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

NCT06434649 | Active Not Recruiting

• 1 other identifier: FirstAHFujian-Ning Xu
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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

Surgical Procedure, Unspecified; Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• rate of continence

  rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status

  1 week after postoperative removal of the urinary catheter

• voiding score

  according to International Consultation on Incontinence Questionnaire Short Form, change in voiding score from baseline period at each visit viewpoint

  through study completion, an average of 1 year

• erectile function score

  according to International Index of Erectile Function, change in erectile function score from baseline period at each visit viewpoint

  through study completion, an average of 1 year

Secondary Outcomes (4)

• the rate of positive specimen margins

  after surgery, , an average of 1 year

• quality of life scores

  through study completion, an average of 1 year

• biochemical recurrence or imaging recurrence/progression

  through study completion, an average of 1 year

• overall survival time

  From date of randomization until date of death from any cause, an average of 5 year

Study Arms (2)

the posterior approach extrafascial technique group

EXPERIMENTAL

In 2010, Italian urologist Dr Bocciardi carried out the first clinical practice of separation and resection of the prostate via the vesicorectal fossa, and this new surgical procedure was called Retzius-sparing Robotic Assisted Radical Prostatectomy (RS-RARP). In recent years, the posterior approach extrafascial technique of RS-RARP which has been used to widely resect the prostate and its surrounding fascia and neurovascular bundles, compared with RS-RARP, has been proposed to provide more complete resection of the tumour and reduce the rate of positive margins. The patients are included into the posterior approach extrafascial technique group who undergo the posterior approach extrafascial technique of RS-RARP.

Procedure: Extrafascial robotic assisted radical prostatectomy via posterior approach

the anterior approach extrafascial technique group

ACTIVE COMPARATOR

Anterior approach extrafascial technique is the most traditional method of radical prostatectomy for prostate cancer, in which the prostate is tied ventrally to expose the prostate by cutting the deep dorsal penile vein complex and the surrounding ligaments and fascia, and intraoperatively extensive resection is required to remove the prostate and its surrounding fascia and neurovascular bundles. The patients are included into the anterior approach extrafascial technique group who undergo the anterior approach extrafascial technique robotic assisted radical prostatectomy.

Procedure: Extrafascial robotic assisted radical prostatectomy via anterior approach

Interventions

Extrafascial robotic assisted radical prostatectomy via posterior approach PROCEDURE

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

the posterior approach extrafascial technique group

Extrafascial robotic assisted radical prostatectomy via anterior approach PROCEDURE

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

the anterior approach extrafascial technique group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• intermediate- and high-risk prostate cancer patients assessed by comprehensive clinical evaluation;
• prostate volume \<80 ml;
• life expectancy of patients \>10 years;
• patients sign the "informed consent";
• Routine preoperative examination has been improved (chest CT, electrocardiogram, and color Doppler echocardiography), and there is no serious basic disease. After clinical evaluation, it can tolerance robot-assisted radical prostatectomy (RARP).

You may not qualify if:

• life expectancy \<10 years;
• comorbidities with other malignancies;
• uncorrected coagulation dysfunctions;
• patients with severe underlying diseases such as severe pulmonary insufficiency who could not tolerate the surgery;
• patients or family members who did not accept radical prostatectomy.

Sponsors & Collaborators

• Fuzhou General Hospital: collaborator
• Longyan City First Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Ningbo No. 1 Hospital: collaborator
• Hainan People's Hospital: collaborator
• Zhejiang University: collaborator
• Huashan Hospital: collaborator
• Ning Xu: lead
• Fujian Cancer Hospital: collaborator
• Zhongshan Hospital Xiamen University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Second Affiliated Hospital of Third Military Medical University: collaborator

Study Sites (1)

first hospital affiliated of Fujian medical university

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Xue-Yi Xue

  the First Affiliated Hospital, Fujian Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind technique will be used in this study. The blinding process will be done by a statistician unrelated to this clinical trial. Treatment group assignment will not be known to the subject or to the study followers or to the investigator who clinically evaluates the subject for the entire duration of the trial. Allocation concealment was achieved in this study through an interactive response system. In the absence of serious complications or other emergencies in the subjects during the study period, normal procedures were followed for revealing blinding, this study provides for the use of secondary blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Urology

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 30, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)