Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-75
SponsorShanghai Changzheng Hospital

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

480 Participants
are divided into 2 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