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Completed

NCT Number: NCT07305142

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

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.

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Key information

Conditions

Urologic Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Robot Assisted Laparoscopic Radical Prostatectomy Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;

Treatment and study plan

PAL combined approach group

Procedure

PAL combined approach was performed to resect the prostate

posterior approach group

Procedure

Intraoperative resection of the prostate was performed by posterior approach

Primary outcomes

  1. urinary continence

    Time frame: 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.

    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.

Secondary outcomes

  1. Operation time

    Time frame: During operation

  2. Estimated blood loss

    Time frame: During operation

  3. Complications

    Time frame: Perioperative

    Complications were classified according to the Clavien-Dindo system, and those of grade II or higher were documented in this study.

  4. Time for removal of drainage tube

    Time frame: Perioperative

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Registry information

Official study title

A Prospective, Randomized Controlled Study Comparing the Integrated Posterior-Anterior-Lateral (PAL) Approach and the Posterior Approach in Robot-Assisted Radical Prostatectomy: Evaluation of Perioperative Outcomes, Postoperative Functional Recovery, and Oncologic Control

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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