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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• H. Lee Moffitt Cancer Center & Research Institute
  Tampa, Florida, United States Recruiting
• University of Iowa
  Iowa City, Iowa, United States Recruiting
• University of North Carolina
  Chapel Hill, North Carolina, United States Recruiting
• The Ohio State University
  Columbus, Ohio, United States 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
• Email: cistorc@uw.edu
• Phone: 206-210-4040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.