This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after nerve-sparing robot-assisted radical prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being. The goal of nerve-sparing radical prostatectomy is to preserve erectile and urinary function, but damage to the surrounding nerves and blood vessels can still occur causing the patient to experience the complications. An allograft is the transplant of an organ, tissue, or cells from one individual to another individual of the same species who is not an identical twin. The MLG-Complete allograft is made up of perinatal tissue and is placed on the nerve bundles during a nerve-sparing RARP. It is meant to serve as a barrier and provide coverage to the nerve bundles from the surrounding environment, which may improve post-nerve-sparing RARP complications.
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
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
Single group
Allografting
Procedure/SurgeryUndergo placement of MLG-Complete allograft
Survey Administration
Other interventionAncillary studies
Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)
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
Will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Average time for return of potency
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
Return to continence will be defined as use of =\< 1 pad post-RARP.
Change in SHIM
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
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.
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