Trial launches of Barrigel rectal spacer for post-prostatectomy radiation therapy

The first patient has been enrolled and treated in the PPRT trial (NCT06496256), which is assessing the safety and effectiveness of Barrigel rectal spacer for patients who are undergoing hypofractionated post-prostatectomy radiation therapy for prostate cancer.¹

Final completion of the PPRT trial is expected in December 2027.

Barrigel is a hyaluronic acid rectal spacer designed to separate the rectum from the prostate to protect the rectum during radiation treatment. The spacer was granted 510(k) clearance by the FDA in June 2022 for use during radiation treatment in patients with T1-T3b prostate cancer.² The spacer is also approved in Australia and Europe.

According to Teleflex, the developer of the spacer, the PPRT trial will be the first to include patients who experienced prostate cancer recurrence following radical prostatectomy.

“Our first enrolled patient represents a significant milestone as we grow our body of clinical evidence for Barrigel rectal spacer with patients undergoing radiation therapy after a prior prostatectomy,” said principal investigator Martin T. King, MD, PhD, a radiation oncologist with the Dana-Farber Brigham Cancer Center and an assistant professor of radiation oncology at Harvard Medical School in Boston, Massachusetts, in the news release.¹ “Our study end points are to demonstrate Barrigel rectal spacer as a safe and effective option that reduces prostate radiation side effects for this patient population.”

The first patient in the trial was treated by Michael Chao, MD, who is a radiation oncologist at the Olivia Newton John Cancer Wellness & Research Centre in Victoria, Australia.

“Scientific evidence serves as the cornerstone for the advancement and expansion of medical technologies, fostering trust between clinicians and patients,” said Chao in the news release.¹ “I take great pride in being the first physician to treat a patient in this clinical trial.”

In total, the prospective, single-blinded, multicenter study plans to enroll 84 adult patients across clinical trial sites in the United States and Australia.³

Patients are eligible for enrollment in the study if they have undergone nerve-sparing prostatectomy (intrafascial); have no radiographic evidence of local regional, or distant metastatic disease per PSMA-PET imaging; have an intact facial layer to support the rectal spacer; and underwent 6 months of androgen deprivation therapy. Participants must also have an ECOG performance score of 0 or 1 and a prostate-specific antigen level of 0.1 ng/mL or higher.

For the study, eligible participants will be randomly assigned to receive transrectal ultrasound (TRUS) with or without an injection of Barrigel prior to undergoing radiation therapy. In the patients that do not receive Barrigel, TRUS will act as a sham procedure.

The primary outcome measure for the study is a reduction in the volume of the rectum receiving the radiation dose, assessed at 3 months. Specifically, the investigators will evaluate the achievement of at least a 25% reduction in the volume of rectum receiving 90% of the prescription radiation dose in 70% of the participants.

Secondary outcome measures include grade 2 toxicities and urinary and bowel quality of life measures.

Final completion of the study is expected in December 2027.

References

1. First patient enrolled in Teleflex’s Barrigel rectal spacer trial for post radical prostatectomy radiation therapy (PPRT). News release. Teleflex Incorporated. October 29, 2024. Accessed November 5, 2024. https://www.biospace.com/press-releases/first-patient-enrolled-in-teleflexs-barrigel-rectal-spacer-trial-for-post-radical-prostatectomy-radiation-therapy-pprt

2. Palette Life Sciences announces FDA 510(k) clearance for Barrigel rectal spacer, proven safe and effective at minimizing the harmful long-term side effects of prostate radiation therapy. News release. Palette Life Sciences. June 9, 2022. Accessed November 5, 2024. https://www.biospace.com/palette-life-sciences-announces-fda-510-k-clearance-for-barrigel-rectal-spacer-proven-safe-and-effective-at-minimizing-the-harmful-long-term-side-effects-of-prostate-radiation-therapy

3. Barrigel PPRT (Post-Prostatectomy Radiation Therapy) trial. ClinicalTrials.gov. Last updated July 12, 2024. Accessed November 5, 2024. https://clinicaltrials.gov/study/NCT06496256