RecruitingNot ApplicableNCT06940271

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

RAP: Prospective Pragmatic Multi-Site Trial Evaluating the Feasibility and Effect of Wrapping the Cavernous Nerves With a Novel Multi-Layer Perinatal Tissue Allograft During Prostatectomy


Sponsor

Mayo Clinic

Enrollment

25 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether wrapping the nerves around the prostate with a special tissue graft during prostate cancer surgery can help men recover erectile function faster after their operation. **You may be eligible if...** - You are a man aged 45 or older - You have been diagnosed with prostate cancer that is confined to the prostate (not spread) - You are scheduled for prostate removal surgery (radical prostatectomy) where both nerve bundles will be preserved - You currently have no erectile dysfunction (you can get erections without assistance) - You are interested in penetrative sexual activity - You have no urinary tract infection **You may NOT be eligible if...** - Your cancer is high-risk and requires removal of the nerve bundles - You have had previous pelvic surgery or radiation therapy - You have obesity (BMI over 40) - You are on hormone therapy (such as Lupron) or immunosuppressant drugs - You have poor urinary control already (using pads for leakage) - You have a significant neurological or psychiatric condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAllografting

Undergo placement of MLG-Complete allograft

OTHERSurvey Administration

Ancillary studies


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT06940271


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