Bladder CancerCISTONCT03933826
CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer
An observational study of Bladder Cancer and Cancer of the Bladder, Recurrent, run by University of Washington at 36 sites in United States.
Trial summary
Bladder cancer is the most common urinary tract cancer and 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Cancer of the Bladder, Recurrent, Non-muscle Invasive Bladder Cancer
- How many people
- 570 participants
- Where
- 36 sitesUnited States
- Study dates
- 9 Jul 2019to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with a diagnosis of recurrent high-grade NMIBC who are considering second-line treatment will be approached for participation in this observational study in addition to their caregivers. Enrollment at each site will aim for a 2:1 ratio of participants selecting bladder-sparing therapy to radical cystectomy in order to ensure adequate enrollment of radical cystectomy patients. There will also be a qualitative sub-study that will include interviews of 50 patients and 25 caregivers recruited from the observational cohort study.
Patient Eligibility, 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, and
- More than 50% urothelial carcinoma component in the specimen
- History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and
- Attempted or received induction BCG (at least 3 out of 6 instillations) at any point in time; 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.
Patient Eligibility, 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;
- Any history of upper tract urothelial carcinoma;
- Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
- Contraindication to radical cystectomy (e.g., American Society of Anesthesiologists (ASA) physical status of 4, patient not considered a radical cystectomy candidate due to comorbidity);
- Contraindication to medical therapy (i.e., intolerant of all medical therapies);
- Unable to provide written informed consent in English;
- Unable to be contacted for research surveys;
- Planning to participate in a Phase I or Phase II interventional clinical trial for NMIBC (unless in the control/comparator arm of a Phase II trial) or any blinded interventional trial for NMIBC.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Michigan Medicine Rogel Cancer Center
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Johns Hopkins University, School of Medicine
Baltimore, Maryland, 21231
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27599
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Chicago
Chicago, Illinois, 60637
The Ohio State University
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390
Geisinger Medical Center
Danville, Pennsylvania, 17822
Spectrum Health
Grand Rapids, Michigan, 49503
Chesapeake Urology Research Associates
Hanover, Maryland, 21076
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
USC/Norris Comprehensive CA Center
Los Angeles, California, 90033
UCLA
Los Angeles, California, 90095
Asante Rogue Regional Medical Center
Medford, Oregon, 97504
LSU Healthcare Network - Multi Specialty Clinic
Metairie, Louisiana, 70006
University of Miami
Miami, Florida, 33136
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
Urology Associates, P.C.
Nashville, Tennessee, 37209
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73114
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19122
Mayo Clinic Cancer Center
Phoenix, Arizona, 85054
Comprehensive Urology -- A Division of Michigan Healthcare Professionals
Royal Oak, Michigan, 48073
University of Utah
Salt Lake City, Utah, 84132
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
University of Washington
Seattle, Washington, 98195
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Bladder cancer is the most common urinary tract cancer and 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 non-muscle-invasive bladder cancer (NMIBC), 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 Bacillus Calmette-Guerin (BCG) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
Read the detailed description
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. 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.
- Keywords
- pragmatic trial, Bacillus Calmette-Guerin (BCG), urinary bladder neoplasms, urogenital neoplasms, radical cystectomy, neoplasms by site, neoplasms, urinary bladder disease, immunologic factors, caregivers, physiological effects of drugs, immunologic adjuvants, urologic diseases
- Medical subject headings
- Urinary Bladder Neoplasms, Recurrence, Non-Muscle Invasive Bladder Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Urinary Bladder Diseases, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
The primary outcome of patient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items in order to be calculated.
Measured: 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)
Patient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items in order to be calculated.
Measured: 24 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)
Patient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items in order to be calculated.
Measured: 60 months after enrollment
Secondary outcomes (36)
Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score
The evaluation of the effect of treatment choice on patient-reported urinary health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate the two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Measured: 12 months after enrollment
Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score
The evaluation of the effect of treatment choice on patient-reported urinary health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate the two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Measured: 24 months after enrollment
Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score
The evaluation of the effect of treatment choice on patient-reported urinary health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate the two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Measured: 60 months after enrollment
Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score
The evaluation of the effect of treatment choice on patient-reported sexual health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Measured: 12 months after enrollment
Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score
The evaluation of the effect of treatment choice on patient-reported sexual health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Measured: 24 months after enrollment
Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score
The evaluation of the effect of treatment choice on patient-reported sexual health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Measured: 60 months after enrollment
Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score
The evaluation of the effect of treatment choice on patient-reported bowel health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Measured: 12 months after enrollment
Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score
The evaluation of the effect of treatment choice on patient-reported bowel health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Measured: 24 months after enrollment
Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score
The evaluation of the effect of treatment choice on patient-reported bowel health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Measured: 60 months after enrollment
Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST)
The evaluation of the effect of treatment choice on patient-reported financial distress, as measured by the Comprehensive Score for Financial Toxicity (COST). The COST 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 greater financial wellbeing. Each subscale requires responses for at least 50% of the items in that subscale in order to be calculated. Item nonresponse is accounted for by substituting the mean of the completed items in the subscale.
