CHARDON, Ohio — Two days ago, the FDA approved a new product that protects prostate cancer patients from the side effects of radiation.
It’s called SpaceOAR (Space Organs At Risk) and it’s a hydrogel that is used as a spacer to protect the rectum, bladder and intestines in men undergoing prostate cancer (PCa) radiotherapy.
Despite many advancements in PCa radiotherapy, the close prostate-rectum proximity makes it challenging to deliver adequate radiation to the prostate without injuring the rectum (defined as the Organ At Risk – OAR). The SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for PCa, creating space to protect the anterior rectum from radiation exposure.
Dr. Rod Ellis is a radiation oncologist with University Hospitals Case Medical Center and used it today for the first time in the United States after FDA approval.
This morning at UH Geauga Medical Center Dr. Ellis implanted radioactive “seeds” inside the prostate of patient David Reeves, it’s called brachytherapy and is a common treatment for prostate cancer.
However, because the prostate gland is located close to the bladder and rectum, it is important for radiation treatment to be tightly focused on the prostate to avoid serious side effects. The SpaceOAR creates a type of pillow of space that acts as a barrier to the radiation from getting to other organs.
“For years, hydrogel products have been used safely to protect the most sensitive parts of the body as sealants and adhesion barriers, and now prostate cancer patients will also be able to benefit,” said John Pedersen, chief executive officer, Augmenix.
Placed through a small needle, the hydrogel is administered as a liquid, but quickly solidifies into a soft gel that expands the space between the prostate and rectum. The hydrogel spacer maintains this space until radiotherapy is complete. The spacer then liquefies and is absorbed and cleared from the body in the patient’s urine.
Shielding the rectum from radiation may enable the utilization of dose escalation (more prostate radiation for improved cancer kill rates) and hypofractionation (fewer radiation treatment sessions), both of which should have substantial patient benefits and help reduce healthcare costs.
According to the American Cancer Society and the National Cancer Institute, prostate cancer is second only to skin cancer as the most frequently diagnosed cancer in men with an estimated 220,800 new cases and 27,540 deaths in the U.S. in 2015 alone.
Following PCa diagnosis, treatment options are usually limited to surgery, radiotherapy or active surveillance, where no immediate treatment occurs.
This is a promising new treatment, but has so far only been tried out on a handful of patients. The reason it has received FDA approval is that the substance has been injected in other conditions and seems to be non-toxic. Whether it makes a significant difference to patient side effects has not been established, as the follow up on the few small studies that have been carried out is short. It will be interesting to see if this improves radiation treatment for prostate cancer patients