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NCT06977906 | RECRUITING | Robotic-Assisted Radical Prostatectomy

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

First Affiliated Hospital of Fujian Medical University

Brief Summary:

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.

Condition or disease

Robotic-Assisted Radical Prostatectomy

Locally Advanced Prostate Cancer

Bladder Suspension

Intervention/treatment

conventional Robotic-assisted radical prostatectomy group

Improved Robotic-assisted radical prostatectomy group

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Improved Robotic-Assisted Radical Prostatectomy for Locally Advanced Prostate Cancer: Bladder Suspension and Preliminary Outcomes
Actual Study Start Date : 2024-01-01
Estimated Primary Completion Date : 2027-01-01
Estimated Study Completion Date : 2027-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. 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
  • 2. multiparametric MRI (mpMRI) with a 3.0 T scanner for prostate or pelvic scans performed within 30 days before the operation at our center
  • 3. Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 1
  • 4. Complete clinical and prostate biopsy pathological data.
  • 5. General health is good, with no infections, autoimmune diseases, hematologic disorders, or other malignancies.
Exclusion Criteria
  • 1. Presence of surgical contraindications.
  • 2. refusal of enhanced mpMRI imaging.
Improved Robotic-Assisted Radical Prostatectomy for Locally Advanced Prostate Cancer: Bladder Suspension and Preliminary Outcomes

Location Details

NCT06977906

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How to Participate

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Locations

RECRUITING

China, Fujian

first hospital affiliated of Fujian medical university

F U axis, Fujian, China, 350005