Prostate Cancer, Surgical Procedure, Unspecified
Conditions
Brief 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.
Detailed description
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.
Interventions
PROCEDUREExtrafascial robotic assisted radical prostatectomy via posterior approach
Extrafascial robotic assisted radical prostatectomy via posterior approach will be applied in the intermediate or high risk patients.
PROCEDUREExtrafascial robotic assisted radical prostatectomy via anterior approach
Extrafascial robotic assisted radical prostatectomy via anterior approach will be applied in the intermediate or high risk patients.
Sponsors
Ning Xu
Fujian Cancer Hospital
Zhongshan Hospital Xiamen University
Fuzhou General Hospital
Longyan City First Hospital
The First Hospital of Jilin University
The First Affiliated Hospital of Nanchang University
Ningbo No. 1 Hospital
Hainan People's Hospital
Second Affiliated Hospital of Third Military Medical University
Zhejiang University
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of continence | 1 week after postoperative removal of the urinary catheter | rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status |
| voiding score | through study completion, an average of 1 year | according to International Consultation on Incontinence Questionnaire Short Form, change in voiding score from baseline period at each visit viewpoint |
| erectile function score | through study completion, an average of 1 year | according to International Index of Erectile Function, change in erectile function score from baseline period at each visit viewpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the rate of positive specimen margins | after surgery, , an average of 1 year | the rate of positive specimen margins after surgery |
| quality of life scores | through study completion, an average of 1 year | according to EORTC QLQ-C30, quality of life scores at each visit |
| biochemical recurrence or imaging recurrence/progression | through study completion, an average of 1 year | biochemical recurrence or imaging recurrence/progression at each visit |
| overall survival time | From date of randomization until date of death from any cause, an average of 5 year | deaths (overall survival time) at each visit |
Countries
China
Contacts
STUDY_DIRECTORXue-Yi Xue
the First Affiliated Hospital, Fujian Medical University
Outcome results
None listed