posterior extra-fascial rarp in intermediate or high risk prostate cancer

Conditions: Surgical Procedure, Unspecified; Prostate Cancer

Summary: this study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. it aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (rarp) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients.

this study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. it aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (rarp) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients. about 118 subjects will be enrolled in this study in a total of 12 research centres across the country, and eligible subjects will be randomly assigned to the posterior approach extrafascial technique group and the anterior approach extrafascial technique group in a 1:1 ratio. all subjects routinely underwent comprehensive and systematic physical examination, laboratory tests and imaging examinations before surgery. after surgery, subjects were followed up at 1 week (visit 2, day 14±2), 1 month (visit 3, day 28±5), 3 months (visit 4, day 90±7), 6 months (visit 5, day 180±7), and 12 months (visit 6, day 360±14) after removal of the urinary catheter after the surgery, and then annually thereafter (visit 7), with urine control rate (defined as 0/ 1 pad) and 24-h pad weight questionnaires, psa examination, international prostate symptom score (ipss), international consultation on incontinence questionnaire short form (ici-qsf), international index of erectile function (iief), and related scores such as general health-related quality of life (eortc qlq-c30) and prostate cancer-specific quality of life (qlq-pr25). ) and other relevant scores; in case of clinical suspicion of local recurrence, imaging (pelvic mri), whole-body bone imaging in patients with bone pain, and whole-body pet/ct if necessary. subjects will be monitored and evaluated for adverse events (ae) throughout the trial. subjects will participate in the clinical trial for an expected duration of approximately 1 year, after which they will be followed up periodically according to the usual follow-up strategy.

Eligibility criteria:
inclusion criteria: 1. intermediate- and high-risk prostate cancer patients assessed by comprehensive clinical evaluation; 2. prostate volume \<80 ml; 3. life expectancy of patients \>10 years; 4. patients sign the "informed consent"; 5. routine preoperative examination has been improved (chest ct, electrocardiogram, and color doppler echocardiography), and there is no serious basic disease. after clinical evaluation, it can tolerance robot-assisted radical prostatectomy (rarp). exclusion criteria: 1. life expectancy \<10 years; 2. comorbidities with other malignancies; 3. uncorrected coagulation dysfunctions; 4. patients with severe underlying diseases such as severe pulmonary insufficiency who could not tolerate the surgery; 5. patients or family members who did not accept radical prostatectomy.