Radical Prostectomy (RAP): Prospective Trial Evaluating Return to Continence and Potency Following Radical Prostatectomy Using Novel Multi-Layer Perinatal Issue alloGraft
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Average time for return to potency
研究概览
简要总结
The purpose of this research is to determine the effectiveness of using human Umbilical Cord (UC) allograft to help improve return to erectile function and bladder control in patients following robot-assisted radical prostatectomy (RARP).
详细描述
Participation in this study will involve MLG (Multi-Layered Perinatal Tissue Allograft) allograft, which is implanted during the surgery. This allograft is currently FDA approved and used for several type of surgeries.
The Multi-Layered Perinatal Tissue Allograft- (MLG) is processed from tissue according to the American Association of Tissue Banks (AATB) standards, and is regulated as a cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act. The grafts are distributed by Samaritan Biologics, LLC; an FDA-registered tissue bank.
The MLG allograft will be placed on each neurovascular bundle (NVB) bilaterally.
MLG is supplied as sterile sheets having dimensions of 2cm x 2cm and a thickness of approximately 0.8-1.0mm thick.
Participants receiving MLG will have it placed around the neurovascular bundle. Placement of the graft should not take over 5 minutes of time to impact overall surgical time length significantly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects with at least age of 30 to 65
- •Primary diagnosis of prostate cancer selected for surgical intervention (Radical Prostatectomy)
- •Primary diagnosis of organ confined 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 < 14 ) prior to date of surgery
- •Patient has the willingness to comply with instruction of the investigator
- •Patient has the willingness to comply with follow-up surveys
- •Have ability to provide full written consent.
排除标准
- •High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
- •Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
- •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 that have had prior hormonal therapy such as Lupron or oral anti-androgens
- •Patients with 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 BMI > 40 kg/m2
- •History of open pelvic surgery within 5 years except for hernia repair
- •Poorly controlled diabetes (A1C >8.5%)
- •Scheduled at the time of screening 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 PI, has a history of drug or alcohol abuse within last 12 months
- •Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)
- •Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
研究组 & 干预措施
Umbilical Cord Allograft Recipients
Male patients undergoing Robot Assisted Radical Prostectomy with bilateral nerve sparing technique will remain eligible to receive allograft during the surgery.
干预措施: MLG (Multi-Layered Perinatal Issue Allograft) Allograft (Device)
结局指标
主要结局
Average time for return to potency
时间窗: 12 month post-op
Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 \> 3)
Average time for return to continence
时间窗: 12 month post-op
Return to continence will be defined as use of \< 1 pad post-RARP
Average time for return to potency
时间窗: 1 month post-op
Early recovery in potency will be measured as + 4 points of total Sexual Health Inventory for Men (SHIM) score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-robot-assisted radical prostatectomy (RARP) (Tool: SHIM, Q2 \> 3)
Average time for return to potency
时间窗: 3 month post-op
Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 \> 3)
Average time for return to potency
时间窗: 6 month post-op
Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 \> 3)
Average time for return to continence
时间窗: 1-2 days post-op
Return to continence will be defined as use of \< 1 pad post-RARP
Average time for return to continence
时间窗: 1 month post-op
Return to continence will be defined as use of \< 1 pad post-RARP
Average time for return to continence
时间窗: 3 month post-op
Return to continence will be defined as use of \< 1 pad post-RARP
Average time for return to continence
时间窗: 6 month post-op
Return to continence will be defined as use of \< 1 pad post-RARP
次要结局
- Abdominal VAS (Visual Analog Scale) Pain Score(Post-op Days 1 and 2)
- Expanded prostate cancer index composite-26 (EPIC-26) Score(Months 1, 3, 6, and 12)
- Value analysis for a historical subset of patients who underwent same surgery as sexual health inventory for men (SHIM)-matched controls(Month 1 post-op)
- Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores(Day 1 post-op)
- Costs of prescription(Month 12 post-op)