ADSTILADRIN Early Utilization and Outcomes in the Real World Setting

NCT ID: NCT06026332

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-15

Study Completion Date

2027-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ADSTILADRIN

ADSTILADRIN

Intervention Type DRUG

Non-interventional

Interventions

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ADSTILADRIN

Non-interventional

Intervention Type DRUG

Other Intervention Names

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Nadofaragene Firadenovec

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Banner Health MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status RECRUITING

Mayo Clinic Arizona

Phoenix, Arizona, United States

Site Status RECRUITING

Arkansas Urology, North Little Rock

Little Rock, Arkansas, United States

Site Status RECRUITING

Urology Associates of Central California

Fresno, California, United States

Site Status RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

UF Health Surgical Specialists - Gainesville

Gainesville, Florida, United States

Site Status RECRUITING

Mayo Clinic

Jacksonville, Florida, United States

Site Status RECRUITING

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status RECRUITING

Florida Urology Partners

Riverview, Florida, United States

Site Status RECRUITING

Florida Urology Partners

St. Petersburg, Florida, United States

Site Status RECRUITING

Florida Urology Partners

Tampa, Florida, United States

Site Status RECRUITING

Florida Urology Partners

Tampa, Florida, United States

Site Status RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Georgia Urology

Atlanta, Georgia, United States

Site Status RECRUITING

UROLOGY OF INDIANA - GREENWOOD FQ: Urology of Indiana US Uro Partners

Greenwood, Indiana, United States

Site Status RECRUITING

First Urology Research (Jeffersonville)

Jeffersonville, Indiana, United States

Site Status RECRUITING

Wichita Urology - Wichita Webb

Wichita, Kansas, United States

Site Status RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Mayo Clinic - Rochester Minnesota

Rochester, Minnesota, United States

Site Status RECRUITING

Minnesota Urology

Woodbury, Minnesota, United States

Site Status RECRUITING

The Urology Center, PC

Omaha, Nebraska, United States

Site Status RECRUITING

AMP UROLOGY, Syracuse - US Urology Partners

Syracuse, New York, United States

Site Status RECRUITING

SUNY Upstate Medical University Syracuse

Syracuse, New York, United States

Site Status RECRUITING

Montefiore Medical Center (Bronx2)

The Bronx, New York, United States

Site Status RECRUITING

Central OH Urology Group - US Urology Partners

Gahanna, Ohio, United States

Site Status RECRUITING

Atlantic Urology Clinics - McLeod Health Blvd

Myrtle Beach, South Carolina, United States

Site Status RECRUITING

Urology Associates P C (Nashville)

Nashville, Tennessee, United States

Site Status RECRUITING

University of Texas Southwestern Medical Center (Dallas)

Dallas, Texas, United States

Site Status RECRUITING

University of Utah (Salt Lake City)

Salt Lake City, Utah, United States

Site Status RECRUITING

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status RECRUITING

Urology of Virginia (Virginia Beach)

Virginia Beach, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Global Clinical Compliance

Role: CONTACT

1-888-FERRING (1-888-337-7464)

Global Clinical Compliance

Role: CONTACT

+1 862-286-5200 (outside US)

Facility Contacts

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Global Clinical Compliance

Role: primary

Other Identifiers

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000431

Identifier Type: -

Identifier Source: org_study_id

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