About this trial
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.
Eligibility criteria
Qualifiers
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<8.
PSA<20ng/ml.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy(VIP) techniques
- Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
Treatment groups
Sponsors and collaborators
Shanghai Changzheng Hospital
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
ShuGuang Hospital
Collaborator
Eastern Hepatobiliary Surgery Hospital
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Sichuan Provincial People's Hospital
Collaborator