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

NCT07225127 | Recruiting

• 2 other identifiers: RG1126118R01CA289268
• Study Type: observational
• Target: 408
• Locations: 1 country
• Sites: 6

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)

Outcome Measures

Primary Outcomes (1)

• Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST)

  The primary outcome of patient-reported financial toxicity is measured by the COST measure. The questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.

  12 months after enrollment

Secondary Outcomes (15)

• Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST)

  24 months after enrollment

• Caregiver self-reported financial distress as measured by the modified Comprehensive Score for Financial Toxicity (COST)

  12 months after enrollment

• Patient self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale

  12 months after enrollment

• Caregiver self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale

  12 months after enrollment

• Caregiver self-reported quality of life as measured by the CareGiver Oncology Quality of Life questionnaire (CarGOQol)

  12 months after enrollment

Study Arms (4)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of recurrent high-grade NMIBC who are considering their next treatment will be approached for participation in this observational study in addition to their caregivers.

You may qualify if:

• 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.

You may not qualify if:

• Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);
• Previous history of cystectomy or radiation therapy for bladder cancer;
• Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;
• 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);
• Contraindication to BST (i.e., intolerant of all intravesical and intravenous medical 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 such that details about treatment or therapy received will be unavailable for data collection.

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

NOT YET RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

NOT YET RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• John L Gore, MD, MS

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Min Kim

CONTACT

206-210-4040; cistorc@uw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Research, Professor, School of Medicine: Urology

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 5, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)