NCT06940271 · Mayo Clinic
Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
(RAP)
What this study 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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Negative urinalysis within 30 days prior to date of surgery
- 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
Where
- Jacksonville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations