RecruitingNot ApplicableNCT06238713

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


Sponsor

Shanghai Changzheng Hospital

Enrollment

480 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: MALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches for robotic-assisted radical prostatectomy — the complete surgical removal of the prostate — in men with early-stage prostate cancer. One approach goes through the space outside the abdominal cavity using a single port, and the other goes through the abdominal cavity using multiple ports. Researchers want to compare recovery, complications, and sexual function outcomes. **You may be eligible if...** - You are a man between 18 and 75 years old - You have been diagnosed with early-stage (organ-confined) prostate cancer - Your PSA level is below 20 ng/mL and your Gleason score is less than 8 - You had a biopsy within the past 6 months confirming the diagnosis - You had normal sexual function before your diagnosis and wish to preserve it - You can read and complete questionnaires in Chinese **You may NOT be eligible if...** - Your cancer is high-risk or has spread outside the prostate - You have had prior prostate or abdominal surgery or pelvic radiation - Your general health status is poor (ECOG greater than 1) - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESingle-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy(VIP) techniques

Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy(VIP) techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.

PROCEDUREMulti-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques

Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.


Locations(1)

Changzheng hospital

Shanghai, Shanghai Municipality, China

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NCT06238713


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