Continence and Potency Following Multi-Layer Perinatal Issue alloGraft

Study Overview
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Brief Summary
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The purpose of this research is to determine the effectiveness of using human Umbilical Cord (UC) allograft to help improve return to erectile function and bladder control in patients following robot-assisted radical prostatectomy (RARP).

Detailed Description
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Participation in this study will involve MLG (Multi-Layered Perinatal Tissue Allograft) allograft, which is implanted during the surgery. This allograft is currently FDA approved and used for several type of surgeries. The Multi-Layered Perinatal Tissue Allograft- (MLG) is processed from tissue according to the American Association of Tissue Banks (AATB) standards, and is regulated as a cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act. The grafts are distributed by Samaritan Biologics, LLC; an FDA-registered tissue bank. The MLG allograft will be placed on each neurovascular bundle (NVB) bilaterally. MLG is supplied as sterile sheets having dimensions of 2cm x 2cm and a thickness of approximately 0.8-1.0mm thick. Participants receiving MLG will have it placed around the neurovascular bundle. Placement of the graft should not take over 5 minutes of time to impact overall surgical time length significantly.

Official Title
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Radical Prostectomy (RAP): Prospective Trial Evaluating Return to Continence and Potency Following Radical Prostatectomy Using Novel Multi-Layer Perinatal Issue alloGraft

Conditions
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Post Operative Recovery

Intervention / Treatment
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* Device: MLG (Multi-Layered Perinatal Issue Allograft) Allograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects with at least age of 30 to 65 Primary diagnosis of prostate cancer selected for surgical intervention (Radical Prostatectomy) Primary diagnosis of organ confined untreated prostate cancer Planned elective radical prostatectomy with bilateral nerve sparing technique Negative urinalysis within 30 days prior to date of surgery Patient has no erectile dysfunction (SHIM Score < 14 ) prior to date of surgery Patient has the willingness to comply with instruction of the investigator Patient has the willingness to comply with follow-up surveys Have ability to provide full written consent. Exclusion Criteria: High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications 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 that have had prior hormonal therapy such as Lupron or oral anti-androgens Patients with poor urinary control at baseline requiring the use of pads for leakage Previous history of pelvic radiation Previous history of simple prostatectomy or transurethral prostate surgery Patients with obesity defined as BMI > 40 kg/m2 History of open pelvic surgery within 5 years except for hernia repair Poorly controlled diabetes (A1C >8.5%) Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment In the opinion of the PI, has a history of drug or alcohol abuse within last 12 months Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin) Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Male patients undergoing Robot-Assisted Radical Prostectomy and eligible will receive Human Umbilical Cord (UC) allograft. It is hypothesized that patients receiving UC allograft placed around the neurovascular bundle will facilitate earlier return to potency and continence compared to those that do not receive UC allografts.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical Cord Allograft Recipients<br>Male patients undergoing Robot Assisted Radical Prostectomy with bilateral nerve sparing technique will remain eligible to receive allograft during the surgery. | Device: MLG (Multi-Layered Perinatal Issue Allograft) Allograft<br>* MLG allografts contains more than 450 bioactive proteins including growth factors and cytokines known to modulate inflammation and promote tissue healing. MLG is supplied as sterile sheets having dimensions of 2cm x 2cm and a thickness of approximately 0.8-1.0mm thick. Participants receiving MLG will have it placed around the neurovascular bundle. Placement of the graft should not take over 5 minutes of time to impact overall surgical time length significantly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average time for return to potency | Early recovery in potency will be measured as + 4 points of total Sexual Health Inventory for Men (SHIM) score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-robot-assisted radical prostatectomy (RARP) (Tool: SHIM, Q2 > 3) | 1 month post-op | 
| Average time for return to potency | Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 > 3) | 3 month post-op | 
| Average time for return to potency | Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 > 3) | 6 month post-op | 
| Average time for return to potency | Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 > 3) | 12 month post-op | 
| Average time for return to continence | Return to continence will be defined as use of < 1 pad post-RARP | 1-2 days post-op | 
| Average time for return to continence | Return to continence will be defined as use of < 1 pad post-RARP | 1 month post-op | 
| Average time for return to continence | Return to continence will be defined as use of < 1 pad post-RARP | 3 month post-op | 
| Average time for return to continence | Return to continence will be defined as use of < 1 pad post-RARP | 6 month post-op | 
| Average time for return to continence | Return to continence will be defined as use of < 1 pad post-RARP | 12 month post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expanded prostate cancer index composite-26 (EPIC-26) Score | EPIC-26, contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best) | Months 1, 3, 6, and 12 | 
| Abdominal VAS (Visual Analog Scale) Pain Score | VAS score 0 -10: 0 indicating no abdominal pain to 10 as worst pain | Post-op Days 1 and 2 | 
| Value analysis for a historical subset of patients who underwent same surgery as sexual health inventory for men (SHIM)-matched controls | Twenty-five patients who underwent bilateral nerve sparing in the past matched by preoperative SHIM to see how they did in comparison to study cohort will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 > 3) | Month 1 post-op | 
| Costs of prescription | Oral Phosphodiesterase type 5 (PDE-5i), Intracavernosal injection, Alprostadil urethral suppository or future surgery (Inflatable penile prosthesis) to be recorded in the historical group of 25 patients. Overall expense will be measured by reviewing history. A market value of medication and treatment will be accounted. Post coverage out of pocket expense will not be reviewed separately. | Month 12 post-op | 
| Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores | Overall patient satisfaction Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) - composed of 29 items - the survey contains 19 core questions about critical aspects of patients' hospital experiences (communication with nurses and doctors, the responsiveness of hospital staff, the cleanliness and quietness of the hospital environment, communication about medicines, discharge information, overall rating of hospital, and would they recommend the hospital) - HCAHPS score is accounted as The top-box score indicates how often patients selected the most positive response category when asked about their hospital experience. The higher a hospital's top-box score, the higher it ranks. | Day 1 post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multi-Layered Perinatal Tissue Allograft, Robot-Assisted Radical Prostatectomy, Erectile Dysfunction