Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study

Study Overview
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Brief Summary
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This is a two-arm, randomized-controlled pilot study with 2 year duration. The intervention refers to surveillance based on the European Association of Urology (EAU) guidelines and the control refers to surveillance based on the American Urological Association (AUA) guidelines.

Detailed Description
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This is a two-arm, randomized-controlled pilot study with 2 year duration. The intervention refers to surveillance based on the EAU guidelines and the control refers to surveillance based on the AUA guidelines. Research methods: Participants who presents with non-muscle invasive bladder cancer and meets the inclusion/exclusion criteria will be given an option to participate in the study. Participants will be enrolled at the Urology Clinics at the University of Texas Health Science Center San Antonio (UTHSCSA) Medical Arts and Research Center (MARC) and South Texas Veterans Health Care System (STVHCS). Non-local site include the University of Texas Southwestern Medical Center (UTSW). The research procedures consist of urine collection, cystoscopy, and patient satisfaction and cost questionnaires. The evaluation will be done by the tumor recurrence and progression of the disease. At various time points throughout the study, urine may be obtained from the patient and banked in the Genitourinary (GU) Tissue Bank. Subjects asked to provide a urine sample(s) will be asked to sign a separate informed consent. The urine is de-identified in the lab per the Health Insurance Portability and Accountability Act (HIPAA) protocol GU Tissue Bank Institutional Review Board (IRB) # 20050234H). Patients will undergo cystoscopy in clinic (standard of care). In the intervention arm, patient surveillance cystoscopy will be performed at 3, 12 months and again at 24 months following the diagnosis of bladder cancer. Patients randomized to the control arm, will undergo surveillance cystoscopy every 3 months for 2 years following the diagnosis of bladder cancer. Because use of cytology is variable among the participating urologist, the utilization of cytology will be at the treating urologist's discretion as per usual standard care. Study duration will be 2 years from most recent biopsy. Patients will be placed on the surveillance schedule based on the length of time from their last tumor.

Official Title
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Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study

Conditions
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Bladder Cancer

Intervention / Treatment
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* Other: Intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have non-muscle invasive low-grade, papillary (Ta) bladder cancer. Must have a negative cystoscopy following most recent biopsy. Must be able to give informed consent. Must be age 18 or older. Must be at low- or low-intermediate risk for disease recurrence and progression according to the EAU guidelines. Exclusion Criteria: Have a history of invasive (>=T1) bladder cancer. Have a history of carcinoma-in-situ (CIS). Unable to give informed consent. < 18 or younger. Variant histology (micropapillary, nested variant, non-urothelial cell carcinoma elements). Had a surveillance cystoscopy following most recent biopsy.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>The intervention group refers to surveillance based on the EAU guidelines. | Other: Intervention<br>* Patients randomized into the intervention group will follow the European Urologic Association (EAU) surveillance guidelines for cystoscopy follow-ups during bladder cancer surveillance.<br>* Other names: EAU surveillance;|
| Control<br>The control group refers to surveillance based on the AUA guidelines. | Other: Control<br>* Patients randomized into the control group will follow the American Urologic Association (AUA) surveillance guidelines using cystoscopy ever 3 months for the first two years, and then every 6 months for 2 years.<br>* Other names: AUA Surveillance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate feasibility of study recruitment and retention in order to help plan for subsequent phase III study. |  | 2 years | 
| Develop methods for assessing patient satisfaction and costs associated with cystoscopy during bladder cancer surveillance. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capture preliminary data regarding number of procedures and direct and indirect cost differences between study arms. |  | 2 years | 
| Compare proportion of patients experiencing disease progression and recurrence at 2 years following most recent biopsy under two different surveillance approaches. |  | 2 years |