Posterior Extra-fascial RARP in Intermediate or High Risk Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434649
• Other study ID #: FirstAHFujian-Ning Xu
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Ning Xu, Dr.
• Phone: 13235907575
• Email: drxun[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Surgical Procedure, Unspecified

Intervention

Procedure:
• Extrafascial 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.
• Extrafascial 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.

Locations

Country	Name	City	State
n/a

Sponsors (12)

Lead Sponsor	Collaborator
Ning Xu	Fujian Cancer Hospital, Fuzhou General Hospital, Hainan People's Hospital, Huashan Hospital, Longyan City First Hospital, Ningbo No. 1 Hospital, Second Affiliated Hospital of Third Military Medical University, The First Affiliated Hospital of Nanchang University, The First Hospital of Jilin University, Zhejiang University, Zhongshan Hospital Xiamen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	the rate of positive specimen margins	the rate of positive specimen margins after surgery	after surgery, , an average of 1 year
Secondary	quality of life scores	according to EORTC QLQ-C30, quality of life scores at each visit	through study completion, an average of 1 year
Secondary	biochemical recurrence or imaging recurrence/progression	biochemical recurrence or imaging recurrence/progression at each visit	through study completion, an average of 1 year
Secondary	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