Status:
RECRUITING
Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
Lead Sponsor:
Mayo Clinic
Conditions:
Localized Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Eligibility:
MALE
45+ years
Phase:
NA
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 prostatectom...
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
- 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
- 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
Key Trial Info
Start Date :
August 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2030
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06940271
Start Date
August 14 2025
End Date
July 30 2030
Last Update
November 10 2025
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980