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Major study aims to settle debate on best bladder cancer treatment

NCT ID NCT03933826

Knowledge-focused Sponsor: University of Washington Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two common treatments for recurrent non-muscle-invasive bladder cancer: medical therapy (drugs placed in the bladder) and surgery (bladder removal). Researchers will track quality of life and patient experiences in 570 adults to see which approach works better. The goal is to help patients and doctors make more informed decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide clear evidence to help patients and doctors choose between bladder removal and medical therapy for recurrent bladder cancer.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove one treatment is better. It also relies on patient-reported outcomes, which can vary widely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

570 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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. Patient Eligibility, 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.

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Conditions

The condition(s) this trial relates to.

neoplasm Neoplasms by Site non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms Recurrence urinary bladder carcinoma urinary bladder disorder Urinary Bladder Neoplasms urinary system disorder Urogenital Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer Cancer of the bladder, recurrent Non-muscle invasive bladder cancer

Contacts and locations

Locations

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461, United States

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572, United States

  • Chesapeake Urology Research Associates

    Hanover, Maryland, 21076, United States

  • Comprehensive Urology -- A Division of Michigan Healthcare Professionals

    Royal Oak, Michigan, 48073, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612, United States

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Johns Hopkins University, School of Medicine

    Baltimore, Maryland, 21231, United States

  • LSU Healthcare Network - Multi Specialty Clinic

    Metairie, Louisiana, 70006, United States

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic Cancer Center

    Phoenix, Arizona, 85054, United States

  • Michigan Medicine Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19122, United States

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73114, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • USC/Norris Comprehensive CA Center

    Los Angeles, California, 90033, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.