Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction Versus Standard Robot-Assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy Surgery: A Comparative Prospective Study of 300 Patients

NCT06730243 | Recruiting

• 1 other identifier: 24/048-4328
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the impact of Retzius-sparing robot-assisted radical prostatectomy with "Sandwich" Technique of Total Urethral Reconstruction on early recovery of urinary continence (UC) compared to the conventional approach (anterior approach) and Laparoscopic Radical Prostatectomy for the treatment of clinically localized prostate cancer (PCa).Purpose: The trial compares outcomes between three groups.

Conditions

Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction

Outcome Measures

Primary Outcomes (1)

• immediate urinary continence analysis

  Primary outcome was UC (defined as 0 pads/one security liner per day) after catheter removal

  1day，1month, 3 months after removal of the urinary cathete

Study Arms (3)

RS-RARP-S

EXPERIMENTAL

Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction

Procedure: Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction

S-RARP

EXPERIMENTAL

Standard RARP

Procedure: Standard Robot-Assisted Radical Prostatectomy

LRP

SHAM COMPARATOR

Laparoscopic Radical Prostatectomy

Procedure: Laparoscopic Radical Prostatectomy

Interventions

Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction PROCEDURE

Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction

RS-RARP-S

Standard Robot-Assisted Radical Prostatectomy PROCEDURE

Standard Robot-Assisted Radical Prostatectomy

S-RARP

Laparoscopic Radical Prostatectomy PROCEDURE

Laparoscopic Radical Prostatectomy

LRP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological verified prostate carcinoma (first diagnosis) Indication for primary curative radical prostatectomy Age ≤80 years Patient agrees to randomisation Patient is able to fill in the questionnaires on his own Patient is willing to provide written informed consent

You may not qualify if:

• Insufficient knowledge of German Severe cognitive impairment Obesity (BMI \> 35) Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy or relapse of every kind) Tumor stage: T4 Previous malignancy (≤ 3 years before trial participation) Neoadjuvant therapy (hormons) within the last 3 months before participation in the trial Patient is immuno-compromised History of intermittent urinary self-catheterization within the last year Psychological disorders (dementia, chronic depression, psychosis) Any of the following treatments ≤ 3 months before trial participation: surgery of the sigmoid colon, extended haemorrhoid resection, transurethral needle ablation of the prostate (TUNA), osteosynthesis of the pelvis, salvage prostatectomy Patients with chronic urinary infection Dialysis patients Lacking willingness for data storage and handling in the frame of the trial protocol/aims

Sponsors & Collaborators

• Ministry of Science and Technology of the People´s Republic of China: lead

Study Sites (1)

National Cancer Center

Beijing, Beijing Municipality, 100021, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Cancer Center

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 12, 2024
• Study Start: January 1, 2023
• Primary Completion: December 10, 2024
• Study Completion: January 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)