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

September 9, 2026 updated by: Mayo Clinic

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
        • Principal Investigator:
          • Ram Pathak, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Supportive care (MLG-Complete allograft)
Patients undergo placement of MLG-Complete allograft to nerve bundles over 5 minutes during standard of care nerve-sparing RARP.
Other: Survey Administration
Ancillary studies
Procedure: Allografting
Undergo placement of MLG-Complete allograft
Other Names:
  • allograft

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)
Time Frame: 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.
Baseline [time of robot-assisted radical prostatectomy (RARP)]
Incidence of serious adverse events related to graft placement
Time Frame: 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.
Up to 6 weeks post-RARP

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average time for return of potency
Time Frame: 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.
At 6-weeks and 3-, 6-, and 12-months post RARP
Average time for return to continence
Time Frame: At 6-weeks and 3-, 6-, and 12-months post-RARP
Return to continence will be defined as use of =< 1 pad post-RARP.
At 6-weeks and 3-, 6-, and 12-months post-RARP
Change in AUASS
Time Frame: 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.
At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Change in Quality of Life - AUASS survey
Time Frame: 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.
At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Change in ICIQ-UI
Time Frame: 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.
At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Change in QoL - EPIC-26
Time Frame: 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.
At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Unplanned interactions with the healthcare team
Time Frame: 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.
Up to 12 weeks
Cost/value analysis
Time Frame: 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.
Up to 12 months post-RARP
Change in SHIM
Time Frame: 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).
At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ram A. Pathak, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MC240501 (Other Identifier: Mayo Clinic)
  • NCI-2025-02552 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 23-013215 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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