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
Brief Title
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-888-FERRING (1-888-337-7464)
Central Contact Email
MedqueriesUS@ferring.com
Central Contact Role
Contact
Central Contact Phone
+1 862-286-5200 (outside US)
Central Contact Email
DK0-Disclosure@ferring.com
Completion Date
Completion Date Type
Estimated
Conditions
Bladder Cancer
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Bladder cancer
NMIBC
CIS
Ta/T1
BCG Unresponsive
Vesical instillation treatment
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06026332
Org Class
Industry
Org Full Name
Ferring Pharmaceuticals
Org Study Id
000431
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
Primary Outcomes
Outcome 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
Outcome Time Frame
3 months
Outcome 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
Outcome Time Frame
1 year
Secondary Outcomes
Outcome Time Frame
Up to 2 years
Outcome Measure
Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR
Outcome Time Frame
Up to 2 years
Outcome Measure
High-grade recurrence-free survival
Outcome Time Frame
1 year
Outcome Measure
Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation
Outcome Time Frame
Up to 2 years
Outcome Measure
Incidence of and time to cystectomy
Outcome Time Frame
Up to 2 years
Outcome Measure
Progression-free survival (PFS)
Outcome Time Frame
Up to 2 years
Outcome Measure
Overall Survival (OS)
Outcome Time Frame
Up to 2 years
Outcome Measure
Mortality due to bladder cancer
Outcome Time Frame
Before starting ADSTILADRIN treatment
Outcome Measure
Prior treatments and outcomes before starting ADSTILADRIN treatment
Outcome Time Frame
Up to 2 years
Outcome Measure
Number of ADSTILADRIN instillations received and time intervals between instillations
Outcome Time Frame
End of trial (up to 2 years)
Outcome Measure
Reasons for discontinuation of ADSTILADRIN treatment
Outcome Time Frame
Up to 2 years
Outcome Measure
Concomitant therapies for bladder cancer and major comorbidities
Outcome Time Frame
3 months
Outcome Measure
Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician
Outcome Description
WPAI:CG is Work Productivity and Activity Impairment, as adapted for caregiving.
Outcome Time Frame
Up to 2 years
Outcome Measure
Patients' caregiver experience as measured by WPAI:CG (administered at the same timepoints as the patients)
Outcome Time Frame
Up to 2 years
Outcome Measure
Subsequent line of therapy following ADSTILADRIN discontinuation
Outcome Time Frame
Before first ADSTILADRIN instillation and before each instillation thereafter
Outcome Measure
Customized patient baseline and follow-up experience surveys (before first ADSTILADRIN instillation and before each instillation thereafter)
Outcome Time Frame
Before first ADSTILADRIN instillation
Outcome Measure
Quality of life surveys (EQ-5D-5L before first ADSTILADRIN instillation)
Outcome Description
Domains captured will include product considerations and treatment satisfaction
Outcome Time Frame
Up to 2 years
Outcome 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)
Outcome Time Frame
End of trial (up to 2 years)
Outcome 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
Outcome Description
Routine care setting e.g., Cxbladder Detec, UroVysion FISH, nuclear matrix protein 22 (NMP22) and bladder tumor antigen (BTA) tests\]
Outcome Time Frame
End of trial (up to 2 years)
Outcome Measure
Proportion of patients with pre-specified biomarker tested in the routine care setting, along with timing, type of sampling and laboratory results
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Participants who have been prescribed Ferring ADSTILADRIN at the participating sites will be enrolled.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alexander Sankin
Investigator Email
asankin@montefiore.org