Barrigel® for Reducing Rectal Radiation in Prostate Cancer Recurrence
This study aims to assess whether Barrigel can effectively reduce the amount of radiation received by the rectum in men undergoing treatment for recurring prostate cancer.
Barrigel
+ Transrectal Ultrasound
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Prevention Study
Summary
Study start date: October 31, 2024
Actual date on which the first participant was enrolled.This clinical trial is designed to evaluate a product called Barrigel, which is made from a biodegradable material. The main goal is to determine if Barrigel can safely and effectively reduce the amount of radiation that reaches the rectum in men who are undergoing radiation therapy for prostate cancer that has returned after surgery. By creating more space between the rectum and the area where the prostate used to be, it is hoped that Barrigel can help protect the rectum from radiation damage, potentially leading to fewer side effects and better outcomes for patients. Participants in the study will receive injections of Barrigel to create a space between the rectum and the prostate bed before they begin their radiation treatment. The study involves multiple centers and is designed so neither the participants nor those assessing the outcomes know who receives the Barrigel injection. The study will look at whether this method effectively reduces radiation exposure to the rectum, while also monitoring for any safety concerns. The ultimate aim is to see if using Barrigel can provide a safer radiation therapy experience for patients with recurrent prostate cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.84 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Summit Health
Clifton, United StatesUrology Austin
Austin, United StatesGenesisCare Ringwood
Melbourne, Australia