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

White River Junction Veterans Affairs Medical Center

Status: Enrolling

Conditions: Non-muscle-invasive Bladder Cancer

Treatments: Diagnostic Test: Bladder EpiCheck urine test; Procedure: Cystoscopy; Diagnostic Test: Xpert Bladder Cancer Monitor urine test

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT05796375

R37CA275916 (U.S. NIH Grant/Contract)

1732756

1R37CA275916-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with urine testing. Specifically, this study examines whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.

Full description

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 years or older

2. History of low grade intermediate-risk non-muscle invasive bladder cancer, defined as most recent pathology report showing any of the following:

   • multifocal low grade non-invasive urothelial carcinoma of any size
   • solitary low grade non-invasive urothelial carcinoma greater than 3cm in size
   • recurrent low grade non-invasive urothelial carcinoma

3. Stated willingness to comply with all study procedures and availability for the duration of the study

4. No evidence for recurrence at cystoscopy ≤4 months after most recent tumor resection

5. Ability to consent in English or Spanish

Exclusion criteria

1. History of total cystectomy of the bladder.
2. History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit).
3. History of muscle-invasive bladder tumor.
4. Pregnancy or lactation.
5. History of urothelial carcinoma of the ureter or renal pelvis status post endoscopic treatment or with evidence of recurrent upper tract disease (inclusion allowed if status post nephroureterectomy and recurrence free at time of inclusion)
6. Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).
7. Inability to provide a voided urine sample.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Frequent Cystoscopy

Active Comparator group

Description:

Cystoscopy is conducted at 6, 12, 18, and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer

Treatment:

Procedure: Cystoscopy

Xpert Urine Test

Experimental group

Description:

Xpert arm includes urine testing using the Xpert Bladder Cancer Monitor urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer

Treatment:

Diagnostic Test: Xpert Bladder Cancer Monitor urine test

Procedure: Cystoscopy

EpiCheck Urine Text

Experimental group

Description:

EpiCheck arm includes urine testing using the Bladder EpiCheck urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer.

Treatment:

Procedure: Cystoscopy

Diagnostic Test: Bladder EpiCheck urine test