Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
NCT ID: NCT06940271
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-08-14
2030-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Allografting
Undergo placement of MLG-Complete allograft
Survey Administration
Ancillary studies
Interventions
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Allografting
Undergo placement of MLG-Complete allograft
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Ram A. Pathak, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2025-02552
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-013215
Identifier Type: OTHER
Identifier Source: secondary_id
MC240501
Identifier Type: OTHER
Identifier Source: secondary_id
MC240501
Identifier Type: -
Identifier Source: org_study_id