Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434649
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-10
Brief Title:
Posterior Extra-fascial RARP in Intermediate or High Risk Prostate Cancer
Sponsor:
Ning Xu
Organization:
First Affiliated Hospital of Fujian Medical University
Study Overview
Official Title:
Application of the Extra-fascial Robot Assisted Radical Prostatectomy Via the Posterior Approach in Intermediate or High Risk Patients a Prospective Multicenter Double-blind Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 142 1 month visit 3 day 285 3 months visit 4 day 907 6 months visit 5 day 1807 and 12 months visit 6 day 36014 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 PETCT 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
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 11 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 142 1 month visit 3 day 285 3 months visit 4 day 907 6 months visit 5 day 1807 and 12 months visit 6 day 36014 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 PETCT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None