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

NCT06434649 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Extrafascial 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.

PROCEDURE

Extrafascial 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.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    collaborator OTHER_GOV
  • Zhongshan Hospital Xiamen University

    collaborator OTHER
  • Fuzhou General Hospital

    collaborator OTHER
  • Longyan City First Hospital

    collaborator OTHER
  • The First Hospital of Jilin University

    collaborator OTHER
  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER
  • Ningbo No. 1 Hospital

    collaborator OTHER
  • Hainan People's Hospital

    collaborator OTHER
  • Second Affiliated Hospital of Third Military Medical University

    collaborator OTHER
  • Zhejiang University

    collaborator OTHER
  • Huashan Hospital

    collaborator OTHER
  • Ning Xu

    lead OTHER

Principal Investigators

  • Xue-Yi Xue · the First Affiliated Hospital, Fujian Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-10-01
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06434649 on ClinicalTrials.gov