Comparison of the Integrated Posterior-Anterior-Lateral Approach and the Posterior Approach in Robotic Radical Prostatectomy

NCT07305142 | Completed

• 1 other identifier: 2024-KY-0820-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare perioperative, pathological, and early functional outcomes of PAL （Posterior, Anterior and Lateral）combined approach RARP and posterior approach (with Retzius space preserved) RARP in the treatment of prostate cancer.The main question it aims to answer was: What is the early therapeutic efficacy of robot-assisted laparoscopic radical prostatectomy using the combined posterior, anterior, and lateral (PAL) approach, and how does it compare with the traditional posterior approach? Participants were randomly assigned to undergo either robot-assisted laparoscopic radical prostatectomy using the PAL (posterior-anterior-lateral) approach or the classic posterior approach.

Conditions

Urologic Cancer; Prostate; Robot Assisted Laparoscopic Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• urinary continence

  was defined as the use of zero to one safety pad per day without any involuntary leakage.Immediate continence was defined as continence within seven days after catheter removal, while early continence was defined as continence achieved within three months.

  Patients were assessed for urinary incontinence, defined according to established criteria, via telephone at five time points after the removal of the urinary catheter (which was 2-3 weeks post-surgery): within 7 days, and at 1, 3, 6, and 12 months.

Secondary Outcomes (4)

• Operation time

  During operation

• Estimated blood loss

  During operation

• Complications

  Perioperative

• Time for removal of drainage tube

  Perioperative

Study Arms (2)

PAL-RAPA

ACTIVE COMPARATOR

Participants undergo robot-assisted laparoscopic radical prostatectomy(RAPA) via an integrated Posterior-Anterior-Lateral (PAL) approach using the da Vinci system. * Posterior:\*\* mobilize sigmoid colon, incise rectovesical peritoneum, dissect vas deferens and seminal vesicles, open Denonvilliers' fascia, create a fascial window at prostate base. * Anterior:\*\* enter retropubic space, preserve endopelvic fascia, puboprostatic ligaments, dorsal venous complex, expose bladder neck and anterior prostate. * Lateral:\*\* dissect lateral bladder neck/prostate base, expand triangular space, retract seminal vesicle through posterior window, incise bladder neck, control vascular pedicles, perform atraumatic neurovascular bundle dissection, preserve urethral length. * Prostate removal\*\* is followed by \*\*continuous urethrovesical anastomosis\*\* with 3-0 barbed suture. \*\*Intended Purpose of Intervention:\*\* Assess perioperative outcomes, early functional recovery, and oncologic safety of PAL-RAPA

Procedure: PAL combined approach group

Posterior RAPA

ACTIVE COMPARATOR

Participants undergo robot-assisted laparoscopic radical prostatectomy via a posterior-only approach using the da Vinci system. The procedure includes: mobilization of the sigmoid colon, incision of the rectovesical peritoneum, dissection of vas deferens and seminal vesicles, opening of Denonvilliers' fascia, and creation of a fascial window at the prostate base. Prostate removal is followed by continuous urethrovesical anastomosis using a 3-0 barbed suture.

Procedure: posterior approach group

Interventions

PAL combined approach group PROCEDURE

PAL combined approach was performed to resect the prostate

PAL-RAPA

posterior approach group PROCEDURE

Intraoperative resection of the prostate was performed by posterior approach

Posterior RAPA

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate biopsy confirms prostate cancer;
• Clinical T stage \<=T3a stage;
• Fully understand clinical trial protocols and sign informed consent;

You may not qualify if:

• Urinary incontinence before surgery;
• Previous endoscopic prostate surgery;
• There are serious underlying diseases that cannot tolerate surgery or have a survival of less than 5 years;
• Metastatic disease is present or lymph node involvement is suspected at diagnosis;
• Patients judged by the investigator to be unsuitable for participation in this clinical trial;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urology

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 26, 2025
• Study Start: May 16, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 2, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after the completion of the research

Locations

CN (1)