Neurovascular Bundle Protection With an Amnion/Chorion Membrane Allograft to Improve Postoperative Functional Recovery: A Randomized Comparison to Standard Techniques
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Reducing Neurovascular Bundle Inflammation in Prostate Cancer Patients Undergoing Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RARP)
研究概览
简要总结
The goal of this clinical research study is to learn about the safety and the effectiveness of using AmnioFix® (dehydrated human amnion/chorion membrane, also called dHACM) to help improve the return of erectile function and bladder control in patients after robotic assisted laparoscopic radical prostatectomy (RARP).
dHACM is a section of tissue made from part of the placenta donated by a mother during a C-section. It looks like a small piece of tissue paper and is wrapped around the nerve bundles in the surgical area. The tissue may help the body's normal healing process.
详细描述
Study Groups:
If participant is eligible and agrees to take part in the study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Participant will have an equal chance of being in either group. This is done because no one knows if one study group is better, the same, or worse than the other group:
- If participant is in Group 1, they will have RARP with dHACM.
- If participant is in Group 2, they will have RARP alone.
Participant will not be told which group they are assigned to until they reach the end of the study. Participant will sign a separate consent form for the surgery that explains the risks.
During Surgery:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects between the ages 35-75
- •Primary diagnosis of prostate cancer selected for surgical intervention by one of the six protocol surgeons (Chapin, Davis, Matin, Pettaway, Pisters, Ward).
- •Have a willingness to comply with follow-up HRQOL (health related quality of life) surveys and PSA assessments.
- •Have ability to provide full written consent.
- •Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, 7,8 or
- •Planned elective radical prostatectomy with bilateral nerve sparing technique that can include high or low fascia.
- •Negative urinalysis within 30 days prior to date of surgery
排除标准
- •High-risk cancer planned for neoadjuvant therapy, full or partial excision of one or both neurovascular bundles.
- •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.
- •Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications.
- •In the opinion of the PI, has a history of drug or alcohol abuse within last 12 months.
- •Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin).
- •Patients with a history of more than two weeks treatment with immuno-suppressants (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 currently enrolled in another study. Concurrent enrollment in another study is prohibited expect for the control arm which can be used for other protocols with HRQOL endpoints with similar instruments.
- •Has had prior hormonal therapy such as Lupron or oral anti-androgens.
- •Unwilling to participate in follow-up clinical appointments at MDACC.
结局指标
主要结局
Reducing Neurovascular Bundle Inflammation in Prostate Cancer Patients Undergoing Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RARP)
时间窗: 3 months
Outcome determined by a 10-point improvement in 3-month post-prostatectomy sexual function score using the Expanded Prostate Cancer Index Composite (EPIC) 26 in patients treated with the AmnioFix® graft compared to standard treatment.
次要结局
未报告次要终点