Study Stopped
An internal audit identified major inconsistencies and missing data in key registry fields, including primary outcomes. These issues mean we can no longer ensure the validity of the primary endpoints.
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
ABLE-41
1 other identifier
observational
202
1 country
31
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Typical duration for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2023
CompletedFirst Posted
Study publicly available on registry
September 7, 2023
CompletedStudy Start
First participant enrolled
September 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2026
CompletedFebruary 17, 2026
February 1, 2026
2.3 years
August 30, 2023
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
1 year
Secondary Outcomes (19)
Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR
Up to 2 years
High-grade recurrence-free survival
Up to 2 years
Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation
1 year
Incidence of and time to cystectomy
Up to 2 years
Progression-free survival (PFS)
Up to 2 years
- +14 more secondary outcomes
Study Arms (1)
ADSTILADRIN
Interventions
Eligibility Criteria
Participants who have been prescribed Ferring ADSTILADRIN at the participating sites will be enrolled.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Banner Health MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Arkansas Urology, North Little Rock
Little Rock, Arkansas, 72211, United States
Urology Associates of Central California
Fresno, California, 93720, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UF Health Surgical Specialists - Gainesville
Gainesville, Florida, 32610, United States
Mayo Clinic
Jacksonville, Florida, 32225, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Florida Urology Partners
Riverview, Florida, 33578, United States
Florida Urology Partners
St. Petersburg, Florida, 33701, United States
Florida Urology Partners
Tampa, Florida, 33607, United States
Florida Urology Partners
Tampa, Florida, 33615, United States
Emory University
Atlanta, Georgia, 30308, United States
Georgia Urology
Atlanta, Georgia, 30328, United States
UROLOGY OF INDIANA - GREENWOOD FQ: Urology of Indiana US Uro Partners
Greenwood, Indiana, 46143, United States
First Urology Research (Jeffersonville)
Jeffersonville, Indiana, 47130, United States
Wichita Urology - Wichita Webb
Wichita, Kansas, 67226, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Mayo Clinic - Rochester Minnesota
Rochester, Minnesota, 55905, United States
Minnesota Urology
Woodbury, Minnesota, 55125, United States
The Urology Center, PC
Omaha, Nebraska, 68114, United States
AMP UROLOGY, Syracuse - US Urology Partners
Syracuse, New York, 13210, United States
SUNY Upstate Medical University Syracuse
Syracuse, New York, 13210, United States
Montefiore Medical Center (Bronx2)
The Bronx, New York, 10461, United States
Central OH Urology Group - US Urology Partners
Gahanna, Ohio, 43230, United States
Atlantic Urology Clinics - McLeod Health Blvd
Myrtle Beach, South Carolina, 29579, United States
Urology Associates P C (Nashville)
Nashville, Tennessee, 37209, United States
University of Texas Southwestern Medical Center (Dallas)
Dallas, Texas, 75390, United States
University of Utah (Salt Lake City)
Salt Lake City, Utah, 84112, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Urology of Virginia (Virginia Beach)
Virginia Beach, Virginia, 23462, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Compliance
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2023
First Posted
September 7, 2023
Study Start
September 15, 2023
Primary Completion
January 15, 2026
Study Completion
January 15, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share