Barrigel® for Radiation Therapy After Prostatectomy
This study is testing Barrigel, an absorbable gel, to see if it can protect the rectum during radiation therapy for prostate cancer. If you're a man aged 18 or older who has had a radical prostatectomy (surgery to remove the prostate) for prostate cancer, you might be able to join. The study aims to reduce the amount of radiation the rectum receives by creating a space between the rectum and the prostate area. Researchers will measure this reduction after 3 months. The study is currently recruiting 84 participants, but its overall status is unclear.
- Study design
- This is a prospective, randomized, controlled, single-masked multicenter study involving 84 participants. Some participants will receive Barrigel, while others will have a sham procedure.
- What's involved
- You will undergo a transrectal ultrasound (TRUS) procedure. If you receive Barrigel, the TRUS will guide its placement.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, reduction in rectal radiation dose, is measured at 3 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
At a glance
Conditions
Where it's being run
5 sites across 4 statesWho to contact
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What this trial measures
- Reduction in volume of rectum receiving radiation dose3 months
Investigational subjects only: Achievement of a ≥ 25% change in reduction in the volume of rectum receiving 90% of the prescription dose in 70% of the subjects.