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

Fujian Medical University (FJMU)

Status: Enrolling

Conditions: Bladder Suspension; Locally Advanced Prostate Cancer; Robotic-Assisted Radical Prostatectomy

Treatments: Procedure: Improved Robotic-assisted radical prostatectomy group; Procedure: conventional Robotic-assisted radical prostatectomy group

Study type: Interventional

Funder types: Other

Identifiers

NCT06977906

MRCTA,ECFAH of FMU [2025]546

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

conventional Robotic Assisted Radical Prostatectomy group

Active Comparator group

Description:

The conventional RARP utilizes a traditional anterior approach through the patient's head-down, feet-up supine position, with either transabdominal or extraperitoneal access. After establishing pneumoperitoneum, precise dissection of the Retzius space is performed to expose the prostate and surrounding structures. The deep dorsal venous complex is pre-emptively ligated to control bleeding, followed by sharp dissection of the bladder neck while preserving the ureteral orifices. The seminal vesicles and vas deferens are then mobilized, with selective preservation of the neurovascular bundles based on the tumor's characteristics to maintain erectile function. The prostate apex and urethra are delicately dissected while protecting the sphincter, and after complete prostate removal, a continuous, tension-free anastomosis of the bladder and urethra is performed using absorbable sutures. Lymph node dissection is carried out if necessary. Throughout the procedure

Treatment:

Procedure: Improved Robotic-assisted radical prostatectomy group

Improved Robotic-Assisted Radical Prostatectomy group

Experimental group

Description:

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.

Treatment:

Procedure: conventional Robotic-assisted radical prostatectomy group