Observation Versus Immediate Surgery of Low Risk Bladder Cancer

Study Overview
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Brief Summary
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This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.

Official Title
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Observation Versus Immediate Surgery of Low Risk Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Other: Immediate Surgery
* Other: Observation
* Procedure: Surveillance Cystoscopy and Urinary Cytology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of low grade, noninvasive urothelial carcinoma of the bladder with a new recurrence that meets the following criteria: total tumor burden ≤3cm in size (multiple lesions permitted) low grade appearance (grade 1 or grade 2) noninvasive appearance (Ta) no history of carcinoma in situ (CIS) or lesions concerning for CIS negative urine cytology (atypical or suspicious for low grade neoplasm are acceptable) Exclusion Criteria: High grade and/or invasive and/or carcinoma in situ disease Concomitant upper tract urothelial carcinoma Any patient who is pregnant or who may have plans to become pregnant. Positive cytology

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observation<br>Patients will not undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Surgery will commence after 12 months of observation or sooner if cystoscopic evidence of disease progression or patient desire. | Other: Observation<br> <br> * Other names: Active Surveillance;Procedure: Surveillance Cystoscopy and Urinary Cytology<br>* Cytology and cystoscopy are done at the same time<br>|
| Other: Immediate Surgery<br>Patients will undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Repeated surgery will be offered for additional recurrences. | Other: Immediate Surgery<br> <br> * Other names: Transurethral Resection of Bladder Tumor;Procedure: Surveillance Cystoscopy and Urinary Cytology<br>* Cytology and cystoscopy are done at the same time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-Free Survival | An event is a complication of any kind, including bleeding requiring blood transfusion, bladder perforation, urinary tract infection, readmission to the hospital, and progression of disease. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with disease progression (either stage or grade) | proportion of patients with disease progression (either stage or grade) | 12 months | 
| Patient-reported Costs | out of pocket medical costs | At baseline and 3 months, 6 months, 9 months and 12 months. | 
| Self-reported patient anxiety measured using the EORTC QLQ-NMIBC24 | Measured using the EORTC QLQ-NMIBC24, which is a 24-item questionnaire for patients with superficial bladder cancer. This will be assessed at baseline and every 3 months during the study. | At baseline and 3 months, 6 months, 9 months and 12 months. |