Trial results for the CISTO study, comparing treatment options for Bladder Cancer, were posted on ClinicalTrials.gov on 2025-11-04, involving 570 participants.
Background
Bladder cancer is recognized as the most common urinary tract cancer and the 5th most common cancer in the US. Despite its prevalence, bladder cancer research often faces underfunding compared to other common cancers. This situation can lead to critical evidence gaps, resulting in decision uncertainty for both patients and clinicians regarding optimal care pathways. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study was designed to address these evidence gaps, aiming to potentially modify care pathways for non-muscle-invasive bladder cancer (NMIBC) and facilitate personalized, patient-centered management.
Trial design
The CISTO study, which is currently active but not recruiting, enrolled 570 participants. The trial investigated treatment options for conditions including Bladder Cancer, Cancer of the Bladder, Recurrent, and Non-muscle Invasive Bladder Cancer. The study compared patient-reported outcomes between two groups: those who selected bladder-sparing therapy and those who selected radical cystectomy.
Key results
The trial reported several key measurements related to patient-reported outcomes:
- Patient-reported Quality of Life as Measured by the Physical Function Scale of the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30) (score on a scale):
- Patients Who Have Selected Bladder-sparing Therapy: Mean score of 85.0 (Standard Deviation 18.9).
- Patients Who Have Selected Radical Cystectomy: Mean score of 86.5 (Standard Deviation 17.5).
- Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score (score on a scale):
- Patients Who Have Selected Bladder-sparing Therapy: Mean score of 85.3 (Standard Deviation 16.7).
- Patients Who Have Selected Radical Cystectomy: Mean score of 83.8 (Standard Deviation 14.2).
- Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score (score on a scale):
- Patients Who Have Selected Bladder-sparing Therapy: Mean score of 47.1 (Standard Deviation 25.7).
- Patients Who Have Selected Radical Cystectomy: Mean score of 32.6 (Standard Deviation 20.1).
- Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score (score on a scale):
- Patients Who Have Selected Bladder-sparing Therapy: Mean score of 80.1 (Standard Deviation 9.5).
- Patients Who Have Selected Radical Cystectomy: Mean score of 77.2 (Standard Deviation 10.8).
- Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST) (score on a scale):
- Patients Who Have Selected Bladder-sparing Therapy: Mean score of 30.4 (Standard Deviation 9.9).
- Patients Who Have Selected Radical Cystectomy: Mean score of 31.0 (Standard Deviation 9.4).
- Patient-reported Anxiety as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a (T-score):
- Patients Who Have Selected Bladder-sparing Therapy: Mean score of 50.0 (Standard Deviation 8.9).
- Patients Who Have Selected Radical Cystectomy: Mean score of 48.8 (Standard Deviation 8.9).
Key analyses included:
- An Average treatment estimate (ATE) of 0.9 (95.0% CI: -0.6 to 2.4) was calculated using the TMLE method, with a p-value of 0.05.
- Further estimates using the TMLE method included 1.2 (95.0% CI: -0.5 to 2.9), -11.9 (95.0% CI: -14.7 to -9.0), -1.4 (95.0% CI: -2.5 to -0.3), 1.4 (95.0% CI: 0.2 to 2.6), and -2.4 (95.0% CI: -3.1 to -1.6).
What this means
The CISTO trial results provide valuable comparative data on patient-reported outcomes for bladder-sparing therapy versus radical cystectomy in bladder cancer management. The findings highlight differences across various quality of life domains, with a notable distinction in patient self-reported sexual health, where bladder-sparing therapy was associated with a higher mean score compared to radical cystectomy. While some average treatment estimates show confidence intervals that do not cross zero, suggesting potential differences, the specific outcomes these estimates relate to are not detailed in the provided analysis. These results contribute to the evidence base, informing shared decision-making for patients and clinicians considering treatment options for bladder cancer.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03933826, titled "CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer", were posted on 2025-11-04 on clinicaltrials.gov.