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Recruiting NCT06977906

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

No phase Interventional Robotic-Assisted Radical Prostatectomy Locally Advanced Prostate Cancer Bladder Suspension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: conventional Robotic-assisted radical prostatectomy group, Improved Robotic-assisted radical prostatectomy group.
Who it may be relevant to
Registry conditions: Robotic-Assisted Radical Prostatectomy, Locally Advanced Prostate Cancer, Bladder Suspension. Basic parameters: No limits · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure conventional Robotic-assisted radical prostatectomy group
    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 b
  • Procedure Improved Robotic-assisted radical prostatectomy group
    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 anter

Primary outcome measures

  • rate of continence [Time frame: 1 week, 1 month and 3 month after postoperative removal of the urinary catheter]
  • The degree of bladder descent [Time frame: 1 month after operation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • first hospital affiliated of Fujian medical university — Fuzhou

Identifiers

NCT: NCT06977906 · MRCTA,ECFAH of FMU [2025]546

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