BioDFence G3 for Prostate Cancer

Overseen By Tadzia Harvey, RN,BSA

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: AdventHealth

Must be taking: 5-phosphodiesterase inhibitors

Must not be taking: Immuno-suppressants, Cytotoxic chemotherapy

Disqualifiers: Diabetes, Atherosclerosis, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

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. ^{1 2 3 4 5}

Why 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. ^{1 6 7 8 9}

Who Is on the Research Team?

Vipul R Patel, MD

Principal Investigator

AdventHealth

Are You a Good Fit for This Trial?

Inclusion Criteria

Primary diagnosis of prostate cancer requiring surgical intervention

Have a willingness to comply with follow-up requirements.

Male subjects between the ages 40-70.

Exclusion Criteria

Has signs or symptoms of any other disease which could result in allograft failure or has experienced graft failure in the past.

Has a documented medical history of drug or alcohol abuse within last 12 months.

Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

BioDFence® G3 is placed on the neurovascular bundles during robotic-assisted radical prostatectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for functional outcomes post-operatively, including potency and continence

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• BioDFence G3

How Is the Trial Designed?

Group I: Single Arm Study Group Experimental Treatment 1 Intervention

Placement of a sheet of BioDFence G3 to the neurovascular bundle.

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Integra LifeSciences Corporation

Industry Sponsor

Trials

110

Recruited

11,300+

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

Citations

1.

trial.medpath.com

trial.medpath.com/clinical-trial/44923de96b8f372f/nct05363644-treatment-protocol-biodefence-g3-robotic-prostatectomy

BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted ...

The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10376312/

Placental-Derived Biomaterials and Their Application to ...

Research has shown that placental-derived biomaterials can be used to promote wound healing by providing an ECM scaffold for tissue repair.

3.

products.integralife.com

products.integralife.com/biodfence-g3-placental-tissue-membrane/product/surgical-reconstruction-surgical-amniotics-biodfence-g3-placental-tissue-membrane

BioDFence® G3 Placental Tissue Membrane

BioDFence G3 Placental Tissue Membrane is a dehydrated, tri-layer amnion-chorion-amnion allograft providing enhanced handling characteristics.

4.

encompassbiologics.com

encompassbiologics.com/wp-content/uploads/2020/11/Madigan_DrKuckelman_Human_Derived_Amniotic_Membrane_Is_Associated_With.14.pdf

Human-Derived Amniotic Membrane Is Associated With ...

Animals were randomly assigned to 1 of 5 groups: sham, control, saline, hyaluronic acid membrane, or amniotic membrane. Animals were euthanized at 14 days. MAIN ...

5.

ctv.veeva.com

ctv.veeva.com/study/biodfence-r-g3-for-full-nerve-sparing-robotic-assisted-radical-prostatectomy

BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted ...

The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.

6.

products.integralife.com

products.integralife.com/file/products/biodfence-g3-placental-tissue-membrane-rev-d-usa.pdf

BioDFence® G3

All tissue has been collected, processed, stored, and distributed in compliance with the FDA regulations governing HCT/Ps. Although every effort has been made ...

7.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK554211/table/appd.tab2/

Skin Substitutes for Treating Chronic Wounds - NCBI Bookshelf

BioDFence G3 is a multilayer amnion and chorion allograft providing enhanced handling characteristics. BioDDryFlex is a single-layer amniotic allograft for ...

8.

withpower.com

withpower.com/trial/phase-3-prostatectomy-4-2022-4bd0a

BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted ...

Prior Safety DataThis treatment has passed at least one previous human trial. What You Need to Know Before You Apply. What is the purpose of this trial? This ...

9.

woundreference.com

woundreference.com/p/topic?id=biodfence-g3

BioDFence® G3

BioDFence G3 is a multilayer amnion and chorion allograft that covers and protects underlying tissues. See clinical, coding and reimbursement information.