BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy

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

Detailed Description
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The purpose of this study is to build on our experience of amniotic membrane use in Robotic Assisted Radical Prostatectomy for prostate cancer, we aim to evaluate clinical outcomes related to the use of BioDFence® G3; a tri-layered amniotic membrane. BioDFence® G3 is regulated by the FDA as a 361 HCT/P for use from head to toe as a tissue barrier for soft tissue repair and as a wound covering. For the purpose of this study BioDFence® G3 will be placed on the neurovascular bundles by the surgeon during the robotic assisted radical prostatectomy procedure that the participant has elected as their primary treatment for prostate cancer. The potential benefits that will be assessed are an earlier return of potency after surgery as evidenced by The Sexual Health Inventory for Men (SHIM) questionnaire score and self-reported sexual function and secondarily looking at continence outcomes measured by The American Urological Association (AUA) questionnaire form and self-reported urinary function.

Official Title
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Treatment Protocol With BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy: A Prospective Open Label Single-Center Study

Conditions
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Prostate Cancer, Prostatectomy, Erectile Dysfunction Following Radical Prostatectomy, Incontinence, Urinary

Intervention / Treatment
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* Biological: BioDFence G3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects between the ages 40-70. Primary diagnosis of prostate cancer requiring surgical intervention Have a willingness to comply with follow-up requirements. Have ability to provide full written consent. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, or 7. Planned elective radical prostatectomy with bilateral full nerve sparing technique. Patients who currently have a pre-operative SHIM > 19 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 any condition(s), which seriously compromises the subject's ability to participate in this study or has a known history of poor adherence with medical treatment. Has comorbid conditions that can be confused with or can exacerbate the condition of erectile dysfunction, including: Diabetes Type I or Type II Advanced atherosclerotic vascular disease Is unable to sign or understand informed consent. Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor. 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. Known sensitivity to glutaraldehyde or ethanol. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. Has had prior hormonal therapy such as Lupron or oral anti-androgens. Living outside of United States Partial nerve sparing technique used during Radical Prostatectomy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: All of the patients will be recruited from patients seen in the principal investigator's (PI's) hospital and practice. The offer to participate will be extended to all eligible subjects for the importance of a representative sample. No women, children or prisoners will be enrolled in this study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm Study Group<br>Placement of a sheet of BioDFence G3 to the neurovascular bundle. | Biological: BioDFence G3<br>* Placement of a sheet of BioDFence® G3 will be applied to the neurovascular bundle on participants undergoing an elective Full Nerve Sparing Radical Prostatectomy for primary treatment of prostate cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to potency | Outcome measured by the Sexual Health Inventory for Men (SHIM) score and patient reported potency erectile function score. | 14 days to 12 months post prostatectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to continence | Outcome measured by the American Urological Association (AUA ) score and patient reported number of urinary sanitation pads used daily. | 14 days to 12 months post prostatectomy |