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Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
Sponsor: Palette Life Sciences, Inc.
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.
Official title: Randomized 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
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2024-10-31
Completion Date
2028-12-31
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
Barrigel
Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space
Transrectal Ultrasound
All subjects will have a transrectal ultrasound (TRUS) conducted. In the control subjects this will act as a sham procedure. For the investigational subjects, the TRUS will be used to visualize the placement of the needle
Locations (13)
Arizona Clinical Trial
Chandler, Arizona, United States
Sansum Clinic-Sutter Health
Santa Barbara, California, United States
Baptist Health South Florida Inc
Boca Raton, Florida, United States
Augusta University Research Institute
Augusta, Georgia, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Summit Health
Clifton, New Jersey, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Thomas Jefferson Health Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Urology Austin
Austin, Texas, United States
Houston Metro Urology
Houston, Texas, United States
Virginia Urology Center
Richmond, Virginia, United States
St. Vincent Hospital
Fitzroy, Victoria, Australia
GenesisCare Ringwood
Melbourne, Victoria, Australia