Barrigel is a hyaluronic acid rectal spacer indicated for patients with T1 to T3b prostate cancer disease.
Barrigel was effective in reducing radiation exposure to the rectum by separating the rectum from the prostate during radiation therapy for prostate cancer, according to results from the Barrigel Pivotal Trial published in JAMA Oncology.1
“Palette Life Sciences is extremely proud of our safety and efficacy data being published in JAMA Oncology and is proud to advance better health outcomes for the approximately 290,000 men in the United States who are diagnosed with prostate cancer each year. Radiation therapy is becoming the gold standard for prostate cancer treatment, and this study shows that Barrigel is proven safe and effective at achieving a clinically significant reduction in radiation dose to the rectum, leading to fewer rectal side effects,” Per G. Langö, chief executive officer and board director of Palette Life Sciences, the developer of the spacer, stated in a news release.2
Barrigel is a hyaluronic acid rectal spacer indicated for patients with T1 to T3b prostate cancer disease. The spacer recently received 510(k) clearance by the FDA and has been approved for rectal spacing in Australia and Europe. It is currently being developed for market introduction in Japan.
The Barrigel randomized clinical trial included 201 adult patients across 12 centers in the United States, Australia, and Spain. Participants had biopsy-proven T1 to T2 prostate cancer disease with a Gleason score of 7 or less. All patients underwent hypofractionated radiation therapy, with 136 patients undergoing treatment with the presence of the spacer and 65 patients undergoing therapy without it.
The primary efficacy end point was the percentage of patients who achieved at least a 25% reduction in radiation dose to the rectum. The secondary end point was the percentage of patients who experienced grade 2+ gastrointestinal (GI) toxic effects, as classified by the Common Terminology Criteria for Adverse Events, within the first 3 months.
The investigators found that Barrigel was effective at achieving a clinically significant reduction of radiation dosage to the rectum as well as in reducing adverse events.
“In the study, 98.5% of patients who were treated with Barrigel met the primary end point of achieving at least a 25% reduction in radiation dose to the rectum, leading to fewer side effects. Patients who met the primary end point averaged an 85% reduction in radiation to the rectum. Additionally, Barrigel was proven superior in the reduction of acute grade ≥2 GI toxicity compared [with] the control cohort, and there were zero Barrigel-related adverse events reported,” lead author Neil Mariados, MD, stated in the news release. Mariados is a radiation oncologist at Cancer Care of Western New York.
Acute grade 2 or higher GI toxic effects were observed in 2.9% of patients in the spacer group compared with 13.8% of patients in the control group (P = .01). Patients in the trial will continue follow-up for 3 years.
1. Mariados NF, Orio III PF, Schiffman Z, et al. Hyaluronic acid spacer for hypofractionated prostate radiation therapy: a randomized clinical trial. JAMA Oncology. 2023 Feb 9;e227592. doi: 10.1001/jamaoncol.2022.7592.
2. Palette Life Sciences announces publication of Barrigel pivotal safety and efficacy clinical trial data in JAMA Oncology. News release. Palette Life Sciences. Published online February 9, 2023. Accessed February 13, 2023.https://www.palettelifesciences.com/news/palette-life-sciences-announces-publication-of-barrigel-pivotal-safety-and-efficacy-clinical-trial-data-in-jama-oncology/