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NCT Number: NCT06977906

Improved Robotic-Assisted Radical Prostatectomy for Locally Advanced Prostate Cancer: Bladder Suspension and Preliminary Outcomes

This study is a prospective, single-center clinical trial. It aims to establish an improved robotic-assisted radical prostatectomy for treating locally advanced prostate cancer. The technique evaluates the impact of preserving the anterior peritoneum of the bladder on postoperative bladder descent and urinary control recovery. A retrospective analysis compares this modified approach with traditional anterior approach surgery, assessing differences in oncological outcomes, early functional recovery, and postoperative complication rates. The goal is to provide new theoretical foundations and technical support for the prevention and treatment of postoperative urinary incontinence.

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

first hospital affiliated of Fujian medical university

Fuzhou, Fujian, 350005, China

Location status: Recruiting

Location contact

Ning

CONTACT

Xu Ning

CONTACT

[email protected]

+8613235907575

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • prostate biopsy and clinical confirmation of high-risk prostate cancer (PSA > 20 ng/mL, Gleason score ≥ 8, or cT stage ≥ T2c) followed by robotic-assisted radical prostatectomy
  • multiparametric MRI (mpMRI) with a 3.0 T scanner for prostate or pelvic scans performed within 30 days before the operation at our center
  • Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 1
  • Complete clinical and prostate biopsy pathological data.
  • General health is good, with no infections, autoimmune diseases, hematologic disorders, or other malignancies.

Exclusion criteria

  • Presence of surgical contraindications.
  • refusal of enhanced mpMRI imaging.

Treatment and study plan

conventional Robotic-assisted radical prostatectomy group

Procedure

Robotic-assisted radical prostatectomy uses a standard anterior approach with transabdominal or extraperitoneal access. After establishing pneumoperitoneum, the Retzius space is dissected to expose the prostate. The deep dorsal venous complex is ligated to control bleeding, and the bladder neck is carefully dissected while preserving the ureters. Seminal vesicles, vas deferens, and neurovascular bundles are selectively preserved based on tumor characteristics. A tension-free anastomosis of the bladder and urethra is performed using absorbable sutures. Lymph node dissection is done if necessary. The robotic system ensures precise dissection, hemostasis, and suturing, optimizing oncological control while preserving urinary continence and sexual function with reduced bleeding and complications.

Improved Robotic-assisted radical prostatectomy group

Procedure

The procedure is performed in a head-down, feet-up supine position with an abdominal or extraperitoneal approach. The right peritoneum is opened along the right external iliac vein to clear the obturator nerve, vessels, and lymph nodes. The external and internal iliac lymph nodes are also cleared. The right pelvic fascia is incised to remove prostate fat while preserving the bladder's anterior wall peritoneum. The same approach is used on the left side. The peritoneum is retracted to clear anterior prostate fat, and the deep venous complex is ligated to expose the prostate. Prostatectomy is performed, followed by urethra and bladder anastomosis, and peritoneal suturing with drainage tube placement.

Primary outcomes

  1. rate of continence

    Time frame: 1 week, 1 month and 3 month after postoperative removal of the urinary catheter

    Time Frame:1 week, 1 month and 3 month after postoperative removal of the urinary catheter

  2. The degree of bladder descent

    Time frame: 1 month after operation

    Time Frame:1 month after operation

Study contacts

Contact information is provided by the study sponsor or research team.

Xu Ning, Dr.

CONTACT

[email protected]

+8613235907575

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 18, 2025
Registry last updated
May 18, 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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