Clinical trial NCT06434649: Posterior Extra-fascial RARP in Intermediate or High Risk Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Procedure, Unspecified
Prostate Cancer
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Fujian Cancer Hospital
name: Zhongshan Hospital Xiamen University
name: Fuzhou General Hospital
name: Longyan City First Hospital
name: The First Hospital of Jilin University
name: The First Affiliated Hospital of Nanchang University
name: Ningbo No. 1 Hospital
name: Hainan People's Hospital
name: Second Affiliated Hospital of Third Military Medical University
name: Zhejiang University
name: Huashan Hospital
First posted: 2024-05-30
Enrollment: 118
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: rate of continence
timeFrame: 1 week after postoperative removal of the urinary catheter
measure: voiding score
timeFrame: through study completion, an average of 1 year
measure: erectile function score
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: the rate of positive specimen margins
timeFrame: after surgery, , an average of 1 year
measure: quality of life scores
timeFrame: through study completion, an average of 1 year
measure: biochemical recurrence or imaging recurrence/progression
timeFrame: through study completion, an average of 1 year
measure: overall survival time
timeFrame: From date of randomization until date of death from any cause, an average of 5 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: first hospital affiliated of Fujian medical university
state: Fujian
Study officials:
affiliation: the First Affiliated Hospital, Fujian Medical University
name: Xue-Yi Xue
role: STUDY_DIRECTOR
References: