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

NCT06940271 | Recruiting

• 3 other identifiers: MC240501NCI-2025-0255223-013215
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Localized Prostate Carcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline [time of robot-assisted radical prostatectomy (RARP)]

• 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.

  Up to 6 weeks post-RARP

Secondary Outcomes (9)

• Average time for return of potency

  At 6-weeks and 3-, 6-, and 12-months post RARP

• Average time for return to continence

  At 6-weeks and 3-, 6-, and 12-months post-RARP

• Change in SHIM

  At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP

• Change in AUASS

  At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP

• Change in Quality of Life - AUASS survey

  At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP

Study Arms (1)

Supportive care (MLG-Complete allograft)

EXPERIMENTAL

Patients undergo placement of MLG-Complete allograft to nerve bundles over 5 minutes during standard of care nerve-sparing RARP.

Procedure: Allografting; Other: Survey Administration

Interventions

Allografting PROCEDURE

Undergo placement of MLG-Complete allograft

Also known as: allograft

Supportive care (MLG-Complete allograft)

Survey Administration OTHER

Ancillary studies

Supportive care (MLG-Complete allograft)

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Transplantation, Homologous

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Ram A. Pathak, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): July 30, 2030
• Study Completion (Estimated): July 30, 2030
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)