Total en Bloc Urethra Preservation at Robot-assisted Prostatectomy (ToP-RAP): A Prospective IDEAL Stage 2a Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Technical feasibility of ToP-RAP
研究概览
简要总结
Prospective single-arm IDEAL stage 2a feasibility study of urethra-preserving RARP in localized prostate cancer.
详细描述
Our study introduces a urethra-preserving prostatectomy concept that maintains the entire intraprostatic urethra, thereby avoiding both urethral transection and vesicourethral anastomosis. We embed the technique in a transparent IDEAL-based framework with predefined intra-operative decision rules, including prespecified conversion to standard robot-assisted radical prostatectomy. This positions the technique as a distinct step beyond existing bladder neck- or urethra-sparing modifications, and provides the first prospective multicentre data supporting its feasibility in selected patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Life expectancy >=10 years (biological age)
- •No prior prostate therapy (laser enucleation, TURP, focal therapy)
- •No pelvic/prostate radiotherapy;
- •No prior abdominal/rectal surgery;
- •No prior (neoadjuvant) androgen-deprivation therapy
- •No prior stroke/cerebral ischemia with neurological sequelae;
- •No neurological disease (e.g., Parkinson's)
- •Transrectal or transperineal bilateral biopsy >=12 cores (MRI-ultrasound fusion, targeted + systematic)
- •PSA <=15 ng/mL; prostate volume <=80 mL
- •Biopsy ISUP grade 1-3 (= Gleason 3+3 / 3+4 / 4+3)
- •No Gleason pattern 5; no intraductal, cribriform or neuroendocrine carcinoma
- •mp/bpMRI (mandatory if biopsy Gleason >=3+4)
- •No suspected metastases at staging
排除标准
- •- Failure to meet any inclusion criterion, or patient declining ToP-RAP (offered standard RARP per EAU guidelines)
结局指标
主要结局
Technical feasibility of ToP-RAP
时间窗: Intraoperative (day of surgery)
Proportion of enrolled patients in whom ToP-RAP is completed per the pre-specified technical standards without intraoperative conversion to standard RARP.
Perioperative safety (Clavien-Dindo)
时间窗: Up to 90 days after surgery
Rate and maximum grade of intra- and post-operative complications classified by the Clavien-Dindo system.
Time to urinary continence recovery
时间窗: Up to 12 months after surgery
Days from surgery to urinary continence recovery defined as use of 0 or 1 safety pad per day. Inpatient continence is defined by Stamey criteria (medical expert assessment).
次要结局
- PSA persistence and biochemical recurrence(3, 6, 9, 12 and 24 months after surgery)
- Erectile function recovery(Up to 24 months after surgery)
研究者
Sami-Ramzi Leyh-Bannurah
Principal Investigator
Jung Stilling Hospital