A Prospective, Multi-center, Real-world Study on the Comparison of Different Nerve-sparing Techniques in Retzius-sparing Robot-assisted Radical Prostatectomy for Oncological Outcome and Functional Recovery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- biochemical recurrence-free rates
研究概览
简要总结
To evaluate the difference among three nerve-sparing techniques(unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection) of oncological outcome and functional recovery.
详细描述
Surgery is a common and effective treatment for localized prostate cancer. The main objective of surgical treatment is to remove the tumor completely in order to achieve the goal of cure. Intrafascial nerve-sparing radical prostatectomy is a radical resection of prostate cancer with minimal damage to the nerves and blood vessels.
There are nerves around the prostate that affect sexual function, and damage to these nerves can lead to complications like sexual dysfunction and incontinence. Therefore, how to completely remove the tumor, as far as possible to preserve these nerves, become an important issue in the surgical treatment.
This study is aim to evaluate the different among nerve-sparing strategies, including unilateral intrafascial resection, bilateral intrafascial resection and bilateral extrafascial resection, on oncological outcome and functional recovery, so as to provide clinical evidence for nerve-sparing surgery of prostate cancer via robot-assisted posterior approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged ≥18 years and ≤80 years;
- •Histologically proven prostate adenocarcinoma with clinical stage < T3(no capsule break)
- •Clinically localized prostate cancer in very low, low, or intermediate risk groups according to National Comprehensive Cancer Network(NCCN) guidelines (2019 v4) ;
- •Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;
- •Life expectancy greater than 10 years;
- •Patients who are willing to accept robot-assisted radical prostatectomy after informed existing treatment plan, must sign the informed consent form.
排除标准
- •Surgeon thinks that the patient has an unresectable disease;
- •patients who have already applied androgen deprivation therapy(ADT);
- •Preoperative images suggest that the local lymph nodes were larger than 2 cm or suggest bone or distant metastasis;
- •Any contraindication;
- •Previous treatment of prostate cancer, including but not limited to surgery, hormone therapy, chemotherapy, radiotherapy, targeted therapy and immunotherapy;
- •Patients with a history of transurethral resection or enucleation of the prostate;
- •Severe systemic disease that may interfere with the data, assessment, or compliance;
- •Patients who are participating in other clinical trials;
- •Refusing to sign the informed consent
- •Patients that are considered to be not suitable to be included by the researchers.
结局指标
主要结局
biochemical recurrence-free rates
时间窗: 3 years
the rate of patients who do not have biochemical recurrence
urinary control rate
时间窗: day 0, 3 month, 6 month, 1 year
the rate of patients who do not have incontinence
sexual function
时间窗: 6 month, 1 year
the rate of patients who do not lose sexual function
次要结局
- prostate cancer-specific survival(3 years)
- perioperative complications(perioperation)
- positive rate of incisal margin(day 0)