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NCT07225127Recruiting

Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2

University of Washington

Start Date

11/3/2025

Completion Date

12/1/2028

Summary

Bladder cancer is the most common urinary tract cancer and the 6th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer Study 2 (CISTO2) has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO2 is to conduct a large prospective study that directly compares the impact of bladder sparing therapies versus bladder removal in recurrent high-grade NMIBC patients on financial toxicity, clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Adult 18 years of age or older; and 2. Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with: 1. Pathology documentation from any hospital/clinic/medical center 2. More than 50% urothelial carcinoma component in the specimen; and 3. History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and 4. In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment. Exclusion Criteria: 1. Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation); 2. Previous history of cystectomy or radiation therapy for bladder cancer; 3. Previous history of muscle-invasive bladder cancer or metastatic bladder cancer; 4. Untreated or current urinary tract urothelial carcinoma outside of the bladder (e.g. ureters, renal pelvis, penile urethra for males, urethra for females). Urinary tract cancer outside of the bladder treated more than 2 years ago is not an exclusion; 5. Incarcerated in a detention facility or in police custody at baseline/screening (patients wearing a monitoring device can be enrolled); 6. Contraindication to radical cystectomy (e.g., ASA of 4, patient not considered a radical cystectomy candidate due to comorbidity); 7. Contraindication to BST (i.e., intolerant of all intravesical and intravenous medical therapies); 8. Unable to provide written informed consent in English; 9. Unable to be contacted for research surveys; 10. Planning to participate in a blinded interventional clinical trial for NMIBC such that details about treatment or therapy received will be unavailable for data collection.

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Conditions

Bladder CancerRecurrent Bladder CancerNon-muscle Invasive Bladder Cancer (NMIBC)

Locations

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida 33612

United States

University of Iowa

Iowa City, Iowa 52242

United States

University of North Carolina

Chapel Hill, North Carolina 27599

United States

The Ohio State University

Columbus, Ohio 43210

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington 98195

United States