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

Официальное название

RAP: Prospective Pragmatic Multi-Site Trial Evaluating the Feasibility and Effect of Wrapping the Cavernous Nerves With a Novel Multi-Layer Perinatal Tissue Allograft During Prostatectomy

Обзор

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.

Вмешательства

• Процедура Allografting
  Undergo placement of MLG-Complete allograft
• Другое Survey Administration
  Ancillary studies

Первичные конечные точки

• Ability to place MLG-Complete allograft without lengthening operative time (Feasibility) [Срок оценки: Baseline [time of robot-assisted radical prostatectomy (RARP)]]
• Incidence of serious adverse events related to graft placement [Срок оценки: Up to 6 weeks post-RARP]

Вторичные конечные точки (9)

• Average time for return of potency [Срок оценки: At 6-weeks and 3-, 6-, and 12-months post RARP]
• Average time for return to continence [Срок оценки: At 6-weeks and 3-, 6-, and 12-months post-RARP]
• Change in SHIM [Срок оценки: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP]
• Change in AUASS [Срок оценки: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP]
• Change in Quality of Life - AUASS survey [Срок оценки: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP]
• Change in ICIQ-UI [Срок оценки: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP]
• Change in QoL - EPIC-26 [Срок оценки: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP]
• Cost/value analysis [Срок оценки: Up to 12 months post-RARP]
• Unplanned interactions with the healthcare team [Срок оценки: Up to 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Mayo Clinic in Florida — Jacksonville

Идентификаторы

NCT: NCT06940271 · MC240501 · NCI-2025-02552 · 23-013215 · MC240501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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