Measured: 12 months after enrollment
Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST)
The evaluation of the effect of treatment choice on patient-reported financial distress, as measured by the Comprehensive Score for Financial Toxicity (COST). The COST 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 greater financial wellbeing. Each subscale requires responses for at least 50% of the items in that subscale in order to be calculated. Item nonresponse is accounted for by substituting the mean of the completed items in the subscale.
Measured: 24 months after enrollment
Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST)
The evaluation of the effect of treatment choice on patient-reported financial distress, as measured by the Comprehensive Score for Financial Toxicity (COST). The COST 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 greater financial wellbeing. Each subscale requires responses for at least 50% of the items in that subscale in order to be calculated. Item nonresponse is accounted for by substituting the mean of the completed items in the subscale.
Measured: 60 months after enrollment
Patient-reported Anxiety as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
The evaluation of patient-reported anxiety, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Measured: 12 months after enrollment
Patient-reported Anxiety as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
The evaluation of patient-reported anxiety, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Measured: 24 months after enrollment
Patient-reported Anxiety as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
The evaluation of patient-reported anxiety, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Measured: 60 months after enrollment
Patient-reported Depression as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
The evaluation of patient-reported depression, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Measured: 12 months after enrollment
Patient-reported Depression as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
The evaluation of patient-reported depression, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Measured: 24 months after enrollment
Patient-reported Depression as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
The evaluation of patient-reported depression, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Measured: 60 months after enrollment
Patient-reported Generic Quality of Life as Measured by the EuroQoL EQ-5D-5L
The evaluation of patient-reported generic quality of life as measured by the EuroQoL EQ-5D-5L (EQ-5D). Scores range from 0 to 1, with higher scores indicating better health.
Measured: 12 months after enrollment
Patient-reported Generic Quality of Life as Measured by the EuroQoL EQ-5D-5L
The evaluation of patient-reported generic quality of life as measured by the EuroQoL EQ-5D-5L (EQ-5D). Scores range from 0 to 1, with higher scores indicating better health.
Measured: 24 months after enrollment
Patient-reported Generic Quality of Life as Measured by the EuroQoL EQ-5D-5L
The evaluation of patient-reported generic quality of life as measured by the EuroQoL EQ-5D-5L (EQ-5D). Scores range from 0 to 1, with higher scores indicating better health.
Measured: 60 months after enrollment
Patient Recurrence-free Survival
The evaluation of the effect of treatment choice on recurrence-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (recurrence or death). A recurrence was defined as any subsequent episode of high-grade bladder cancer in the bladder or elsewhere in the urinary tract (penile urethra, prostatic urethra, ureters, renal pelvis), either non-muscle or muscle invasive bladder cancer (for cystectomy arm this excludes any finding at cystectomy). Censoring occurred at the last electronic health record review or death.
Measured: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Recurrence-free Survival
The evaluation of the effect of treatment choice on recurrence-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (recurrence or death). A recurrence was defined as any subsequent episode of high-grade bladder cancer in the bladder or elsewhere in the urinary tract (penile urethra, prostatic urethra, ureters, renal pelvis), either non-muscle or muscle invasive bladder cancer (for cystectomy arm this excludes any finding at cystectomy). Censoring occurred at the last electronic health record review or death.
Measured: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Recurrence-free Survival
The evaluation of the effect of treatment choice on recurrence-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (recurrence or death). A recurrence was defined as any subsequent episode of high-grade bladder cancer in the bladder or elsewhere in the urinary tract (penile urethra, prostatic urethra, ureters, renal pelvis), either non-muscle or muscle invasive bladder cancer (for cystectomy arm this excludes any finding at cystectomy). Censoring occurred at the last electronic health record review or death.
