First Patient Enrolled in Teleflex’s Barrigel™ Rectal Spacer PPRT Trial

Teleflex Incorporated has recently launched a clinical study focusing on the use of the Barrigel™ rectal spacer in patients who have experienced a recurrence of prostate cancer post-prostatectomy. This randomized, controlled, single-blind multicenter study, known as the PPRT Trial, marks a significant step in personalized spacing evidence. By exploring the efficacy of Barrigel™ in hypofractionated post-prostatectomy radiation therapy, the study aims to expand the clinical evidence supporting its use.

Barrigel™ rectal spacer is a unique, sculptable hyaluronic acid product designed to minimize radiation exposure to the rectum during prostate radiation therapy. Unlike other rectal spacers that harden almost immediately, Barrigel™ remains soft and pliable, allowing physicians the flexibility to sculpt and adjust it for optimal rectal protection. This quality significantly aids in hypofractionated treatment regimens, where higher radiation doses are administered over fewer sessions.

The study began with the enrollment of the first patient, a milestone acknowledged by Dr. Martin T. King, a Radiation Oncologist at the Dana-Farber Brigham Cancer Center and an Assistant Professor at Harvard Medical School. Dr. King, the principal investigator of the study, emphasized that their goal is to demonstrate the safety and effectiveness of Barrigel™ in reducing radiation side effects for prostate cancer patients undergoing post-prostatectomy radiation therapy.

Prostate cancer recurrence rates post-radical prostatectomy can range from 16 to 46 percent, highlighting the need for effective radiation treatments that minimize collateral damage to healthy tissues. Rectal spacers like Barrigel™ play a crucial role in this regard by allowing a higher radiation dose to be focused on the prostate while protecting the rectum.

The trial will enroll patients who have undergone nerve-sparing prostatectomy and show no radiographic evidence of local, regional, or distant metastatic disease as confirmed by PSMA PET imaging. Additionally, candidates must have an intact fascial layer to support the spacer and have completed six months of androgen deprivation therapy, which is the first-line treatment for advanced prostate cancer.

Radiation Oncologist Dr. Michael Chao, from the Olivia Newton John Cancer Wellness & Research Centre in Victoria, Australia, expressed his pride in being the first physician to treat a patient in this trial. He reiterated the importance of scientific evidence in advancing medical technologies and building trust between clinicians and patients.

Barrigel™ rectal spacer, made from Non-Animal Stabilized Hyaluronic Acid (NASHA), is highly biocompatible and fully absorbable, with a strong track record of safety and efficacy in various medical applications worldwide. The product has been shown to significantly reduce the adverse side effects associated with prostate cancer radiation therapy and is approved for use in the United States, Australia, and Europe. It is suitable for prostate cancer patients with T1-T3b disease.

In summary, the Barrigel™ rectal spacer represents a pioneering approach in prostate cancer radiation therapy, offering a promising solution to minimize radiation-related side effects while allowing for effective treatment of recurrent prostate cancer post-prostatectomy. The ongoing PPRT Trial is expected to further solidify its role in enhancing patient outcomes and advancing prostate cancer care.