About this trial

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).

Eligibility criteria

Qualifiers

Adult 18 years of age or older; and

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

408 Participants
are grouped into 4 trial groups

Locations

6
Florida
H. Lee Moffitt Cancer Center & Research Institute33612, Tampa United States
Iowa
University of Iowa52242, Iowa City United States
North Carolina
University of North Carolina27599, Chapel Hill United States
Ohio
The Ohio State University43210, Columbus United States

Sponsors and collaborators

University of Washington

Lead sponsor

National Cancer Institute (NCI)

Collaborator