Comparing two surgical methods for bladder cancer treatment in men
A Randomized Controlled Study to Compare the Oncology Outcome and Functional Recovery of Capsule Sparing Cystectomy and Radical Cystoprostatectomy with Detaenial Sigmoid Neobladder in Men Suffering from Bladder Cancer
This study is testing two different surgical methods for treating bladder cancer in men to see which one leads to better recovery and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 20 Years and up |
| Sex | Male |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05067101 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two surgical approaches for treating bladder cancer in men: Capsule Sparing Cystectomy (CSC) and Conventional Radical Cystoprostatectomy (CRC). The CSC method aims to preserve the prostate capsule during surgery, potentially leading to better postoperative outcomes and quality of life. Patients will undergo follow-up assessments every 3 to 6 months for up to 36 months to evaluate complications, urinary function, and overall health. The study includes a detailed analysis of postoperative complications and patient-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adult males aged 20 and above with muscle invasive bladder cancer or recurrent bladder cancer that meets specific clinical criteria.
Not a fit: Patients with distant metastasis, prostate invasion, or significant preoperative health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for men undergoing treatment for bladder cancer.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult males aged 20 and above and healthy volunteers are not accepted; * Bladder carcinoma in situ、T1G3 tumor、muscle invasive bladder cancer with clinical stage of cT2-T3N0M0 (If the clinical staging before neoadjuvant therapy meets the inclusion criteria, patients who have decreased to below cT2 after neoadjuvant therapy can also choose to be included according to the patient's wishes). * Recurrent bladder cancer: recurrent NMIBC after treatment and Carcinoma in situ that does not respond to BCG vaccine treatment. * ECOG score is 0 or 1. * Voluntarily signed the informed consent. Exclusion Criteria: * Preoperative serum creatinine more than 2.26mg/dl Or 200μmol/L. * Cancer invaded prostate or urethral (confirmed by the pathology). * Patients with distant metastasis. * Abnormal PSA level, or suspected patients with unconfirmed prostate cancer . * A history of other malignant tumors within three years. * sigmoid chronic inflammation, like ulcerative colitis or intestinal tuberculosis, and so on. * Severe cardiopulmonary and liver dysfunction, combined with other serious diseases * Other conditions that have been approved by a urologist for not suitable for neobladder surgery.
Where this trial is running
Guangzhou, Guangdong
- Chunxiao Liu — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Chunxiao Liu, doctor — Southern Medical University, China
- Study coordinator: Chunxiao Liu, doctor
- Email: liuchx888@163.com
- Phone: +86 13302296795
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.