Clinical trial NCT06525571: Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Official title: Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: Blue light cystoscopy
Cysview
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Photocure ASA
First posted: 2024-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.

Detailed description: Objectives are as follows:

Primary i) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among patients with a high-grade tumor at time of resection ii) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among all evaluable study participants.

Secondary i) Among all evaluable study participants: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.

ii) Among patients undergoing intravesical induction: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing TURBT for radiographic or cystoscopic positive tumor
* 18+ years old
* Upper tract evaluated using standard of care throughout duration of the study
* Induction intravesical therapy initiated within four weeks of TURBT

Exclusion Criteria:

* Variant histology consisting of less than 50% urothelial carcinoma
* History, or current diagnosis, of upper tract tumor or muscle-invasive bladder cancer
* Prior history of pelvic radiation
* Active urinary tract infection (UTI)
* Patients who are noncompliant with the study protocol

Primary outcomes:
measure: Residual disease burden
timeFrame: Up to 24 months
measure: Minimal residual disease burden
timeFrame: Up to 24 months
Secondary outcomes:
measure: Recurrence-free survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Sibley Memorial Hospital
name: Armine Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: