Study of Barrigel Device to Protect the Rectum During Radiation After Prostate Surgery for Recurrent Prostate Cancer

What this Trial Is About

Researchers are evaluating Barrigel, a biodegradable gel designed to create space between the anterior rectal wall and the prostate or prostate bed during radiotherapy for prostate cancer patients who have had a prostatectomy and now face cancer recurrence. The goal is to reduce radiation exposure to the rectum by positioning it away from the radiation target area. This prospective, randomized, controlled, single-masked multicenter study focuses on men receiving intensity-modulated external beam radiation therapy for this condition. Participants will be randomly assigned to one of two groups. One group will receive an injection of Barrigel between the rectum and prostate bed guided by transrectal ultrasound, while the control group will undergo a sham procedure involving insertion of a transrectal ultrasound probe without Barrigel injection. Barrigel is made of absorbable material and maintains the created space throughout the radiation therapy course before gradually being absorbed by the body. During the study, participants will undergo assessments including imaging and quality of life questionnaires at set intervals, particularly three months after treatment. Researchers will measure the reduction in the volume of rectum exposed to radiation, monitor grade 2 toxicities, and evaluate bowel and urinary quality of life using the Expanded Prostate Cancer Index Composite. Safety and adherence to the study protocol will be closely monitored throughout the treatment and follow-up periods.

Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial