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

Launched by MAYO CLINIC · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach to help reduce complications after a specific type of prostate surgery called nerve-sparing robot-assisted radical prostatectomy (RARP). The treatment involves using a special tissue graft made from perinatal tissue, which is designed to protect the nerve bundles during surgery. The main goal is to prevent issues like erectile dysfunction and urinary incontinence, which can significantly affect a patient's quality of life after prostate surgery.

To participate in this trial, you need to be a male aged 45 or older, diagnosed with localized prostate cancer, and scheduled for a nerve-sparing prostate surgery. It's important that you have good urinary and erectile function before the surgery. Participants will have the opportunity to help improve outcomes for future patients while receiving close follow-up care. Please note that the trial is not yet recruiting participants, and certain health conditions or medications may disqualify some individuals from joining.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male subjects with age of at least 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) prior to date of surgery
• • Patient has the willingness to comply with instruction of the investigator
• • Patient has the willingness to comply with follow-up surveys
• • Have ability to provide full written consent
• Exclusion Criteria:
• • High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
• • Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
• • Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
• • Patients that have had prior hormonal therapy such as Lupron or oral antiandrogens
• • Patients with 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 within 5 years except for hernia repair
• • Scheduled at the time of screening 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 within last 12 months
• • Is allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin)
• • Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
• • Patients not interested in penetrative sexual intercourse