A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
研究概览
简要总结
The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy.
详细描述
Subjects will be randomized in a 1:1 ratio to Retzius nerve sparing versus non-Retzius nerve sparing to compare cancer outcomes and urinary/sexual outcomes following radical prostatectomy. Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.
The investigators will assess recovery of urinary and sexual function of patients through questionnaires at 1 week, 1 month, 6 months, 12 months, and 24 months 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
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •clinically localized prostate cancer
- •able to read and speak English or Spanish
- •no previous history of head injury, dementia or psychiatric illness
- •no other concurrent cancer
- •estimated life expectancy of 10 years or more
- •biopsy proven prostate cancer
排除标准
- •evidence of metastases
- •Prostate specific antigen (PSA) greater than 30 ng/mL
- •previous major pelvic surgery
- •diagnosis of another malignancy within the past 5 years, with the exception of non-melanoma skin cancer
结局指标
主要结局
Number of Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
时间窗: Up to 24 months following surgery
The investigators will obtain patient-reported complications and adverse events captured from patient's medical record.
Change in Patient-reported Health-Related Quality of Life (HRQOL) Scores as Assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
时间窗: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
Patients will fill out the EPIC-CP questionnaire. The EPIC-CP is a 10-item questionnaire assessing five health-related quality of life domains: urinary function, urinary irritation, bowel function, sexual function, and hormonal issues. All questions are about patients' health and symptoms in the last four weeks. Each domain is scored out of 12 points, with higher scores indicating more complications. In total, the EPIC-CP score is the final sum of the 5 domains. The EPIC-CP is scored out of 60 points, with higher scores indicating more issues related to overall prostate cancer quality of life.
Change from Baseline in Prostate Specific Antigen (PSA) value on Laboratory Reports up to 24 Months Following Surgery
时间窗: Baseline and up to 24 months post-surgery
The investigators will obtain patient's PSA values from their medical record, at baseline and up to 24 months post-surgery. Patient PSA levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.
次要结局
- Change in Baseline in Patient-Reported Penile Deformity as Assessed on Questionnaire(Baseline, 6 months, 12 months, and 24 months post-surgery)
- Change in Patient-reported Treatment Regret Scores as Assessed by Questionnaire(12 months, 24 months post-surgery)
- Change in Baseline in Patient-Reported Penile Shortening as Assessed on Questionnaire(Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery)