Cystoscopy and Systematic Bladder Tissue Sampling in Predicting pT0 Bladder Cancer: A Prospective Trial

Area of Science:

• Urology
• Oncology
• Pathology

Background:

• Clinical staging and final pathology discordance is a concern for patients undergoing radical cystectomy.
• Accurate assessment of bladder cancer stage is crucial for treatment decisions, including bladder preservation strategies.

Purpose of the Study:

• To prospectively investigate the reliability and shortcomings of cystoscopic evaluation in predicting pT0 bladder cancer in candidates for radical cystectomy.
• To determine the negative predictive value of Systematic Endoscopic Evaluation (SEE) in identifying patients without residual urothelial carcinoma.

Main Methods:

• A prospective single-arm study enrolled 61 patients undergoing radical cystectomy for urothelial carcinoma.
• Systematic Endoscopic Evaluation included cystoscopy and tissue sampling at the time of radical cystectomy.
• SEE results were compared to final radical cystectomy pathology to assess predictive accuracy.

Main Results:

• Of 31 patients with no visual or biopsy-based evidence of disease (seeT0) on SEE, 16 (51.6%) had residual disease (>pT0) upon radical cystectomy.
• Notably, 8 of these patients (25.8%) had residual muscle-invasive bladder cancer (≥pT2).
• The negative predictive value of SEE for predicting pT0 bladder cancer was 48.4%, falling below the prespecified hypothesis, leading to trial futility.

Conclusions:

• Systematic Endoscopic Evaluation has significant limitations in accurately assessing pT0 bladder cancer.
• Approximately one in four patients appearing disease-free via endoscopy still harbor residual muscle-invasive bladder cancer.
• Future research should explore novel imaging and biomarker strategies to improve pre-cystectomy evaluations for better decision-making.