Long-Term Data Further Confirm SpaceOAR Hydrogel Quality-of-Life Benefits

Long-Term Data Further Confirm SpaceOAR Hydrogel Quality-of-Life Benefits

Prostate cancer patients who received the SpaceOAR hydrogel before radiation therapy continue to report benefits five years after treatment, including better urinary and sexual function, a new study reported.

The study titled, “Quality of Life After Radiation Therapy for Prostate Cancer With a Hydrogel Spacer: 5-Year Results,” was published in the International Journal of Radiation Oncology: Biology, Physics.

“These long-term results further validate previous 3-year data of the SpaceOAR System and highlight the long-term bowel and sexual Quality of Life benefits it can provide to prostate cancer patients who are treated with radiotherapy,” Michael Pinkawa, MD, PhD, radiation oncologist at MediClin Robert Janker Klinik in Bonn, Germany, and lead author of the study, said in a press release.

The SpaceOAR system, developed by Augmenix, was designed to temporarily create a protective space between the prostate and the rectum wall. By pushing the tissues apart, the injectable solution reduces the amount of radiation that reaches the rectum, minimizing its potentially damaging effects. The spacer is stable for three months, after which it returns to liquid form and is absorbed by the body.

Recently, data from a three-year follow-up of a pivotal Phase 3 trial (NCT01538628) showed that patients who used the SpaceOAR system had decreased rectal toxicity and fewer declines in both urinary and bowel quality of life compared with the control group.

Now, researchers at the RWTH Aachen University Department of Radiation Oncology, in Germany, evaluated the quality of life changes up to five years after prostate cancer radiation therapy.

The study included 114 patients, 54 of whom received the hydrogel prior to prostate cancer radiotherapy. Participants were surveyed for quality of life measures at baseline, at the last day of radiation therapy, and at two, 17, and 63 months after radiation therapy.

One and a half years after receiving radiation therapy, more patients in the control group (32%) reported bothersome bowel symptoms than in the hydrogel group (6%).

The benefits were sustained for over five years, with only 5% of the hydrogel-treated patients reporting bothersome bowel symptoms compared with 14% in the control group.

Moderate to large problems with bowel urgency were also less frequent in the SpaceOAR group at both 1.5 years (0% vs. 13%) and five years (0% vs. 14%).

During the study, five patients in the control group required invasive bowel procedures to manage adverse bowel symptoms. Only one patient treated with SpaceOAR required such procedures.

The SpaceOAR system also was associated with better sexual function five years after radiation therapy. Patients treated with SpaceOAR were eight times more likely to have an erection sufficient for intercourse compared with those in the control group.

“This 5-year data confirms previously reported 3-year outcomes from our randomized, multi-center trial and continues to build a growing portfolio of studies supporting the use of SpaceOAR hydrogel spacing during radiotherapy for prostate cancer,” said John Pedersen, CEO of Augmenix.

“We remain committed to furthering the spacing concept that we believe will help many patients return to and maintain pre-treatment quality of life following prostate radiotherapy,” he added.

The U.S. Food and Drug Administration (FDA) approved SpaceOAR System in April 2015, and SpaceOAR currently is used in many of the leading clinical centers in the United States.

One comment

  1. Stephen B. Strum, MD, FACP says:

    What I have noted in following patients who have received IMRT as definitive treatment for PC is that despite IMRT being an advance over conventional RT, and perhaps 3D conformal radiation therapy (3DCRT) in general, there are too many men who become hypogonadal in the years following RT. The ↑ occurrence of bladder cancer also speaks to the radiation scatter (most likely) to adjacent tissues (e.g., bladder, rectal wall, gonads, penile bulb). What would be important to check with these authors & others using SpaceOAR is whether baseline free & total testosterone were obtained and follow-up studies as well as the same for LH and FSH.
    I will have to read the full article to understand the composition of SpaceOAR. Perhaps a similar concept should be employed to ↓ rectal toxicity from men undergoing cryotherapy for PC. I am also assuming that men undergoing brachytherapy might also be studied.

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