Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance

This is a multi-site randomized phase 2 trial including 240 patients with early-stage

bladder cancer, in which patients will be randomized 1:1:1 to programmatic surveillance

with the Xpert bladder cancer urine test, the Bladder EpiCheck urine test, or frequent

cystoscopy. The primary outcome will be urinary quality of life measured 1 to 3 days

after surveillance.

This study will have three groups, also called "arms": (1) Frequent Cystoscopy Arm, (2)

Xpert Urine Test Arm, and (3) Epicheck Urine Test Arm. The aim of Frequent Cystoscopy is

to detect any cancer that might have come back within the bladder by frequently

inspecting the bladder. Those in the cystoscopy arm will have a cystoscopy procedure at

specified time points for two years. The goal of the Xpert Urine Test arm is to detect

any cancer that might have come back within the bladder, while decreasing the number of

invasive cystoscopy procedures. Those in the Xpert arm will have a Xpert urine test and a

check-up with a medical doctor at 6 months and 18 months, and have a cystoscopy procedure

at 12 months and 24 months. The aim of the EpiCheck Urine Test arm is to detect any

cancer that might have come back within the bladder, while decreasing the number of

invasive cystoscopy procedures. Those in the EpiCheck Urine Test arm will have an

Epicheck urine test and a check-up with a medical doctor at 6 months and 18 months and

will have a cystoscopy procedure at 12 months and 24 months. The study performance period

is 24 months.