Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Potency recovery rate
研究概览
简要总结
This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.
详细描述
Multicenter enrollment of 480 patients with localized prostate cancer meeting enrollment criteria are randomized to undergo either single-port robotic extraperitoneal VIP radical prostatectomy or multi-port robotic transperitoneal bilateral intrafascial radical prostatectomy for perioperative data recording, treatment, and monitoring with 1 year follow up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 18 years ≤ age ≤ 75 years;
- •Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;.
- •Gleason Score<
- •PSA<20ng/ml.
- •Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma;
- •The patient has healthy sexual function before surgery and intention for sexual activities after surgery;
- •Physiological condition acceptable for laparoscopic surgery;
- •Willing to cooperate and complete the study follow-up and related examinations;
- •The subject or his agent voluntarily participates in this trial and signs the written informed consent;
- •The questionnaire can be completed in Chinese.
- •The patient has been informed of the trial;
排除标准
- •High-risk and non-organ localized prostate cancer (clinical stage ≥ T2c, GS ≥ 8, PSA > 20ng/ml);
- •Special type of prostate cancer， such as neuroendocrine etc.;
- •History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement;
- •Recent surgery of rectum, perianal abscess or around fistula and perineal area;
- •Patients who have undergone previous electro-prostatectomy/enucleation of the prostate;
- •Non-recurrent patients with less than 12 months of follow-up;
- •Combination of other systemic tumors;
- •had received any type of preoperative antitumor therapy;
- •Suffering from poor general condition with the presence of one of the following conditions: including severe mental disorders, cardiovascular disease, active infections, bone marrow transplantation within 3 months, or significant abnormalities in organ function;
- •Participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months;
- •Other conditions that the researchers believe may affect the experimental results or are unethical;
研究组 & 干预措施
Single-port extraperitoneal RARP
Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques
干预措施: Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques (Procedure)
Multi-port transperitoneal RARP
Multi-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques
干预措施: Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques (Procedure)
结局指标
主要结局
Potency recovery rate
时间窗: 3 months after surgery
Potency recovery rate 3 months postoperatively, based on the patient's description of whether the erection is firm enough for sexual activity or intercourse.
次要结局
- Continence recovery rate(Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively)
- Potency recovery rate(Up to 1 year, at a frequency of 1, 6, and 12 months postoperatively)
- Estimated blood loss(During operation（on an average of 90-120minutes ）)
- Number of additional ports(During operation（on an average of 90-120minutes ）)
- PSA(Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively)
- Period of hospitalization(During period of hospitalization (up to 7 days))
- Clavien-Dindo complication score(Every day during period of hospitalization (up to 7 days))
- Operative time(During operation（on an average of 90-120minutes ）)
- Period of hospitalization post surgery(Post surgery, during period of hospitalization (up to 7 days))
研究者
Ren Shancheng
Professor，Chief of Urology
Shanghai Changzheng Hospital