BioDFence G3 for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests BioDFence G3, a treatment used during robotic prostate surgery, to determine if it improves recovery. It focuses on men with early-stage prostate cancer scheduled for nerve-sparing surgery. Men with untreated prostate cancer who require surgery might be suitable candidates. The trial aims to assess patients' functional recovery after surgery with this treatment. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immuno-suppressants, chemotherapy, or hormonal therapy, you may not be eligible to participate.
Is there any evidence suggesting that BioDFence G3 is likely to be safe for humans?
Research has shown that BioDFence G3 has undergone testing in people. This protective covering, used during surgeries, is made from placental tissue and is usually well-tolerated by the body. Previous studies demonstrated that it safely aids in tissue healing. The product adheres to strict FDA regulations, ensuring it meets safety standards.
Treatments at this research stage have generally shown promising safety in earlier trials. This suggests that BioDFence G3 is likely safe for use in surgeries similar to the one under study.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for post-prostatectomy care, which often involve medications or physical therapy to aid nerve recovery and reduce complications, BioDFence G3 is a novel approach that involves placing a sheet directly on the neurovascular bundle during surgery. This unique delivery method provides a physical barrier that may help protect and support nerve healing right at the site. Researchers are excited because this could enhance nerve preservation and improve recovery outcomes, potentially leading to better urinary and sexual function post-surgery.
What evidence suggests that BioDFence G3 is effective for improving functional outcomes after robotic radical prostatectomy?
Research shows that BioDFence G3 uses materials from the placenta to create a supportive environment for healing. These materials act as a framework that aids tissue repair. This support proves especially helpful after surgeries like robotic-assisted radical prostatectomy, where precise healing is crucial. BioDFence G3 consists of a special membrane that doctors can easily handle during surgery. In animal studies, similar membranes from the amniotic sac showed promise in aiding recovery and reducing inflammation. This evidence suggests that BioDFence G3 could effectively improve healing after prostate surgery.16789
Who Is on the Research Team?
Vipul R Patel, MD
Principal Investigator
AdventHealth
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
BioDFence® G3 is placed on the neurovascular bundles during robotic-assisted radical prostatectomy
Follow-up
Participants are monitored for functional outcomes post-operatively, including potency and continence
What Are the Treatments Tested in This Trial?
Interventions
- BioDFence G3
Find a Clinic Near You
Who Is Running the Clinical Trial?
AdventHealth
Lead Sponsor
Integra LifeSciences Corporation
Industry Sponsor
Mojdeh Poul
Integra LifeSciences Corporation
Chief Executive Officer
Bachelor’s and Master’s degrees in Mechanical Engineering from the University of Louisville, MBA from the University of North Carolina at Chapel Hill
Dr. Lisa Egbuonu-Davis
Integra LifeSciences Corporation
Chief Medical Officer since 2023
MD from Harvard Medical School