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

NCT03933826 | Active Not Recruiting Results DMC

• 4 other identifiers: SITE00001017PCS-2017C3-9380RG1121143NCI-2020-06082
• Study Type: observational
• Target: 570
• Locations: 1 country
• Sites: 36

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).

Conditions

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

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  60 months after enrollment

Secondary Outcomes (36)

• Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score

  12 months after enrollment

• Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score

  24 months after enrollment

• Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score

  60 months after enrollment

• Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score

  12 months after enrollment

• Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score

  24 months after enrollment

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (36)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic Cancer Center

Phoenix, Arizona, 85054, United States

Location

USC/Norris Comprehensive CA Center

Los Angeles, California, 90033, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

LSU Healthcare Network - Multi Specialty Clinic

Metairie, Louisiana, 70006, United States

Location

Johns Hopkins University, School of Medicine

Baltimore, Maryland, 21231, United States

Location

Chesapeake Urology Research Associates

Hanover, Maryland, 21076, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Michigan Medicine Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Comprehensive Urology -- A Division of Michigan Healthcare Professionals

Royal Oak, Michigan, 48073, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73114, United States

Location

Asante Rogue Regional Medical Center

Medford, Oregon, 97504, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19122, United States

Location

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Associates, P.C.

Nashville, Tennessee, 37209, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• 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.

  PMID: 41397208 DERIVED

• 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.

  PMID: 37980511 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Recurrence; Non-Muscle Invasive Bladder Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Dr. John Gore
• Organization: University of Washington

cistopm@uw.edu

206-543-9926

Study Officials

• John L Gore, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine: Urology

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: May 1, 2019
• Study Start: July 9, 2019
• Primary Completion: January 31, 2025
• Study Completion (Estimated): June 30, 2029
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The PCORI-designated repository will make the data available for third-party requests when PCORI makes the Final Research Report available on the PCORI website pursuant to PCORI's Process for Peer Review of Primary Research and Public Release of Research Findings. Data will be available in perpetuity.
• Access Criteria: Individual investigators or teams of investigators seeking access to data from PCORI-funded studies must complete and submit a data request form to the PCORI-designated repository.

Locations

US (36)