Measured: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Metastasis-free Survival
The evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A metastasis was defined as metastasis to distant lymph/nodes organs (pathologic or radiologic diagnosis of M+ disease) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Measured: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Metastasis-free Survival
The evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A metastasis was defined as metastasis to distant lymph/nodes organs (pathologic or radiologic diagnosis of M+ disease) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Measured: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Metastasis-free Survival
The evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A metastasis was defined as metastasis to distant lymph/nodes organs (pathologic or radiologic diagnosis of M+ disease) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Measured: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Progression-free Survival
The evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A progression was defined as any subsequent episode of muscle-invasive (T2-T4) disease in the bladder or elsewhere in the urinary tract AND/OR locoregional (true pelvic/common iliac) nodal disease (N+) AND/OR distant metastasis (M+) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Measured: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Progression-free Survival
The evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A progression was defined as any subsequent episode of muscle-invasive (T2-T4) disease in the bladder or elsewhere in the urinary tract AND/OR locoregional (true pelvic/common iliac) nodal disease (N+) AND/OR distant metastasis (M+) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Measured: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Progression-free Survival
The evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A progression was defined as any subsequent episode of muscle-invasive (T2-T4) disease in the bladder or elsewhere in the urinary tract AND/OR locoregional (true pelvic/common iliac) nodal disease (N+) AND/OR distant metastasis (M+) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Measured: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Bladder Cancer-specific Survival
The evaluation of the effect of treatment choice on bladder cancer-specific survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death from bladder cancer). Censoring occurred at the last electronic health record review or date of death from bladder cancer.
Measured: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Bladder Cancer-specific Survival
The evaluation of the effect of treatment choice on bladder cancer-specific survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death from bladder cancer). Censoring occurred at the last electronic health record review or date of death from bladder cancer.
Measured: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Bladder Cancer-specific Survival
The evaluation of the effect of treatment choice on bladder cancer-specific survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death from bladder cancer). Censoring occurred at the last electronic health record review or date of death from bladder cancer.
Measured: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Overall Survival
The evaluation of the effect of treatment choice on overall survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death). Censoring occurred at the last electronic health record review or date of death.
Measured: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Overall Survival
The evaluation of the effect of treatment choice on overall survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death). Censoring occurred at the last electronic health record review or date of death.
Measured: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Overall Survival
The evaluation of the effect of treatment choice on overall survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death). Censoring occurred at the last electronic health record review or date of death.
Measured: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start9 Jul 2019
- Primary completion31 Jan 2025
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, John Gore, University of Washington
- Investigators
- John L Gore, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933826
- Sponsor's protocol ID
- SITE00001017
- Other IDs
- PCS-2017C3-9380, RG1121143, NCI-2020-06082
- Acronym
- CISTO
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2019
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data will be shared according to the PCORI policy for data management and data sharing.
Publications
Gore JL, Wolff EM, Nash MG, Comstock BA, Gilbert SM, Chang SS, Chisolm S, MacLean DB, Wright JL, Kates MR, Pohar KS, Guzzo TJ, Bivalacqua TJ, Nepple KG, Montgomery JS, Scarpato KR, Woldu SL, Master VA, Chen DYT, Mossanen M, Daneshmand S, O'Neil BB, Tyson MD, Westerman ME, Kamat AM, Mansour AM, Chamie K, Riggs SB, Kukreja JB, Modi PK, Garg T, Peyton CC, Nix JW, Dickstein R, Gadzinski AJ, Sankin A, Shore ND, Lane BR, Bassett JC, Patel S, Morris DS, Macleod LC, Lee EK, Ritch CR, Follmer KM, Lee JR, Kim SM, Kessler LG, Smith AB; CISTO Collaborative group. Twelve-Month Results From the CISTO Study Comparing Radical Cystectomy Versus Bladder-Sparing Therapy for Recurrent High-Grade Non-Muscle-Invasive Bladder Cancer. J Clin Oncol. 2026 Feb;44(4):274-285. doi: 10.1200/JCO-25-01324. Epub 2025 Dec 15.
PubMed 41397208Gore JL, Wolff EM, Comstock BA, Follmer KM, Nash MG, Basu A, Chisolm S, MacLean DB, Lee JR, Lotan Y, Porten SP, Steinberg GD, Chang SS, Gilbert SM, Kessler LG, Smith AB; CISTO Collaborative. Protocol of the Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) study: a pragmatic, prospective multicenter observational cohort study of recurrent high-grade non-muscle invasive bladder cancer. BMC Cancer. 2023 Nov 18;23(1):1127. doi: 10.1186/s12885-023-11605-8.
