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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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 groups in NCT06026332
Study groupRoleWhat they receive
ADSTILADRINNot described
Receives: Drug: ADSTILADRIN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)

  1. 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

  2. High-grade recurrence-free survival

    Measured: Up to 2 years

  3. Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation

    Measured: 1 year

  4. Incidence of and time to cystectomy

    Measured: Up to 2 years

  5. Progression-free survival (PFS)

    Measured: Up to 2 years

  6. Overall Survival (OS)

    Measured: Up to 2 years

  7. Mortality due to bladder cancer

    Measured: Up to 2 years

  8. Prior treatments and outcomes before starting ADSTILADRIN treatment

    Measured: Before starting ADSTILADRIN treatment

  9. Number of ADSTILADRIN instillations received and time intervals between instillations

    Measured: Up to 2 years

  10. Reasons for discontinuation of ADSTILADRIN treatment

    Measured: End of trial (up to 2 years)

  11. Concomitant therapies for bladder cancer and major comorbidities

    Measured: Up to 2 years

  12. Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician

    Measured: 3 months

  13. 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

  14. Subsequent line of therapy following ADSTILADRIN discontinuation

    Measured: Up to 2 years

  15. 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

  16. Quality of life surveys (EQ-5D-5L before first ADSTILADRIN instillation)

    Measured: Before first ADSTILADRIN instillation

  17. 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

  18. 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)

  19. 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.

  1. First posted7 Sep 2023
  2. Study start15 Sep 2023
  3. Primary completion15 Jan 2026
  4. 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

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)
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

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?

On the ClinicalTrials.gov record for NCT06026332.

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.

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