR Hydrogel contains polyethylene glycol (PEG). 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 injection, pain or discomfort from the  hydrogel, site inflammation, infection (including abscess), inability to urinate, urgent need to urinate, constipation, rectal muscle spasm, damage to lining of rectum, ulcers, fistula (a hole between rectum and bladder, urethra, or skin below the scrotum), perforation (hole in prostate, bladder, urethra, rectum), necrosis (dead tissue), allergic reaction (local reaction or more severe reaction, such as anaphylaxis), embolism (blood vessel blockage is possible and may happen outside of the pelvis, potentially impacting vital organs or legs), fainting, and bleeding. Please talk to your doctor about the risks and benefits related to using SpaceOAR Hydrogel. If one or more of these complications occur, you may need medical treatment or surgery. URO-1288805-AA 

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.

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