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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Supportive care (MLG-Complete allograft)
Patients undergo placement of MLG-Complete allograft to nerve bundles over 5 minutes during standard of care nerve-sparing RARP.
干预措施: Survey Administration (Other)
Supportive care (MLG-Complete allograft)
Patients undergo placement of MLG-Complete allograft to nerve bundles over 5 minutes during standard of care nerve-sparing RARP.
干预措施: Allografting (Procedure)
结局指标
主要结局
Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)
时间窗: Baseline [time of robot-assisted radical prostatectomy (RARP)]
Feasibility is defined as the overall technical ability to place the MLG-Complete allograft in included patients without significantly lengthening operative time. This will be defined by a yes/no evaluation by the surgeon.
Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)
时间窗: Baseline [time of robot-assisted radical prostatectomy (RARP)]
Feasibility is defined as the overall technical ability to place the MLG-Complete allograft in included patients without significantly lengthening operative time. This will be defined by a yes/no evaluation by the surgeon.
Incidence of serious adverse events related to graft placement
时间窗: Up to 6 weeks post-RARP
Will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- Cost/value analysis(Up to 12 months post-RARP)
- Average time for return of potency(At 6-weeks and 3-, 6-, and 12-months post RARP)
- Average time for return to continence(At 6-weeks and 3-, 6-, and 12-months post-RARP)
- Change in AUASS(At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP)
- Change in Quality of Life - AUASS survey(At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP)
- Change in ICIQ-UI(At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP)
- Change in QoL - EPIC-26(At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP)
- Unplanned interactions with the healthcare team(Up to 12 weeks)
- Change in Quality of Life - AUASS survey(At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP)
- Average time for return to continence(At 6-weeks and 3-, 6-, and 12-months post-RARP)
- Change in AUASS(At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP)
- Average time for return of potency(At 6-weeks and 3-, 6-, and 12-months post RARP)
- Change in SHIM(At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP)
- Change in ICIQ-UI(At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP)
- Change in QoL - EPIC-26(At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP)
- Cost/value analysis(Up to 12 months post-RARP)
- Unplanned interactions with the healthcare team(Up to 12 weeks)