Actively Recruiting
Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
Led by University of Washington · Updated on 2026-04-21
408
Participants Needed
6
Research Sites
160 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult 18 years of age or older
- Presenting with high-grade non-muscle-invasive bladder cancer (NMIBC) classified as tumor stage Tis, Ta, or T1
- Pathology documentation from any hospital or medical center
- Tumor specimen contains more than 50% urothelial carcinoma component
- History of high-grade NMIBC diagnosed by anatomic pathology as tumor stage Tis, Ta, or T1
- Received at least one intravesical agent instillation or systemic therapy for NMIBC treatment in the past 12 months
You will not qualify if you...
- Any plasmacytoid or small cell (neuroendocrine) component in pathology, past or current
- Previous cystectomy or radiation therapy for bladder cancer
- Previous muscle-invasive or metastatic bladder cancer
- Untreated or current urinary tract urothelial carcinoma outside the bladder (ureters, renal pelvis, penile urethra for males, urethra for females), except if treated more than 2 years ago
- Incarcerated or in police custody at baseline/screening (wearing a monitoring device allowed)
- Contraindication to radical cystectomy due to comorbidity or ASA of 4
- Contraindication to bladder sparing therapy (intolerance to all intravesical and intravenous therapies)
- Unable to provide written informed consent in English
- Unable to be contacted for research surveys
- Planning to participate in a blinded interventional clinical trial for NMIBC that prevents data collection on treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Not Yet Recruiting
2
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
4
The Ohio State University
Columbus, Ohio, United States, 43210
Not Yet Recruiting
5
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
6
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
S
Sung Min Kim
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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