Actively Recruiting
Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
Led by Mayo Clinic · Updated on 2025-11-10
25
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 45 years or older
- Diagnosed with prostate cancer and selected for surgical radical prostatectomy
- Primary diagnosis of organ-confined localized prostate cancer
- Planned elective nerve-sparing bilateral radical prostatectomy
- Negative urinalysis within 30 days before surgery
- No erectile dysfunction with SHIM score 19 or higher at consultation
- Willing to follow investigator instructions and complete follow-up surveys
- Ability to provide written informed consent
- Negative urinary tract infection at consultation
- Interested in penetrative sexual intercourse
You will not qualify if you...
- High-risk cancer requiring neoadjuvant therapy or partial/complete excision of neurovascular bundles
- Unable to comply with penile rehabilitation treatments including medications and devices
- History of immunosuppressant treatment over 14 days, recent chemotherapy, or ongoing such treatment
- Prior hormonal therapy such as Lupron or oral anti-androgens
- Poor urinary control requiring pads at baseline
- Previous pelvic radiation treatment
- Prior simple prostatectomy or transurethral prostate surgery
- Obesity with body mass index over 40 kg/m2
- More than five prior open pelvic surgeries excluding hernia repair
- Scheduled chemotherapy, radiation, hormone therapy, or open surgery during the study
- Neurologic or psychiatric disorders affecting postsurgical assessments
- Conditions impairing ability to participate, consent, or adhere to treatment
- History of drug or alcohol abuse within 12 months before registration
- Allergy to aminoglycoside antibiotics such as gentamicin or streptomycin
- Received investigational drugs within 30 days prior or planned during study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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