Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy

• Allografting (Procedure), also known as allograft: Undergo placement of MLG-Complete allograft
• Survey Administration (Other): Ancillary studies

Primary outcomes

• Ability to place MLG-Complete allograft without lengthening operative time (Feasibility) [Baseline [time of robot-assisted radical prostatectomy (RARP)]]: Feasibility is defined as the overall technical ability to place the MLG-Complete allograft in included patients without significantly lengthening operative time. This will be defined by a yes/no evaluation by the surgeon.
• Incidence of serious adverse events related to graft placement [Up to 6 weeks post-RARP]: Will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Secondary outcomes

• Average time for return of potency [At 6-weeks and 3-, 6-, and 12-months post RARP]: Will be defined as the ability to achieve an erection sufficient for intercourse for at least 50% of the time or at least 50% rigidity post RARP. Will be assessed using the Sexual Health Inventory for Men (SHIM) and patient-reported history. The SHIM is a five-question instrument with a score of 1-25 points. A higher score generally indicates greater ability to achieve an erection.
• Average time for return to continence [At 6-weeks and 3-, 6-, and 12-months post-RARP]: Return to continence will be defined as use of =< 1 pad post-RARP.
• Change in SHIM [At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP]: Sexual Health Inventory for Men (SHIM) scores will be collected at study enrollment, 6 weeks, 3 months, 6 month, and 12 months. The SHIM consists of five questions that explore aspects of erectile function. Scores range from 1-25. A score of 20 or higher indicates a normal degree of erectile functioning. Lower scores (10 or less) indicate moderate to severe erectile dysfunction (ED).
• Change in AUASS [At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP]: The American Urological Association Symptom Score (AUASS) consists of 5 questions related to urological symptoms over the past month. Questions are answered on a scale of 0-5 where 0=not at all and 5=almost always and one question related to nighttime urination (times per night average over the past month). A lower overall score indicates lesser urological symptoms.
• Change in Quality of Life - AUASS survey [At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP]: Assessed with a single survey question answered on a scale of 0-6 where 0=delighted and 6=terrible.
• Change in ICIQ-UI [At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP]: The International Consultation on Incontinence Questionnaire: Short Form for Urinary Incontinence (ICIQ-UI) is a 4-item questionnaire related to urine incontinence over the past 4 weeks. A higher summary scores indicates worse incontinence.
• Change in QoL - EPIC-26 [At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP]: The Expanded Prostate Cancer Index Composite (EPIC-26) is a 26-item questionnaire related to Quality of Life issues in patients with Prostate Cancer. The survey consists of 26 items under 5 domains: urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.
• Cost/value analysis [Up to 12 months post-RARP]: Costs of prescription \[Oral Phosphodiesterase 5 Inhibitor (PDE-5i), Intracavernosal injection, Alprostadil urethral suppository) or future surgery (inflatable penile prosthesis\] will be recorded.
• Unplanned interactions with the healthcare team [Up to 12 weeks]: The proportion of patients with an unplanned phone call, portal message, or unscheduled clinic, emergency room, or urgent care visit will be computed and presented. The total number of unplanned phone calls, portal messages, or health care visits will be summarized.

Sex: Male, ages: 45 Years to any

Inclusion Criteria:

* Male subjects with age ≥ 45
* Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy)
* Primary diagnosis of organ confined (i.e. localized) untreated prostate cancer
* Planned elective radical prostatectomy with bilateral nerve sparing technique
* Patient has no erectile dysfunction (SHIM score ≥ 19) at the time of consultation
* Willing to comply with instruction of the investigator
* Willing to comply with follow-up surveys
* Ability to provide written consent
* Negative urinary tract infection at the time of consultation
* Interest in penetrative sexual intercourse

Exclusion Criteria:

* High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
* Unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
* History of >14 days treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period
* Prior hormonal therapy such as Lupron or oral anti-androgens
* 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 body mass index (BMI) > 40 kg/m\^2
* History of open pelvic surgery ≤ 5 prior to registration (except for hernia repair)
* Scheduled 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 principal investigator (PI), has a history of drug or alcohol abuse ≤ 12 months prior to registration
* Allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin)
* Received administration of an investigational drug within 30 days prior to registration, and/or has planned administration of another investigational product or procedure during participation in this study

• Ram A. Pathak, MD, Principal investigator, Mayo Clinic