Comparing two surgical techniques for prostate cancer treatment
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
This study is testing two different surgical techniques for treating prostate cancer to see which one is safer and more effective for patients at higher risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06434649 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the feasibility and safety of two different extrafascial techniques in robot-assisted radical prostatectomy (RARP) for patients with intermediate- and high-risk prostate cancer. It is a prospective, multicentre, double-blind, randomised controlled trial involving approximately 118 subjects across 12 research centres. Participants will be randomly assigned to either the posterior or anterior approach and will undergo comprehensive preoperative evaluations. Follow-up assessments will track oncological and functional outcomes, as well as safety over a period of one year.
Who should consider this trial
Good fit: Ideal candidates are men diagnosed with intermediate- or high-risk prostate cancer who meet specific health criteria.
Not a fit: Patients with a life expectancy of less than 10 years or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence-based guidance for selecting the most effective surgical approach for prostate cancer patients.
How similar studies have performed: While similar surgical techniques have been explored, this specific comparison of posterior versus anterior approaches in RARP is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fuzhou, Fujian
- first hospital affiliated of Fujian medical university — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Ning Xu, Dr.
- Email: drxun@fjmu.edu.cn
- Phone: 13235907575
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.