Recruiting

Urine test to predict bladder cancer treatment response

Plain-English translation of NCT04564781 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

Read our Bladder Cancer research guide →

What is this trial?

This trial is testing a new urine-based diagnostic tool designed to predict whether patients will respond well to BCG immunotherapy, a standard treatment for intermediate or high-risk bladder cancer. Currently, doctors cannot tell in advance which patients will benefit from this treatment and which will not — meaning nearly half of patients treated with BCG fail therapy. This study aims to create a simple test using urine samples that could identify responders before treatment begins.

About half of bladder cancer patients treated with this medication do not respond and must undergo additional treatments or even complete bladder removal surgery. A reliable way to predict who will and will not respond to the treatment would help doctors choose the best approach for each patient and avoid unnecessary surgery.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with intermediate or high-grade non-muscle invasive bladder cancer within the past 90 days
you have had all visible tumors removed from your bladder or have had confirmation that no visible tumors remain
you are scheduled to start BCG immunotherapy within the next 4 weeks
you are willing to provide a voided urine sample

You likely don't qualify if…

you have previously received intravesical BCG therapy
you are currently taking oral steroid medications
you have a known history of tuberculosis
you have a current urinary tract infection, urinary retention, or active kidney or bladder stones
you have had recent bladder instrumentation within 7 days or have ureteral stents or nephrostomy tubes

What participation looks like

Participants will provide a urine sample that will be tested with the new diagnostic tool. You will continue with your planned BCG immunotherapy as scheduled. The study will follow your treatment response over time to see how accurately the urine test predicted whether you would benefit from the treatment. You must be willing and able to complete the full BCG treatment course while enrolled.

AI-generated summary from trial data · Jul 11, 2026 · Not medical advice

Trial locations(6 sites)

United States

Cedars-Sinai Medical Center, Los Angeles, California

UCLA, Los Angeles, California

UCSF, San Francisco, California

University of Texas Southwestern, Dallas, Texas

Australia

University of Queensland, Brisbane