Bladder CancerABLE-41NCT06026332
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
An observational study of Bladder Cancer, run by Ferring Pharmaceuticals at 31 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- ADSTILADRIN
- How many people
- 202 participants
- Where
- 31 sitesUnited States
- Study dates
- 15 Sep 2023to 15 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who have been prescribed Ferring ADSTILADRIN at the participating sites will be enrolled.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Emory University
Atlanta, Georgia, 30308
Georgia Urology
Atlanta, Georgia, 30328
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Texas Southwestern Medical Center (Dallas)
Dallas, Texas, 75390
Urology Associates of Central California
Fresno, California, 93720
Central OH Urology Group - US Urology Partners
Gahanna, Ohio, 43230
UF Health Surgical Specialists - Gainesville
Gainesville, Florida, 32610
Banner Health MD Anderson Cancer Center
Gilbert, Arizona, 85234
UROLOGY OF INDIANA - GREENWOOD FQ: Urology of Indiana US Uro Partners
Greenwood, Indiana, 46143
Mayo Clinic
Jacksonville, Florida, 32225
First Urology Research (Jeffersonville)
Jeffersonville, Indiana, 47130
Arkansas Urology, North Little Rock
Little Rock, Arkansas, 72211
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Atlantic Urology Clinics - McLeod Health Blvd
Myrtle Beach, South Carolina, 29579
Urology Associates P C (Nashville)
Nashville, Tennessee, 37209
The Urology Center, PC
Omaha, Nebraska, 68114
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Florida Urology Partners
Riverview, Florida, 33578
Mayo Clinic - Rochester Minnesota
Rochester, Minnesota, 55905
University of Utah (Salt Lake City)
Salt Lake City, Utah, 84112
Florida Urology Partners
St. Petersburg, Florida, 33701
AMP UROLOGY, Syracuse - US Urology Partners
Syracuse, New York, 13210
SUNY Upstate Medical University Syracuse
Syracuse, New York, 13210
Florida Urology Partners
Tampa, Florida, 33607
Florida Urology Partners
Tampa, Florida, 33615
Montefiore Medical Center (Bronx2)
The Bronx, New York, 10461
Urology of Virginia (Virginia Beach)
Virginia Beach, Virginia, 23462
Wichita Urology - Wichita Webb
Wichita, Kansas, 67226
Minnesota Urology
Woodbury, Minnesota, 55125
About this study
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
- Conditions
- Bladder Cancer
- Being tested
- ADSTILADRIN
- Keywords
- Bladder cancer, NMIBC, CIS, Ta/T1, BCG Unresponsive, Vesical instillation treatment
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADSTILADRINDrug
Also called Nadofaragene Firadenovec
Non-interventional
| Study group | Role | What they receive |
|---|---|---|
| ADSTILADRIN | Not described Receives: Drug: ADSTILADRIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Up to 2 years
High-grade recurrence-free survival
Measured: Up to 2 years
Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation
Measured: 1 year
Incidence of and time to cystectomy
Measured: Up to 2 years
Progression-free survival (PFS)
Measured: Up to 2 years
Overall Survival (OS)
Measured: Up to 2 years
Mortality due to bladder cancer
Measured: Up to 2 years
Prior treatments and outcomes before starting ADSTILADRIN treatment
Measured: Before starting ADSTILADRIN treatment
Number of ADSTILADRIN instillations received and time intervals between instillations
Measured: Up to 2 years
Reasons for discontinuation of ADSTILADRIN treatment
Measured: End of trial (up to 2 years)
Concomitant therapies for bladder cancer and major comorbidities
Measured: Up to 2 years
Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician
Measured: 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.
Measured: Up to 2 years
Subsequent line of therapy following ADSTILADRIN discontinuation
Measured: Up to 2 years
Customized patient baseline and follow-up experience surveys (before first ADSTILADRIN instillation and before each instillation thereafter)
Measured: Before first ADSTILADRIN instillation and before each instillation thereafter
Quality of life surveys (EQ-5D-5L before first ADSTILADRIN instillation)
Measured: 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
Measured: 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
Measured: 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]
Measured: End of trial (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start15 Sep 2023
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026332
- Sponsor's protocol ID
- 000431
- Acronym
- ABLE-41
- Status last verified
- Feb 2026
- First submitted
- 30 Aug 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
- ClinicalTrials.gov ID
- NCT06026332
- Acronym / sponsor ID
- ABLE-41 / 000431
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, NMIBC, CIS, Ta/T1, BCG Unresponsive, Vesical instillation treatment
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADSTILADRIN | – | Drug: ADSTILADRIN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have been prescribed Ferring ADSTILADRIN at the participating sites will be enrolled.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADSTILADRINAlso: Nadofaragene FiradenovecNon-interventional | Drug | ADSTILADRIN |
Primary outcome
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
19 secondary outcomes
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
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)
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)
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
Time frame: End of trial (up to 2 years)
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Ferring Pharmaceuticals at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.