Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. The study will also examine the long term outcomes on erectile function, continence and overall quality of life in the enrolled subjects.

Official Title
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A Pilot Study to Assess the Technical Feasibility of Robotic Assisted Laparoscopic Interpositioning of the AVANCETM Nerve Graft for Reconstruction of the Neurovascular Bundle, With a Twenty-four Month Follow-up Term to Assess Efficacy

Conditions
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Peripheral Nerve Injury, Prostate Cancer, Radical Prostatectomy, Nerve Reconstruction, Cavernous Nerve Injury

Intervention / Treatment
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* Other: Processed Human Nerve Tissue Scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age, but ≤70 years of age; IIEF EF Domain*1 score ≥ 22; be able to effectively communicate with study personnel; be considered by the physician to be available for subsequent visits; be willing to comply with all aspects of the treatment and evaluation schedule over a 24 month duration; sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures; and require radical prostatectomy. Exclusion Criteria: prior surgery in the last 6 months which could affect sexual function; history of Peyronie's disease; significant neurological disorder (i.e. multiple sclerosis, peripheral neuropathy); treatment for major psychiatric disorders; history of penile implant or prosthesis; history of diabetic neuropathy; life expectancy of less than two years; concurrently involved in another investigational study; uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is present at screening; currently receiving or planned treatment with chemotherapy or radiation therapy; diagnosis of bony metastasis; known allergy or severe intolerance to PDE-5 inhibitors; or cardiac pacing equipment or other electro-mechanical devices which preclude the use of CaverMap™ neurostimulator.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avance Nerve Graft<br>Processed Human Nerve Tissue Scaffold | Other: Processed Human Nerve Tissue Scaffold<br>* Implantation of appropriate length of processed human nerve scaffold at the time of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon Assessment of Technical Feasibility |  | At time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile Recovery Rates |  | Month 1, 3, 6, 9, 12, 18 and 24 | 
| Continence Rates |  | Month 1, 3, 6, 9, 12, 18 and 24 | 
| Quality of Life Questionnaire |  | Month 1, 3, 6, 9, 12, 18 and 24 | 
| Adverse Events |  | Month 1, 3, 6, 9, 12, 18 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nerve Repair, Erectile Function, Prostate Cancer, Robot Assisted Laparoscopic Prostatectomy, Continence