An interventional study of Extrafascial robotic assisted radical prostatectomy via posterior approach and Extrafascial robotic assisted radical prostatectomy via anterior approach in Surgical Procedure, Unspecified and Prostate Cancer, sponsored by Ning Xu. Active, not recruiting at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Ning Xu · Not applicable, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.
This study's planned enrollment of 118 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
In 2010, Italian urologist Dr Bocciardi carried out the first clinical practice of separation and resection of the prostate via the vesicorectal fossa, and this new surgical procedure was called Retzius-sparing Robotic Assisted Radical Prostatectomy (RS-RARP). In recent years, the posterior approach extrafascial technique of RS-RARP which has been used to widely resect the prostate and its surrounding fascia and neurovascular bundles, compared with RS-RARP, has been proposed to provide more complete resection of the tumour and reduce the rate of positive margins. The patients are included into the posterior approach extrafascial technique group who undergo the posterior approach extrafascial technique of RS-RARP.
Procedure: Extrafascial robotic assisted radical prostatectomy via posterior approach
Anterior approach extrafascial technique is the most traditional method of radical prostatectomy for prostate cancer, in which the prostate is tied ventrally to expose the prostate by cutting the deep dorsal penile vein complex and the surrounding ligaments and fascia, and intraoperatively extensive resection is required to remove the prostate and its surrounding fascia and neurovascular bundles. The patients are included into the anterior approach extrafascial technique group who undergo the anterior approach extrafascial technique robotic assisted radical prostatectomy.
Procedure: Extrafascial robotic assisted radical prostatectomy via anterior approach
Extrafascial robotic assisted radical prostatectomy via posterior approach will be applied in the intermediate or high risk patients.
Extrafascial robotic assisted radical prostatectomy via anterior approach will be applied in the intermediate or high risk patients.
rate of continence
rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status
Time frame: 1 week after postoperative removal of the urinary catheter
voiding score
according to International Consultation on Incontinence Questionnaire Short Form, change in voiding score from baseline period at each visit viewpoint
Time frame: through study completion, an average of 1 year
erectile function score
according to International Index of Erectile Function, change in erectile function score from baseline period at each visit viewpoint
Time frame: through study completion, an average of 1 year
the rate of positive specimen margins
the rate of positive specimen margins after surgery
Time frame: after surgery, , an average of 1 year
quality of life scores
according to EORTC QLQ-C30, quality of life scores at each visit
Time frame: through study completion, an average of 1 year
biochemical recurrence or imaging recurrence/progression
biochemical recurrence or imaging recurrence/progression at each visit
Time frame: through study completion, an average of 1 year
overall survival time
deaths (overall survival time) at each visit
Time frame: From date of randomization until date of death from any cause, an average of 5 year
Plan to share: No
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This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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