Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2 (CISTO2)

University of Washington

Status: Enrolling

Conditions: Bladder Cancer; Recurrent Bladder Cancer; Non-muscle Invasive Bladder Cancer (NMIBC)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07225127

RG1126118

R01CA289268 (U.S. NIH Grant/Contract)

Details and patient eligibility

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).

Enrollment: 408 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

408 participants in 4 patient groups

Patients who have selected radical cystectomy

Description:

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

Patients who have selected bladder-sparing therapy

Description:

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

Caregivers of patients who have selected radical cystectomy

Description:

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

Description:

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