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MLG-Complete Allograft for Prostate Cancer Surgery

This study is looking at whether a special multi-layer tissue called MLG-Complete can help reduce common problems like erectile dysfunction and urinary incontinence after prostate cancer surgery. These problems can happen even when surgeons try to protect the nerves during a robot-assisted radical prostatectomy (RARP) for localized prostate cancer (cancer that hasn't spread). The study wants to see if placing the MLG-Complete allograft during surgery is possible without making the operation longer, and if it causes any serious side effects. You may be able to join if you are a man aged 45 or older with localized prostate cancer who is having a radical prostatectomy with nerve-sparing techniques. The study plans to enroll 25 participants, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 25 male participants. It is not specified if it is randomized or blinded.
What's involved
Participants will undergo placement of the MLG-Complete allograft during their robot-assisted radical prostatectomy. They will also complete ancillary studies, which may involve surveys.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 6 weeks after their surgery to check for any serious side effects related to the graft placement.

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NCT06940271

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

Recruiting
NAAges 45+InterventionalSupportive care
Mayo Clinic
~45 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:AllograftingSurvey Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)
Measured over Baseline [time of robot-assisted radical prostatectomy (RARP)]
+1 more outcome measured

Conditions

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

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Ram A. Pathak, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)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.

  • Incidence of serious adverse events related to graft placementUp 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.