ADSTILADRIN Early Utilization and Outcomes in the Real World Setting (ABLE-41)

February 12, 2026 updated by: Ferring Pharmaceuticals
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner Health MD Anderson Cancer Center
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Urology, North Little Rock
    • California
      • Fresno, California, United States, 93720
        • Urology Associates of Central California
      • Los Angeles, California, United States, 90033
        • USC Norris Comprehensive Cancer Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • UF Health Surgical Specialists - Gainesville
      • Jacksonville, Florida, United States, 32225
        • Mayo Clinic
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Riverview, Florida, United States, 33578
        • Florida Urology Partners
      • St. Petersburg, Florida, United States, 33701
        • Florida Urology Partners
      • Tampa, Florida, United States, 33615
        • Florida Urology Partners
      • Tampa, Florida, United States, 33607
        • Florida Urology Partners
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University
      • Atlanta, Georgia, United States, 30328
        • Georgia Urology
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • UROLOGY OF INDIANA - GREENWOOD FQ: Urology of Indiana US Uro Partners
      • Jeffersonville, Indiana, United States, 47130
        • First Urology Research (Jeffersonville)
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Wichita Urology - Wichita Webb
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Urology
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • The Urology Center, PC
    • New York
      • Syracuse, New York, United States, 13210
        • AMP UROLOGY, Syracuse - US Urology Partners
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Syracuse
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center (Bronx2)
    • Ohio
      • Gahanna, Ohio, United States, 43230
        • Central OH Urology Group - US Urology Partners
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29579
        • Atlantic Urology Clinics - McLeod Health Blvd
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Urology Associates P C (Nashville)
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center (Dallas)
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah (Salt Lake City)
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia (Virginia Beach)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who have been prescribed Ferring ADSTILADRIN at the participating sites will be enrolled.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ADSTILADRIN
Drug: ADSTILADRIN
Non-interventional
Other Names:
  • Nadofaragene Firadenovec

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 2 years
Up to 2 years
Progression-free survival (PFS)
Time Frame: Up to 2 years
Up to 2 years
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
Up to 2 years
High-grade recurrence-free survival
Time Frame: Up to 2 years
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
1 year
Incidence of and time to cystectomy
Time Frame: Up to 2 years
Up to 2 years
Mortality due to bladder cancer
Time Frame: Up to 2 years
Up to 2 years
Prior treatments and outcomes before starting ADSTILADRIN treatment
Time Frame: Before starting ADSTILADRIN treatment
Before starting ADSTILADRIN treatment
Number of ADSTILADRIN instillations received and time intervals between instillations
Time Frame: Up to 2 years
Up to 2 years
Reasons for discontinuation of ADSTILADRIN treatment
Time Frame: End of trial (up to 2 years)
End of trial (up to 2 years)
Concomitant therapies for bladder cancer and major comorbidities
Time Frame: Up to 2 years
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
3 months
Subsequent line of therapy following ADSTILADRIN discontinuation
Time Frame: Up to 2 years
Up to 2 years
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
Domains captured will include product considerations and treatment satisfaction
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)
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)
Routine care setting e.g., Cxbladder Detec, UroVysion FISH, nuclear matrix protein 22 (NMP22) and bladder tumor antigen (BTA) tests]
End of trial (up to 2 years)
Patients' caregiver experience as measured by WPAI:CG (administered at the same timepoints as the patients)
Time Frame: Up to 2 years
WPAI:CG is Work Productivity and Activity Impairment, as adapted for caregiving.
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
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
Before first ADSTILADRIN instillation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 000431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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