PubMed 37980511
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer
- ClinicalTrials.gov ID
- NCT03933826
- Acronym / sponsor ID
- CISTO / SITE00001017
- Keywords
- pragmatic trial, Bacillus Calmette-Guerin (BCG), urinary bladder neoplasms, urogenital neoplasms, radical cystectomy, neoplasms by site, neoplasms, urinary bladder disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 570 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Posted 4 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bladder cancer is the most common urinary tract cancer and 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 non-muscle-invasive bladder cancer (NMIBC), 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 Bacillus Calmette-Guerin (BCG) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
Detailed description
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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of recurrent high-grade NMIBC who are considering second-line treatment will be approached for participation in this observational study in addition to their caregivers. Enrollment at each site will aim for a 2:1 ratio of participants selecting bladder-sparing therapy to radical cystectomy in order to ensure adequate enrollment of radical cystectomy patients. There will also be a qualitative sub-study that will include interviews of 50 patients and 25 caregivers recruited from the observational cohort study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
The primary outcome of patient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items in order to be calculated.
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: 24 months after enrollment
Patient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items in order to be calculated.
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: 60 months after enrollment
Patient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items in order to be calculated.
36 secondary outcomes
Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score
Time frame: 12 months after enrollment
Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score
Time frame: 24 months after enrollment
Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score
Time frame: 60 months after enrollment
Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score
Time frame: 12 months after enrollment
Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score
Time frame: 24 months after enrollment
Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score
Time frame: 60 months after enrollment
Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score
Time frame: 12 months after enrollment
Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score
Time frame: 24 months after enrollment
Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score
Time frame: 60 months after enrollment
Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST)
Time frame: 12 months after enrollment
Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST)
Time frame: 24 months after enrollment
Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST)
Time frame: 60 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 Anxiety as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
Time frame: 24 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: 60 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
Patient-reported Depression as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
Time frame: 24 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: 60 months after enrollment
Patient-reported Generic Quality of Life as Measured by the EuroQoL EQ-5D-5L
Time frame: 12 months after enrollment
Patient-reported Generic Quality of Life as Measured by the EuroQoL EQ-5D-5L
Time frame: 24 months after enrollment
Patient-reported Generic Quality of Life as Measured by the EuroQoL EQ-5D-5L
Time frame: 60 months after enrollment
Patient Recurrence-free Survival
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Recurrence-free Survival
Time frame: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Recurrence-free Survival
Time frame: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Metastasis-free Survival
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Metastasis-free Survival
Time frame: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Metastasis-free Survival
Time frame: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Progression-free Survival
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Progression-free Survival
Time frame: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Progression-free Survival
Time frame: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Bladder Cancer-specific Survival
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Bladder Cancer-specific Survival
Time frame: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Bladder Cancer-specific Survival
Time frame: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Overall Survival
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Overall Survival
Time frame: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Overall Survival
Time frame: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41397208Gore JL, Wolff EM, Nash MG, Comstock BA, Gilbert SM, Chang SS, Chisolm S, MacLean DB, Wright JL, Kates MR, Pohar KS, Guzzo TJ, Bivalacqua TJ, Nepple KG, Montgomery JS, Scarpato KR, Woldu SL, Master VA, Chen DYT, Mossanen M, Daneshmand S, O'Neil BB, Tyson MD, Westerman ME, Kamat AM, Mansour AM, Chamie K, Riggs SB, Kukreja JB, Modi PK, Garg T, Peyton CC, Nix JW, Dickstein R, Gadzinski AJ, Sankin A, Shore ND, Lane BR, Bassett JC, Patel S, Morris DS, Macleod LC, Lee EK, Ritch CR, Follmer KM, Lee JR, Kim SM, Kessler LG, Smith AB; CISTO Collaborative group. Twelve-Month Results From the CISTO Study Comparing Radical Cystectomy Versus Bladder-Sparing Therapy for Recurrent High-Grade Non-Muscle-Invasive Bladder Cancer. J Clin Oncol. 2026 Feb;44(4):274-285. doi: 10.1200/JCO-25-01324. Epub 2025 Dec 15.
- Derived from this study: PubMed 37980511Gore JL, Wolff EM, Comstock BA, Follmer KM, Nash MG, Basu A, Chisolm S, MacLean DB, Lee JR, Lotan Y, Porten SP, Steinberg GD, Chang SS, Gilbert SM, Kessler LG, Smith AB; CISTO Collaborative. Protocol of the Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) study: a pragmatic, prospective multicenter observational cohort study of recurrent high-grade non-muscle invasive bladder cancer. BMC Cancer. 2023 Nov 18;23(1):1127. doi: 10.1186/s12885-023-11605-8.
- Individual participant dataSharing planned: Yes. De-identified study data will be shared according to the PCORI policy for data management and data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John L Gore, MD principal investigator
University of Washington
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Cancer of the Bladder, Recurrent, run by University of Washington at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933826, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.