DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)

Study Overview
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Brief Summary
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The investigators will examine the beneficial impacts of applying of dHACM on the preserved neurovascular bundles (cavernosal nerves) and the prostate bed during robotic assisted laparoscopic prostatectomy. Such application can result in promotion of soft tissue healing and reduction of inflammation at the operative site and thus an acceleration of return of potency regulating cavernosal nerves.

Detailed Description
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The overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/chorion membrane (dHACM) in reducing neurovascular bundle inflammation in prostate cancer patients undergoing bilateral full nerve sparing robotic assisted laparoscopic radical prostatectomy (RALP). Specifically, this study compares potency outcomes in patients who had full nerve sparing RALP procedures with dHACM application to the neurovascular bundles to that of full nerve sparing RALP without dHACM application to neurovascular bundles. Patients will be randomized to one of two possible treatment groups: Group 1 - Treatment Group ( Full Nerve Sparing RALP + AmnioFix®) Group 2 - Control Group ( Full Nerve Sparing RALP alone)

Official Title
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A Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane (dHACM) in Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RALP) - Effect on Potency Outcomes

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Procedure: RALP using full nerve sparing technique
* Other: dHACM Application


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 examination Have ability to provide full written consent Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, 7,8 or 9 Planned elective radical prostatectomy with bilateral full nerve sparing technique Patients who currently have a pre-operative SHIM > 19 Negative urinalysis within 7 days prior to date of surgery 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, including diabetes or 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 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 Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin) 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 currently enrolled in another study. Concurrent enrollment in another study is prohibited 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dHACM<br>This group will receive RALP using full nerve sparing technique plus dHACM application. | Procedure: RALP using full nerve sparing technique<br>* RALP using full nerve sparing technique<br>Other: dHACM Application<br>* 2x12 sheet of dHACM applied to the neurovascular bundle<br>* Other names: HCT/P Part 361;|
| Other: Control<br>This group will receive RALP using full nerve sparing technique only. | Procedure: RALP using full nerve sparing technique<br>* RALP using full nerve sparing technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potency as assessed by Sexual Health Inventory for Men (SHIM) Score | As measured by SHIM | 12 months | 
| Return to sexual function | Patient directed questionnaire | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continence | As assessed by American Urological Association (AUA) score | 12 months | 
| Continence | Patient directed questionnaire | 12 months |