For additional information about this clinical trial, click here.
Bladder cancer is the most common urinary tract cancer, affecting men and women, and is the 5th most common cancer in the US (1). 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 (CISTO) for Bladder Cancer Study 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 CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
Most bladder cancer patients (74%) present with NMIBC where the cancer is limited to the
lining or support layer of the bladder. High-grade NMIBC is treated initially with endoscopic
resection and intravesical immunotherapy, followed by bladder instillations of BCG. Most
patients with high-risk, high-grade NMIBC are able to retain their bladders and avoid more
invasive treatments. However, 24-61% of patients will have their cancers recur within 12
months of treatment with BCG (BCG failures), and they have limited treatment options.
National guidelines recommend consideration between two alternatives: additional medical
management and radical cystectomy (removal of the bladder). Selecting between these options
involves weighing the risk of progression of bladder cancer and loss of a window of potential
cure versus the risk of morbidity and loss of quality of life (QOL) with bladder removal.
This complex decision-making engages patients and their caregivers, who may be impacted by
the urinary, sexual, and bowel dysfunctions that can occur with NMIBC treatment.
The investigators will evaluate this research question on a large scale in real world
practice settings including academic and community-based practices and examine
patient-centered outcomes. The investigators have engaged stakeholders with diverse
perspectives relevant to this research question, including patients, caregivers, national
patient advocacy organizations, national medical specialty organizations, guideline
developers, health care payers, and industry. By engaging broad expertise relevant to this
research question, the investigators will ensure that the study results will help NMIBC
patients whose cancer recurs after BCG treatment make more informed decisions that improve
the health outcomes that are important to them.
CISTO is an observational study that will not affect the treatment that patients chose.
Patient surveys will occur at study entry and at follow-up assessments for up to four years.
Caregiver surveys will occur at study entry and at the 12-month follow-up assessment. There
will also be a qualitative sub-study that will include interviews of approximately 50
patients and 25 caregivers recruited from the observational cohort study.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||July 9, 2019||Observational|
Primary Outcome 1 - Measure: Patient-reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)
Primary Outcome 1 - Time Frame: 12 months after completion of the patient baseline assessment
Patient Eligibility, 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, and
2. Documentation of muscle in the specimen, and
3. More than 50% urothelial carcinoma component in the specimen
3. History of high-grade NMIBC established by anatomic pathology as tumor stage
classification Tis, Ta, or T1; and
4. Attempted or received induction BCG (at least 3 out of 6 instillations) at any point
in time; and
5. Received at least one instillation of any intravesical agent within previous 12
Patient Eligibility, Exclusion Criteria:
1. Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or
2. Previous history of cystectomy or radiation therapy for bladder cancer;
3. Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;
4. Incarcerated in a detention facility or in police custody (patients wearing a
monitoring device can be enrolled) at baseline/screening;
5. Contraindication to radical cystectomy (e.g., ASA of 4);
6. Contraindication to intravesical therapy (i.e., intolerant of all intravesical
7. Unable to provide written informed consent in English;
8. Unable to be contacted for research surveys;
9. Planning to participate in a Phase I/II interventional clinical trial for NMIBC or any
blinded interventional trial for NMIBC.
Caregiver Eligibility, Inclusion Criteria:
1. Adult 18 years of age or older
Caregiver Eligibility, Exclusion Criteria:
1. Unable to provide written informed consent in English;
2. Unable to be contacted for research surveys.
Minimum Age: 18 Years
Maximum Age: N/A
Name: John L Gore, MD
Role: Principal Investigator
Affiliation: University of Washington
Name: On Ho, PhD
|University of North Carolina
Chapel Hill, North Carolina 27514
|Not yet recruiting||
Dana Mueller, MPH
|University of Washington
Seattle, Washington 98195
On Ho, PhD