Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score
研究概览
简要总结
The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participants will be blinded to the treatment they receive. To minimize bias on the surgical team during the nerve sparing process, the surgical team will be blinded to arm allocation until after the prostate is removed.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1. Men aged 40 to 80 years with localized prostate cancer who are undergoing RARP at the University of Miami (UM).
排除标准
- •Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED).
- •Men with baseline EPIC26 scores <
- •Patients with complete, bilateral nerve resection.
- •Previous treatment for prostate cancer.
- •Previous history of pelvic radiation.
- •Patients with impaired decision-making capacity.
研究组 & 干预措施
Membrane Arm: dHACM Group
Participants will undergo standard of care robot-assisted radical prostatectomy (RARP) surgery and the dehydrated Human Amnion Chorion Membrane (dHACM) membrane placed after removal of the prostate. Participants will be in the group for approximately 12 months.
干预措施: BioDFence G3 Placental Tissue Membrane (Biological)
Membrane Arm: dHACM Group
Participants will undergo standard of care robot-assisted radical prostatectomy (RARP) surgery and the dehydrated Human Amnion Chorion Membrane (dHACM) membrane placed after removal of the prostate. Participants will be in the group for approximately 12 months.
干预措施: Robot-Assisted Radical Prostatectomy (Procedure)
Control Arm: No dHACM Group
Participants will undergo standard of care RARP surgery but will have no dehydrated Human Amnion Chorion Membrane (dHACM) placed after removal of the prostate. Participants will be in the group for approximately 12 months.
干预措施: Robot-Assisted Radical Prostatectomy (Procedure)
结局指标
主要结局
Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score
时间窗: Baseline, 12 Months Post-RARP
Erectile function recovery among participants will be measured by the change in scores within the Sexual Domain of the Expanded Prostate Cancer Index Composite Short Form (EPIC26). The EPIC26 is a 26-item questionnaire used to measure health-related quality of life (HRQOL) among men with prostate cancer. The EPIC26 has five domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better HRQOL.
次要结局
- Change in Erectile Function Recovery as Measured by SHIM Score(Baseline, 12 Months Post-RARP)
- Number of Treatment-Related Adverse Events(Up to 12 months post-RARP)
- Change in Proportion of Participants with mild ED or Better as Defined by SHIM Score(Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP)
- Change in Rate of Urinary Control(Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP)
- Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score(Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP)
- Change in Proportion of Participants who Require the Use of More Invasive Erectile Aids(Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP)
- Change in Biochemical Failure(Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP)
- Change in Proportion of Participants with Erections Adequate for Penetration ≥ 50% of the time(Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP)
研究者
Sanoj Punnen, MD, MAS
Associate Professor of Clinical
University of Miami