Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Pr… (NCT06940271) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
United States45 participantsStarted 2025-08-14
Plain-language 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 prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being. The goal of nerve-sparing radical prostatectomy is to preserve erectile and urinary function, but damage to the surrounding nerves and blood vessels can still occur causing the patient to experience the complications. An allograft is the transplant of an organ, tissue, or cells from one individual to another individual of the same species who is not an identical twin. The MLG-Complete allograft is made up of perinatal tissue and is placed on the nerve bundles during a nerve-sparing RARP. It is meant to serve as a barrier and provide coverage to the nerve bundles from the surrounding environment, which may improve post-nerve-sparing RARP complications.
Who can participate
Age range
45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is described as a feasibility study with a phase listed as 'NA,' which suggests it's very early-stage research focused on whether the nerve-wrapping technique is even practical to perform — what does that mean for what we'd actually know about whether it helps with outcomes like continence or sexual function after my surgery?
2The trial is specifically measuring whether placing this multi-layer perinatal tissue allograft around the nerves doesn't add significant time to the operation — how might a longer or more complex surgery affect my personal risk profile given my specific health situation?
3One of the primary things being tracked is serious adverse events related to the graft itself — what kinds of complications are considered 'serious' in this context, and how does that risk compare to a standard nerve-sparing prostatectomy without the graft?
4Since this study covers a range of stages from Stage I through Stage III, would my specific cancer stage and the degree of nerve-sparing possible in my case make me a particularly good or poor fit to even discuss with the trial team?
5Is there a standard-of-care approach to protecting the nerves during prostatectomy that I should consider first, or would participating in this trial mean I'd be receiving something meaningfully different from what you'd otherwise recommend for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)
Timeframe: Baseline [time of robot-assisted radical prostatectomy (RARP)]
2
Incidence of serious adverse events related to graft placement