RecruitingNot ApplicableNCT06434649

Posterior Extra-fascial RARP in Intermediate or High Risk Prostate Cancer

Application of the Extra-fascial Robot Assisted Radical Prostatectomy Via the Posterior Approach in Intermediate or High Risk Patients: a Prospective, Multicenter, Double-blind, Randomized Controlled Study


Sponsor

Ning Xu

Enrollment

118 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. It aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (RARP) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a surgical technique for prostate cancer removal using a robotic-assisted system (called posterior extra-fascial RARP), specifically in men with intermediate- or high-risk prostate cancer, to assess its effectiveness and complication rates. **You may be eligible if...** - You have been diagnosed with intermediate- or high-risk prostate cancer, confirmed by clinical evaluation - Your prostate volume is less than 80 mL - Your life expectancy is greater than 10 years - You are in good enough general health to tolerate robot-assisted surgery (confirmed by routine preoperative tests including chest CT, ECG, and echocardiogram) - You have signed the informed consent form **You may NOT be eligible if...** - Your life expectancy is less than 10 years - You have another active cancer in addition to prostate cancer - You have uncorrected bleeding disorders - You have serious health conditions (such as severe lung disease) that prevent you from safely undergoing surgery - You or your family decline radical prostate removal surgery 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

PROCEDUREExtrafascial robotic assisted radical prostatectomy via posterior approach

Extrafascial robotic assisted radical prostatectomy via posterior approach will be applied in the intermediate or high risk patients.

PROCEDUREExtrafascial robotic assisted radical prostatectomy via anterior approach

Extrafascial robotic assisted radical prostatectomy via anterior approach will be applied in the intermediate or high risk patients.


Locations(1)

first hospital affiliated of Fujian medical university

Fuzhou, Fujian, China

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NCT06434649


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