Barrigel PPRT: Investigating how well a gel can protect the rectum during radiation treatment for prostate cancerRandomized Trial of Barrigel® to Increase Distance Between the Rectum and Prostate Bed to Decrease Rectal Dose in Patients Receiving Moderately Hypofractionated Radiation Therapy Who Have Had Recurrence of Prostate Cancer After Prostatectomy

Trial purpose

Cancer treatment; Side effect and wellbeing

Tumor type

Genitourinary

Age

18+

Trial acronym

Barrigel PPRT

Summary

Barrigel is a gel that is placed between the prostate area and the rectum during radiation treatment for prostate cancer. Its purpose is to gently push the rectum away from the prostate so that the rectum receives less radiation.

Barrigel is made of biodegradable material. It keeps the space in place for the whole course of radiation treatment and is absorbed by the body over time.

This study will look at how safe and effective Barrigel is at protecting the rectum by creating this space during external beam radiation therapy (intensity-modulated radiation therapy) for people whose prostate cancer has returned after surgery.

Eligible participants will be randomly allocated to one of two arms - whether to receive Barrigel or not:

• Experimental Arm: Participants will receive a Barrigel injection between the rectum and prostate bed using transrectal ultrasound for guidance.
• Control Arm: Participants will not receive Barrigel but will have a transrectal ultrasound probe inserted to simulate that aspect of the injection of Barrigel.

All participants will continue receiving definitive external beam radiation therapy.

Conditions

This trial is treating people with prostate cancer who have bene primarily treated with a radical prostatectomy and who intend to receive definitive radiation therapy to the prostate bed