Recruiting

MLG-Complete

Sponsor:

Mayo Clinic

Code:

NCT06940271

Conditions

Localized Prostate Carcinoma

Stage I Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Allografting

Survey Administration

Study Details

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

Study ID

NCT06940271

Start date

Aug 14, 2025

Status verified date

Aug, 2026

Completion date

Jul 30, 2030

Anticipated

Primary completion date

Jul 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Allografting

Undergo placement of MLG-Complete allograft

Survey Administration

Ancillary studies

Primary outcome measure

  • Ability to place MLG-Complete allograft without lengthening operative time (Feasibility) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Ram Pathak, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-17.