Multi-center, prospective non-interventional study to collect data on the early use of Adstiladrin in the US and Israel. Data will be collected from patients and prescribing physicians in a real-world setting
Study Type
OBSERVATIONAL
Enrollment
400
Non-interventional
Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves Complete Response (CR) at first evaluation from first ADSTILADRIN instillation
Time frame: 3 months
Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves CR at any time within 1 year from first ADSTILADRIN instillation
Time frame: 1 year
Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR
Time frame: Up to 2 years
High-grade recurrence-free survival
Time frame: Up to 2 years
Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation
Time frame: 1 year
Incidence of and time to cystectomy
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Mortality due to bladder cancer
Time frame: Up to 2 years
Prior treatments and outcomes before starting ADSTILADRIN treatment
Time frame: Before starting ADSTILADRIN treatment
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Banner Health MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGMayo Clinic Arizona
Phoenix, Arizona, United States
RECRUITINGArkansas Urology, North Little Rock
Little Rock, Arkansas, United States
RECRUITINGUrology Associates of Central California
Fresno, California, United States
RECRUITINGUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGUF Health Surgical Specialists - Gainesville
Gainesville, Florida, United States
RECRUITINGMayo Clinic
Jacksonville, Florida, United States
RECRUITINGMount Sinai Medical Center
Miami Beach, Florida, United States
RECRUITINGFlorida Urology Partners
Riverview, Florida, United States
RECRUITINGFlorida Urology Partners
St. Petersburg, Florida, United States
RECRUITING...and 21 more locations
Number of ADSTILADRIN instillations received and time intervals between instillations
Time frame: Up to 2 years
Reasons for discontinuation of ADSTILADRIN treatment
Time frame: End of trial (up to 2 years)
Concomitant therapies for bladder cancer and major comorbidities
Time frame: Up to 2 years
Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician
Time frame: 3 months
Patients' caregiver experience as measured by WPAI:CG (administered at the same timepoints as the patients)
WPAI:CG is Work Productivity and Activity Impairment, as adapted for caregiving.
Time frame: Up to 2 years
Subsequent line of therapy following ADSTILADRIN discontinuation
Time frame: Up to 2 years
Customized patient baseline and follow-up experience surveys (before first ADSTILADRIN instillation and before each instillation thereafter)
Time frame: Before first ADSTILADRIN instillation and before each instillation thereafter
Quality of life surveys (EQ-5D-5L before first ADSTILADRIN instillation)
Time frame: Before first ADSTILADRIN instillation
Customized physician surveys (at 1 month following first patient first instillation of ADSTILADRIN, or as soon as possible upon site activation, and at 12 and 24 months post first patient first instillation at each respective site)
Domains captured will include product considerations and treatment satisfaction
Time frame: Up to 2 years
Type, incidence, relatedness to ADSTILADRIN, severity grading (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), and seriousness of adverse events collected
Time frame: End of trial (up to 2 years)
Proportion of patients with pre-specified biomarker tested in the routine care setting, along with timing, type of sampling and laboratory results
Routine care setting e.g., Cxbladder Detec, UroVysion FISH, nuclear matrix protein 22 (NMP22) and bladder tumor antigen (BTA) tests\]
Time frame: End of trial (up to 2 years)