Wrapping nerves with a multi-layer perinatal tissue graft during prostate removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study places a multi-layer perinatal tissue allograft (MLG-Complete) around the neurovascular bundles during planned bilateral nerve-sparing robot-assisted radical prostatectomy. Eligible men are adults with localized prostate cancer, baseline normal erectile function (SHIM ≥ 19), negative urine testing, and interest in penetrative intercourse. Patients will follow standard penile rehabilitation protocols and complete postoperative surveys to track erectile function and urinary continence over follow-up. The procedure and outcomes are being tested at a single site (Mayo Clinic in Florida).

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Ram A. Pathak, MD — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.