Recruiting

Bladder Sparing vs. Surgery

Sponsor:

University of Washington

Code:

NCT07225127

Conditions

Bladder Cancer

Recurrent Bladder Cancer

Non-muscle Invasive Bladder Cancer (NMIBC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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).

Conditions

Bladder Cancer

Recurrent Bladder Cancer

Non-muscle Invasive Bladder Cancer (NMIBC)

Study ID

NCT07225127

Start date

Nov 3, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

408 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients who have selected radical cystectomy

Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy

Patients who have selected bladder-sparing therapy

Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)

Caregivers of patients who have selected radical cystectomy

Caregivers of patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy

Caregivers of patients who have selected bladder-sparing therapy

Caregivers of patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)

Primary outcome measure

  • Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST) [ Time Frame: 12 months after enrollment ]

Central Contacts and Locations

Central contacts

Locations

H. Lee Moffitt Cancer Center & Research Institute

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Scott M Gilbert, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator:

Kenneth G Nepple, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Angela Smith, MD, MS

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Akshay Sood, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

Kristen Scarpato, MD

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98195

Contacts

Principal Investigator:

John L Gore, MD, MS

More Information

Sponsor

University of Washington

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2026-07-31.