Compares bladder-sparing treatment with bladder removal for bladder cancer
Observes adults with recurring non-muscle-invasive bladder cancer treated with bladder-sparing therapy or surgery.
Plain-language title generated from the registry record
Registry title: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
Key facts
- Where
- Chapel Hill, Columbus, Iowa City, Nashville, Seattle, and Tampa, United StatesSee the 6 sites
Where in United States
- University of North CarolinaChapel Hill, United StatesTaking people
- The Ohio State UniversityColumbus, United StatesTaking people
- University of IowaIowa City, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, United StatesTaking people
- H Lee Moffitt Cancer Center & Research InstituteTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Washington
- Trial code
- NCT07225127
- Record updated
- 21 October 2026
- Original description
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).Read full original descriptionShow less
Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
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).
Inclusion: Adult 18 years of age or older; and; Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:; Pathology documentation from any hospital/clinic/medical center; More than 50% urothelial carcinoma component in the specimen; and; History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and; 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: Previous history of cystectomy or radiation therapy for bladder cancer; Previous history of muscle-invasive bladder cancer or metastatic bladder cancer; Contraindication to BST (i.e., intolerant of all intravesical and intravenous medical therapies); 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; 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; Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation); Incarcerated in a detention facility or in police custody at baseline/screening (patients wearing a monitoring device can be enrolled); Contraindication to radical cystectomy (e.g., ASA of 4, patient not considered a radical cystectomy candidate due to comorbidity); Unable to provide written informed consent in English; Unable to be contacted for research surveys.