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

Overview

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).

Primary outcome measures

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

Secondary outcome measures (12)

• Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST) [Time frame: 24 months after enrollment]
• Caregiver self-reported financial distress as measured by the modified Comprehensive Score for Financial Toxicity (COST) [Time frame: 12 months after enrollment]
• Patient self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale [Time frame: 12 months after enrollment]
• Caregiver self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale [Time frame: 12 months after enrollment]
• Caregiver self-reported quality of life as measured by the CareGiver Oncology Quality of Life questionnaire (CarGOQol) [Time frame: 12 months after enrollment]
• Patient-reported quality of life as measured by the Physical Function scale of the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30) [Time frame: 12 months after enrollment]
• Patient self-reported urinary health as measured by the Bladder Cancer Index urinary summary score [Time frame: 12 months after enrollment]
• Patient-reported anxiety as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a [Time frame: 12 months after enrollment]
• Patient-reported depression as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a [Time frame: 12 months after enrollment]
• Caregiver-reported anxiety as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a [Time frame: 12 months after enrollment]
• Caregiver-reported depression as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a [Time frame: 12 months after enrollment]
• Patient-reported generic quality of life as measured by the EuroQoL EQ-5D-5L [Time frame: 12 months after enrollment]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 6 centers

• H. Lee Moffitt Cancer Center & Research Institute — Tampa
• University of Iowa — Iowa City
• University of North Carolina — Chapel Hill
• The Ohio State University — Columbus
• Vanderbilt University Medical Center — Nashville
• Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT07225127 · RG1126118 · R01CA289268

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