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

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: Terminated
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: ADSTILADRIN

• Study Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ADSTILADRIN	Drug: ADSTILADRIN; Non-interventional; Other Names: Nadofaragene Firadenovec

What is the study measuring?

Primary Outcome Measures

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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)		Up to 2 years
Progression-free survival (PFS)		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		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
Mortality due to bladder cancer		Up to 2 years
Prior treatments and outcomes before starting ADSTILADRIN treatment		Before starting ADSTILADRIN treatment
Number of ADSTILADRIN instillations received and time intervals between instillations		Up to 2 years
Reasons for discontinuation of ADSTILADRIN treatment		End of trial (up to 2 years)
Concomitant therapies for bladder cancer and major comorbidities		Up to 2 years
Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician		3 months
Subsequent line of therapy following ADSTILADRIN discontinuation		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)	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		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]	End of trial (up to 2 years)
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.	Up to 2 years
Customized patient baseline and follow-up experience surveys (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)		Before first ADSTILADRIN instillation

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): January 15, 2026
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Bladder cancer; NMIBC; CIS; BCG Unresponsive; Ta/T1; Vesical instillation treatment
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms
• Other Study ID 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