Trial Title:
Posterior Extra-fascial RARP in Intermediate or High Risk Prostate Cancer
NCT ID:
NCT06434649
Condition:
Surgical Procedure, Unspecified
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, 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.
Intervention:
Intervention type:
Procedure
Intervention name:
Extrafascial robotic assisted radical prostatectomy via posterior approach
Description:
Extrafascial robotic assisted radical prostatectomy via posterior approach will be
applied in the intermediate or high risk patients.
Arm group label:
the posterior approach extrafascial technique group
Intervention type:
Procedure
Intervention name:
Extrafascial robotic assisted radical prostatectomy via anterior approach
Description:
Extrafascial robotic assisted radical prostatectomy via anterior approach will be applied
in the intermediate or high risk patients.
Arm group label:
the anterior approach extrafascial technique group
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
first hospital affiliated of Fujian medical university
Address:
City:
Fuzhou
Zip:
350005
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Ning, M.D.
Start date:
July 1, 2024
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Ning Xu
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Zhongshan Hospital Xiamen University
Agency class:
Other
Collaborator:
Agency:
Fuzhou General Hospital
Agency class:
Other
Collaborator:
Agency:
Longyan City First Hospital
Agency class:
Other
Collaborator:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Nanchang University
Agency class:
Other
Collaborator:
Agency:
Ningbo No. 1 Hospital
Agency class:
Other
Collaborator:
Agency:
Hainan People's Hospital
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Third Military Medical University
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Huashan Hospital
Agency class:
Other
Source:
First Affiliated Hospital of Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06434649
