Comparing different surgical techniques for prostate cancer treatment
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).
NA · Ministry of Science and Technology of the People´s Republic of China · NCT06730243
This study is testing different surgical methods for treating prostate cancer to see which one helps patients recover their ability to control urination faster.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Ministry of Science and Technology of the People´s Republic of China (other gov) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06730243 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Retzius-sparing robot-assisted radical prostatectomy with the 'Sandwich' technique of total urethral reconstruction against standard robot-assisted radical prostatectomy and laparoscopic radical prostatectomy. A total of 300 patients with clinically localized prostate cancer will be randomly assigned to one of the three surgical techniques performed by experienced surgeons. The primary focus is on the early recovery of urinary continence, assessed through validated patient-reported outcome measures. The study aims to provide insights into the best surgical approach for improving patient outcomes post-surgery.
Who should consider this trial
Good fit: Ideal candidates are men aged 80 years or younger with histologically verified prostate cancer who are eligible for primary curative radical prostatectomy.
Not a fit: Patients with severe comorbidities, obesity, or those who have had prior malignancies or specific surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery of urinary continence for patients undergoing prostate cancer surgery.
How similar studies have performed: Previous studies have shown promising results with similar surgical techniques, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Beijing, Beijing Municipality
- National Cancer Center — Beijing, Beijing Municipality, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.