## Protocol Section
### Identification Module
**NCT ID:** NCT06434649

**Brief Title:** 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

#### Organization Study ID Info
**ID:** FirstAHFujian-Ning Xu
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Fujian Medical University
### Status Module
#### Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Fujian Cancer Hospital

**Class:** OTHER

**Name:** Zhongshan Hospital Xiamen University

**Class:** OTHER

**Name:** Fuzhou General Hospital

**Class:** OTHER

**Name:** Longyan City First Hospital

**Class:** OTHER

**Name:** The First Hospital of Jilin University

**Class:** OTHER

**Name:** The First Affiliated Hospital of Nanchang University

**Class:** OTHER

**Name:** Ningbo No. 1 Hospital

**Class:** OTHER

**Name:** Hainan People's Hospital

**Class:** OTHER

**Name:** Second Affiliated Hospital of Third Military Medical University

**Class:** OTHER

**Name:** Zhejiang University

**Class:** OTHER

**Name:** Huashan Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Ning Xu

#### Responsible Party

**Investigator Affiliation:** First Affiliated Hospital of Fujian Medical University

**Investigator Full Name:** Ning Xu

**Investigator Title:** Head of Urology

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Surgical Procedure, Unspecified

- Prostate Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**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.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 118

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In 2010, Italian urologist Dr Bocciardi carried out the first clinical practice of separation and resection of the prostate via the vesicorectal fossa, and this new surgical procedure was called Retzius-sparing Robotic Assisted Radical Prostatectomy (RS-RARP). In recent years, the posterior approach extrafascial technique of RS-RARP which has been used to widely resect the prostate and its surrounding fascia and neurovascular bundles, compared with RS-RARP, has been proposed to provide more complete resection of the tumour and reduce the rate of positive margins. The patients are included into the posterior approach extrafascial technique group who undergo the posterior approach extrafascial technique of RS-RARP.

**Intervention Names:**

- Procedure: Extrafascial robotic assisted radical prostatectomy via posterior approach

**Label:** the posterior approach extrafascial technique group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Anterior approach extrafascial technique is the most traditional method of radical prostatectomy for prostate cancer, in which the prostate is tied ventrally to expose the prostate by cutting the deep dorsal penile vein complex and the surrounding ligaments and fascia, and intraoperatively extensive resection is required to remove the prostate and its surrounding fascia and neurovascular bundles. The patients are included into the anterior approach extrafascial technique group who undergo the anterior approach extrafascial technique robotic assisted radical prostatectomy.

**Intervention Names:**

- Procedure: Extrafascial robotic assisted radical prostatectomy via anterior approach

**Label:** the anterior approach extrafascial technique group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- the posterior approach extrafascial technique group

**Description:** Extrafascial robotic assisted radical prostatectomy via posterior approach will be applied in the intermediate or high risk patients.

**Name:** Extrafascial robotic assisted radical prostatectomy via posterior approach

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- the anterior approach extrafascial technique group

**Description:** Extrafascial robotic assisted radical prostatectomy via anterior approach will be applied in the intermediate or high risk patients.

**Name:** Extrafascial robotic assisted radical prostatectomy via anterior approach

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status

**Measure:** rate of continence

**Time Frame:** 1 week after postoperative removal of the urinary catheter

**Description:** according to International Consultation on Incontinence Questionnaire Short Form, change in voiding score from baseline period at each visit viewpoint

**Measure:** voiding score

**Time Frame:** through study completion, an average of 1 year

**Description:** according to International Index of Erectile Function, change in erectile function score from baseline period at each visit viewpoint

**Measure:** erectile function score

**Time Frame:** through study completion, an average of 1 year

#### Secondary Outcomes

**Description:** the rate of positive specimen margins after surgery

**Measure:** the rate of positive specimen margins

**Time Frame:** after surgery, , an average of 1 year

**Description:** according to EORTC QLQ-C30, quality of life scores at each visit

**Measure:** quality of life scores

**Time Frame:** through study completion, an average of 1 year

**Description:** biochemical recurrence or imaging recurrence/progression at each visit

**Measure:** biochemical recurrence or imaging recurrence/progression

**Time Frame:** through study completion, an average of 1 year

**Description:** deaths (overall survival time) at each visit

**Measure:** overall survival time

**Time Frame:** From date of randomization until date of death from any cause, an average of 5 year

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drxun@fjmu.edu.cn

**Name:** Ning Xu, Dr.

**Phone:** 13235907575

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** the First Affiliated Hospital, Fujian Medical University

**Name:** Xue-Yi Xue

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
