Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic prostatectomies.

Official Title
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A Prospective Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy (RALP)- Effect on Nerve Protection.

Conditions
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Pudendal Nerve

Intervention / Treatment
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* Procedure: Robotic Assisted Laparoscopic Prostatectomy
* Other: Application of Absorbable Hemostat
* Other: Application of dehydrated human amniotic membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 45-70 Clinically localized prostate cancer with Gleason score 6 or 7 SHIM Score greater than or equal to 16 in the absence of medication Feasibility to perform unilateral or bilateral nerve sparing RALP Exclusion Criteria: Clinically locally advanced cancer and/or with Gleason score 8 or 9. Difficulty performing nerve sparing RALP. Prior surgery at the site. Site exhibits clinical signs and symptoms of infection. SHIM score at screening <16. Current use of anticoagulant medication including Coumadin, Plavix, etc. Has had salvage prostatectomy - patients who failed prior therapies including external radiation therapy, cryotherapy, etc. Has prior radiation therapy treatment at the site. Prior hormonal therapy such as Lupron or oral anti-androgens. Non-mobile, i.e. not ambulatory or bed ridden. The presence of comorbidities that can be confused with or can exacerbate the condition including: diabetes advanced atherosclerotic vascular disease 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. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening. Unable to comply with penile rehabilitation. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV. Patients who are unable to understand the aims and objectives of the trial. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment. Currently taking medications which could affect graft incorporation (supervising physician's discretion). Allergic to gentamicin and/or streptomycin. Damage to neurovascular bundles during surgery.

Ages Eligible for Study
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Minimum Age: 45 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Robotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat. | Procedure: Robotic Assisted Laparoscopic Prostatectomy<br>* Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique<br>Other: Application of Absorbable Hemostat<br>* Application of Surgicel® SNoW Absorbable Hemostat by Johnson and Johnson on the neurovascular bundle after removal of the cancerous prostate.<br>* Other names: Surgicel® SNoW;|
| Experimental: AmnioFix<br>Robotic Assisted Laparoscopic Prostatectomy with application of dehydrated human amniotic membrane. | Procedure: Robotic Assisted Laparoscopic Prostatectomy<br>* Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique<br>Other: Application of dehydrated human amniotic membrane<br>* Application of dehydrated human amniotic membrane (DHAM) on the neurovascular bundle after removal of the cancerous prostate.<br>* Other names: AmnioFix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return of erectile function. |  | Up to 6 months | 
| Pain scores. |  | 10 days, 4 weeks, 3 months, and 6 months |