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

NCT ID: NCT03933826

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 570 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-09
• Study Completion Date: 2029-06-30

Brief 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. 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.

Conditions

Bladder Cancer; Cancer of the Bladder, Recurrent; Non-muscle Invasive Bladder Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients who have selected radical cystectomy

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

No interventions assigned to this group

Patients who have selected bladder-sparing therapy

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

No interventions assigned to this group

Eligibility Criteria

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. 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. 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. Any history of upper tract urothelial carcinoma;

5. Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;

6. 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);

7. Contraindication to medical therapy (i.e., intolerant of all 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

John Gore

Associate Professor, School of Medicine: Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John L Gore, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic Cancer Center

Phoenix, Arizona, United States

USC/Norris Comprehensive CA Center

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

University of Miami

Miami, Florida, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

LSU Healthcare Network - Multi Specialty Clinic

Metairie, Louisiana, United States

Johns Hopkins University, School of Medicine

Baltimore, Maryland, United States

Chesapeake Urology Research Associates

Hanover, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Michigan Medicine Rogel Cancer Center

Ann Arbor, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

Comprehensive Urology -- A Division of Michigan Healthcare Professionals

Royal Oak, Michigan, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Asante Rogue Regional Medical Center

Medford, Oregon, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States

Urology Associates, P.C.

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

Gore 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.

Reference Type: DERIVED

PMID: 37980511 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PCS-2017C3-9380

Identifier Type: OTHER

Identifier Source: secondary_id

RG1121143

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2020-06082

Identifier Type: REGISTRY

Identifier Source: secondary_id

SITE00001017

Identifier Type: -

Identifier Source: org_study_id