Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
Start Date
10/31/2024
Completion Date
12/31/2028
Summary
Barrigel is intended to temporarily position the anterior rectal wall away from the prostate or prostate bed during radiotherapy treatment for prostate cancer and, in creating this space, it is the intent of Barrigel to reduce the radiation dose delivered to the anterior rectum.
Detailed Description
Barrigel is composed of biodegradable material and maintains space for the entire course of prostate or prostate bed radiotherapy and is intended to be absorbed by the patient's body over time. To evaluate the safety and effectiveness of Barrigel to reduce the radiation dose delivered to the anterior rectum by creating a space when injected between the rectum and the prostate bed in men receiving definitive external beam radiation therapy (intensity-modulated radiation therapy) for recurrence of prostate cancer after radical prostatectomy. A prospective, randomized, controlled, single-masked multicenter study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Barrigel
Transrectal Ultrasound
Conditions
Locations
Arizona Clinical Trial
Chandler, Arizona 85225
United States
Sansum Clinic-Sutter Health
Santa Barbara, California 93105
United States
Baptist Health South Florida Inc
Boca Raton, Florida 33486
United States
Augusta University Research Institute
Augusta, Georgia 30912
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Summit Health
Clifton, New Jersey 07013
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Thomas Jefferson Health Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107
United States
Urology Austin
Austin, Texas 78745
United States
Houston Metro Urology
Houston, Texas 77027
United States
Virginia Urology Center
Richmond, Virginia 23235
United States
St. Vincent Hospital
Fitzroy, Victoria 3065
Australia
GenesisCare Ringwood
Melbourne, Victoria 3002
Australia