Clinical trial NCT06026332: ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
Official title: ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Keywords: Bladder cancer
NMIBC
CIS
Ta/T1
BCG Unresponsive
Vesical instillation treatment
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-09-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have been prescribed Ferring ADSTILADRIN at the participating sites will be enrolled.

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Prescribed and scheduled treatment with ADSTILADRIN per physician discretion or received the first instillation of ADSTILADRIN per physician discretion after 5 September 2023 but prior to site activation
* Signed and dated ICF.
* Age 18 years or older at day ICF is signed.

Exclusion Criteria:

* Currently enrolled in a clinical trial.
* Participants who have previously been treated with ADSTILADRIN in the context of a clinical trial
* Participant is pregnant or breastfeeding.

Primary outcomes:
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR
timeFrame: Up to 2 years
measure: High-grade recurrence-free survival
timeFrame: Up to 2 years
measure: Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation
timeFrame: 1 year
measure: Incidence of and time to cystectomy
timeFrame: Up to 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Mortality due to bladder cancer
timeFrame: Up to 2 years
measure: Prior treatments and outcomes before starting ADSTILADRIN treatment
timeFrame: Before starting ADSTILADRIN treatment
measure: Number of ADSTILADRIN instillations received and time intervals between instillations
timeFrame: Up to 2 years
measure: Reasons for discontinuation of ADSTILADRIN treatment
timeFrame: End of trial (up to 2 years)
measure: Concomitant therapies for bladder cancer and major comorbidities
timeFrame: Up to 2 years
measure: Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician
timeFrame: 3 months
measure: Patients' caregiver experience as measured by WPAI:CG (administered at the same timepoints as the patients)
timeFrame: Up to 2 years
measure: Subsequent line of therapy following ADSTILADRIN discontinuation
timeFrame: Up to 2 years
measure: Customized patient baseline and follow-up experience surveys (before first ADSTILADRIN instillation and before each instillation thereafter)
timeFrame: Before first ADSTILADRIN instillation and before each instillation thereafter
measure: Quality of life surveys (EQ-5D-5L before first ADSTILADRIN instillation)
timeFrame: Before first ADSTILADRIN instillation
measure: 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)
timeFrame: Up to 2 years
measure: 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
timeFrame: End of trial (up to 2 years)
measure: Proportion of patients with pre-specified biomarker tested in the routine care setting, along with timing, type of sampling and laboratory results
timeFrame: End of trial (up to 2 years)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Ferring Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Ferring Investigational Site
state: Arkansas
city: Fresno
country: United States
facility: Ferring Investigational Site
state: California
city: Los Angeles
country: United States
facility: Ferring Investigational Site
state: California
city: Gainesville
country: United States
facility: Ferring Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Ferring Investigational Site
state: Georgia
city: Greenwood
country: United States
facility: Ferring Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Ferring Investigational Site
state: Indiana
city: Wichita
country: United States
facility: Ferring Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: Ferring Investigational Site
state: Maryland
city: Rochester
country: United States
facility: Ferring Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: Ferring Investigational Site
state: Nebraska
city: Bronx
country: United States
facility: Ferring Investigational Site
state: New York
city: New York
country: United States
facility: Ferring Investigational Site
state: New York
city: Syracuse
country: United States
facility: Ferring Investigational Site
state: New York
city: Gahanna
country: United States
facility: Ferring Investigational Site
state: Ohio
city: Myrtle Beach
country: United States
facility: Ferring Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Ferring Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Ferring Investigation Site
state: Texas
city: Charlottesville
country: United States
facility: Ferring Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Ferring Investigational Site
state: Virginia
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: