Patient-Reported Erectile Recovery and Quality of Life Outcomes With Lyopreserved Placental Tissue Applied Directly Over Neurovascular Bundle During Nerve Sparing Radical Prostatectomy Versus Standard of Care

Study Overview
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Brief Summary
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Surgical implantation of Lyopreserved Placental Tissue (LPT) is FDA approved and has been used extensively in wound care. The use is expanding and more recently, LPT has been used in the management of diabetic foot ulcers, acute and chronic surgical wounds, various fistulas and even as a nerve wrap on the common peroneal nerve. Surgical technique for nerve-sparing prostatectomy has evolved continuously since first described by Walsh in 1982 and is now commonly performed with robotic assistance. The investigators intend to study whether placement of LPT over the spared neurovascular bundle during nerve-sparing robotic prostatectomy will improve return to potency and/or continence after robotic radical prostatectomy for prostate cancer. Patients with a preoperative Sexual Health Inventory for Men (SHIM) score > 19 (moderate or high pre-op sexual function) planning to undergo robotic-assisted laparoscopic prostatectomy will be randomized to receive direct placement of LPT over the preserved neurovascular bundles vs standard of care. Patients will independently report erectile function and continence at 1 months, 3 months, 6 months and 1 year after surgery. Primary outcomes would include mean time to achieve potency, percentage of group achieving potency at each time point, and mean change in SHIM score. Secondary outcomes would include mean time to achieve continence. The investigators will also report any adverse events.

Official Title
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Patient-Reported Erectile Recovery and Quality of Life Outcomes With Lyopreserved Placental Tissue Applied Directly Over Neurovascular Bundle During Nerve-Sparing Radical Prostatectomy Versus Standard of Care

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Stravix lyopreserved placental tissue (LPT)
* Procedure: Radical prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male sex 40 to 65 years of age with localized prostate cancer (clinical stage less than or equal to T2a, Gleason grade less than or equal to 3+4=7 (Gleason 8 or 4+3=7 will be excluded), Prostate-Specific Antigen (PSA) less than or equal to 10 ng/mL) Scheduled to undergo curative radical prostatectomy applying bilateral nerve-sparing procedure Intact pre-surgical erectile function (International Index of Erectile Function [IIEF]-5 / Sexual Health Inventory for Men (SHIM) score greater than or equal to 18) Willingness to attempt intercourse at least 5 times per month following surgery. Has a sexual partner of at least 6 months with current sexual activity (within the past 4 weeks) Exclusion Criteria: Known penile deformity or a history of Peyronie's disease Pre or postoperative androgen therapy Pre or postoperative radiation therapy History of high or low blood pressure that is not controlled Taking nitrates medications History of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction History of drug or alcohol abuse Current smoker has a 20 pack/year history of cigarette smoking History of acute or chronic depression History of liver problems or kidney problems History of retinitis pigmentosa or severe vision loss, including a condition called NAION History of spinal trauma or surgery to the brain or spinal cord Other contraindications to the use of phosphodiesterase inhibitor (PDE) 5 inhibitors History of known sensitivities to any of the following reagents used for processing, disinfection, and storage, which may remain on the product: Lyopreservation Solution: 18.9% w/v Trehalose in Dulbecco's Phosphate Buffered Saline Disinfection Solution: 0.5% v/v Gentamicin Sulfate, 0.1% v/v Vancomycin reconstituted in Water for Injection (WFI), 1% v/v Amphotericin B, 98.4% Dulbecco's Modified Eagle's Medium (DMEM) Processing Solution: DMEM, Dulbecco's Phosphate Buffered Saline (dPBS), 11% Anticoagulant Citrate Dextrose Solution in Saline, Formula A (ACD-A), 1.7% w/v Trehalose in Dulbecco's Phosphate Buffered Saline

Ages Eligible for Study
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Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single center, randomized; singe blinded, two-arm trial comparing the effects of direct placement of lyopreservation placental tissue over the spared neurovascular bundles vs. standard care (no placement of tissue) on erectile recovery and quality of life in patients undergoing bilateral nerve sparing radical prostatectomy for prostate cancer. The sample size will be 30 patients randomized to each study arm (60 patients total).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stravix<br>Direct placement of LPT over the spared neurovascular bundles during bilateral nerve sparing radical prostatectomy for prostate cancer. | Drug: Stravix lyopreserved placental tissue (LPT)<br>* Participants will undergo surgical implantation of Stravix lyopreserved placental tissue (LPT) during a standard of care radical prostatectomy.<br>|
| Sham Comparator: Standard of Care<br>Standard care (no placement of tissue) bilateral nerve sparing radical prostatectomy for prostate cancer. | Procedure: Radical prostatectomy<br>* Standard care (no placement of tissue)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in erectile function as assessed by the International Index of Erectile Function (IIEF) Score | The primary outcome variable is the patient's score on the IIEF questionnaire (erectile function domain) at 1,3, 6, 9, 12, and 18 months post-surgery. A comparison of changes in the initial IIEF score will be evaluated to determine treatment efficacy. The IIEF contains 15 questions. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Overall scores will be categorized as follows: 1-10: Severe Erectile Dysfunction 11-16: Moderate dysfunction. 17-21: Mild to moderate dysfunction 22-25: Mild dysfunction 26-30: No dysfunction | 1, 3, 6, 9, 12 and 18 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in erectile function and overall quality of life as assessed by the Expanded Prostate cancer Index Composite (EPIC) score from questionnaires | The following questionnaires will be combined into a composite index EPIC score. EPIC scoring involves linear standardization of the response for each questionnaire to a 0 to 100 scale. Using the item groupings for each health-related quality of life (HRQOL) Domain Summary Score or Subscale score, values are averaged for all items within a group to create the summary or subscale score. A higher score represents better HRQOL. EPIC scores will be compared at each time point. A clinically relevant increase for the sexual domain is 10-12 points. The Quality of Erection Questionnaire (QEQ) assesses erection in terms of hardness, onset, duration, and changes in erection quality. There are 6 questions. The Short Form Survey (SF-12) assesses 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, etc with 1-2 questions per domain. The MUSIC questionnaire assesses four domains: urinary, bowel, sexual and hormonal. Each domain consists of 2-4 questions. | 1, 3, 6, 9, 12 and 18 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectile dysfunction, radical prostatectomy