Prostate Cancer
Conditions
Keywords
Robot-assisted radical prostatectomy, urinary continence, pelvic fascia reconstruction, anterior urethral suspension
Brief summary
This is a single-center prospective cohort study enrolling 60 to 100 patients with prostate cancer treated at The Cancer Hospital of the Chinese Academy of Medical Sciences between December 2025 and July 2026, who will receive modified RARP combined with anterior urethral suspension and pelvic fascia reconstruction. The primary endpoint is the 3-month postoperative urinary continence recovery rate. Secondary endpoints include positive surgical margin rate, intraoperative blood loss, operative duration, postoperative complications, biochemical recurrence and other indicators. Standardized surgical procedures, standardized follow-up and multi-dimensional statistical analyses will be performed to clarify the functional benefits and oncological safety of this modified technique, so as to optimize surgical strategies for locally advanced prostate cancer.
Detailed description
This single-center prospective cohort study will enroll patients with localized and locally advanced prostate cancer at The Cancer Hospital of the Chinese Academy of Medical Sciences from December 2025 to July 2026. All participants will undergo modified robot-assisted radical prostatectomy combining anterior urethral suspension and pelvic fascia reconstruction. Eligible patients are aged 40-75 years with pathologically confirmed T2-T3 prostate cancer, candidates for robotic radical prostatectomy, complete clinical and imaging data, willingness to attend regular follow-up, and signed written informed consent. Exclusion criteria include prior pelvic radiotherapy or prostate surgery, severe organ dysfunction incompatible with general anesthesia, preoperative neurogenic bladder or persistent urinary incontinence, and refusal to complete the full follow-up schedule. All surgeries will be performed by the same senior urologist following standardized protocols. The core modified technique consists of anterior urethral suspension combined with pelvic fascia reconstruction to facilitate early postoperative urinary continence recovery; urinary continence is defined as using no more than one absorbent pad per day. Intraoperative blood loss and operative duration will be fully documented in real time. Patients will receive telephone follow-up at 1, 2 and 3 months postoperatively. Urinary continence status will be assessed at each contact, and serum PSA testing will be performed regularly to monitor biochemical recurrence, which is defined as sustained PSA levels exceeding 0.1 ng/mL. All perioperative and long-term postoperative complications will be documented in detail. All clinical data will be entered into a standardized electronic database for statistical analyses. The primary endpoint is the rate of urinary continence recovery at 3 months after surgery, while secondary endpoints cover the oncological safety and perioperative risks of the modified procedure. This study aims to verify whether this improved surgical technique can achieve a favorable balance between postoperative urinary functional recovery and oncological tumor control.
Interventions
PROCEDUREModified RARP Combined with Anterior Urethral Suspension and Pelvic Fascia Reconstruction
This single-arm group receives modified robot-assisted radical prostatectomy (RARP). The surgical modification includes anterior urethral suspension and pelvic fascia reconstruction during vesicourethral anastomosis, aiming to improve early urinary continence after surgery. All enrolled patients will undergo this unified modified surgical procedure, followed by routine postoperative follow-up for functional outcomes assessment.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-group prospective cohort study. All enrolled patients with localized or locally advanced prostate cancer receive a standardized surgical procedure: modified robot-assisted radical prostatectomy with anterior urethral suspension plus pelvic fascia reconstruction. No control group is established. Telephone follow-ups will be conducted at 1, 2, and 3 months postoperatively to evaluate urinary continence status and monitor biochemical recurrence.
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Pathologically confirmed prostate cancer; 2\. Scheduled to undergo modified robot-assisted radical prostatectomy; 3\. Able to complete regular postoperative follow-up and functional assessment; 4\. Voluntarily sign written informed consent.
Exclusion criteria
* 1\. Previous history of pelvic radiotherapy or prostate surgery; 2\. Severe cardiac, pulmonary, cerebrovascular, hepatic or renal dysfunction that cannot tolerate general anesthesia and surgery; 3\. Neurogenic bladder or severe preoperative urinary incontinence; 4\. Cognitive impairment making follow-up assessment impossible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early urinanry continence recovery rate | 3 consecutive months postoperatively | Urinary continence is defined as the use of no more than one absorbent pad within 24 hours. The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery. |
| Urinary continence recovery rate | 3 consecutive months postoperatively | Urinary continence is defined as the use of no more than one absorbent pad within 24 hours. The primary endpoint is the proportion of patients who achieve urinary continence for three consecutive months after modified robot-assisted radical prostatectomy, which reflects the early functional recovery of the lower urinary tract following surgery. |
Countries
China
Outcome results
None listed