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Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Male
Things to know
Study dates
Study start: 2024-08-05
Primary completion: 2027-12-01
Study completion finish: 2027-12-31
Study type
PREVENTION
Phase
NA
Trial ID
NCT06496256
Intervention or treatment
DEVICE: Barrigel
DEVICE: Transrectal Ultrasound
Conditions
- • Prostate Cancer
Find a site
Closest Location:
GenesisCare Ringwood
Research sites nearby
Select from list below to view details:
GenesisCare Ringwood
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Treatment Arms
| DEVICE: Barrigel
|
SHAM_COMPARATOR: Control Arm
| DEVICE: Transrectal Ultrasound
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Reduction 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. | 3 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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. | 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 | 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 | 3 months |
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