Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fujian Cancer Hospital | OTHER_GOV |
| Zhongshan Hospital Xiamen University | OTHER |
| Fuzhou General Hospital | OTHER |
| Longyan City First Hospital |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the posterior approach extrafascial technique group | Experimental | 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. |
|
| the anterior approach extrafascial technique group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extrafascial robotic assisted radical prostatectomy via posterior approach | Procedure | Extrafascial robotic assisted radical prostatectomy via posterior approach will be applied in the intermediate or high risk patients. |
| Measure | Description | Time Frame |
|---|---|---|
| rate of continence | rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status | 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 | 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 | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of positive specimen margins | the rate of positive specimen margins after surgery | after surgery, , an average of 1 year |
| quality of life scores | according to EORTC QLQ-C30, quality of life scores at each visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xue-Yi Xue | the First Affiliated Hospital, Fujian Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| first hospital affiliated of Fujian medical university | Fuzhou | Fujian | 350005 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| The First Hospital of Jilin University | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| Ningbo No. 1 Hospital | OTHER |
| Hainan People's Hospital | OTHER |
| Second Affiliated Hospital of Third Military Medical University | OTHER |
| Zhejiang University | OTHER |
| Huashan Hospital | OTHER |
Not provided
Not provided
Not provided
Double-blind technique will be used in this study. The blinding process will be done by a statistician unrelated to this clinical trial. Treatment group assignment will not be known to the subject or to the study followers or to the investigator who clinically evaluates the subject for the entire duration of the trial. Allocation concealment was achieved in this study through an interactive response system. In the absence of serious complications or other emergencies in the subjects during the study period, normal procedures were followed for revealing blinding, this study provides for the use of secondary blinding.
| Extrafascial robotic assisted radical prostatectomy via anterior approach | Procedure | Extrafascial robotic assisted radical prostatectomy via anterior approach will be applied in the intermediate or high risk patients. |
|
| through study completion, an average of 1 year |
| biochemical recurrence or imaging recurrence/progression | biochemical recurrence or imaging recurrence/progression at each visit | through study completion, an average of 1 year |
| overall survival time | deaths (overall survival time) at each visit | From date of randomization until date of death from any cause, an average of 5 year |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided