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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
84
Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space
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
Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGSummit Health
Clifton, New Jersey, United States
RECRUITINGUrology Austin
Austin, Texas, United States
RECRUITINGReduction in volume of rectum receiving radiation dose
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.
Time frame: 3 months
Grade 2 Toxicities
Test whether the use of the Barrigel spacer does not increase the incidence of acute grade 2+ GI toxicity within the first 3 months, which will be assessed using the proportion of subjects who have one or more incidences of acute grade 2+ GI toxicity within the first 3 months.
Time frame: 3 Months
Expanded Prostate Cancer Index Composite (EPIC) bowel QOL
Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment composite score (from baseline within 3 months after completion of radiation therapy. The EPIC is graded on a 12 point scale, with a higher score indicating a higher outcome.
Time frame: 3 months
Expanded Prostate Cancer Index Composite (EPIC) Urinary QOL
Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Urinary Assessment composite score from baseline within 3 months after completion of radiation therapy. The EPIC is graded on a 12 point scale, with a higher score indicating a higher outcome.
Time frame: 3 months
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Houston Metro Urology
Houston, Texas, United States
ACTIVE_NOT_RECRUITINGGenesisCare Ringwood
Melbourne, Victoria, Australia
RECRUITING