Comparing bladder-sparing therapy versus bladder removal for recurrent high-grade NMIBC

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

This project will test whether bladder-sparing treatments or bladder removal work better for adults with recurrent high-grade non-muscle-invasive bladder cancer by looking at costs, health outcomes, and patient and caregiver experiences.

Quick facts

• Study type: Observational
• Enrollment: 408 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Washington (other)
• Drugs / interventions: radiation
• Locations: 6 sites (Tampa, Florida and 5 other locations)
• Trial ID: NCT07225127 on ClinicalTrials.gov

What this trial studies

CISTO2 is a large prospective, observational, multicenter comparison of bladder-sparing intravesical therapies versus bladder removal in adults with recurrent high-grade non–muscle-invasive bladder cancer. The study will enroll patients with pathology-confirmed Tis, Ta, or T1 disease who have received at least one intravesical or systemic therapy in the prior 12 months and will exclude those with prior cystectomy, radiation, muscle-invasive or metastatic disease, or non-urothelial histologies such as plasmacytoid or small cell. Investigators will collect standardized patient-reported outcomes, financial toxicity measures, and clinical endpoints over time to compare quality of life, caregiver experience, and cancer outcomes between treatment approaches. The multicenter design, led by the University of Washington with participating sites at H. Lee Moffitt, University of Iowa, and UNC and with NCI collaboration, aims to produce real-world evidence to guide personalized treatment decisions.

Who should consider this trial

Good fit: Adults 18 or older with recurrent high-grade NMIBC (Tis, Ta, or T1) confirmed by pathology who have had at least one intravesical or systemic therapy in the past 12 months are ideal candidates.

Not a fit: Patients with prior cystectomy or pelvic radiation, a history of muscle-invasive or metastatic bladder cancer, non-urothelial histologies like plasmacytoid or small cell, or untreated urothelial cancer outside the bladder are not eligible and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could help patients and clinicians choose the treatment option that best balances cancer control, quality of life, and financial burden.

How similar studies have performed: Some prior series and comparative studies have looked at bladder-sparing approaches versus cystectomy, but randomized data are limited and results are mixed, so a large prospective comparison remains relatively novel.

Eligibility criteria

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.

Where this trial is running

Tampa, Florida and 5 other locations

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States (NOT_YET_RECRUITING)
• University of Iowa — Iowa City, Iowa, United States (RECRUITING)
• University of North Carolina — Chapel Hill, North Carolina, United States (NOT_YET_RECRUITING)
• The Ohio State University — Columbus, Ohio, United States (NOT_YET_RECRUITING)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: John L Gore, MD, MS — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Sung Min Kim

Conditions: Bladder Cancer, Recurrent Bladder Cancer, Non-muscle Invasive Bladder Cancer