A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non-Muscle Invasive Bladder Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US
Overview
The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free survival) in participants with non-muscle invasive bladder cancer (NMIBC; an early-stage bladder cancer that is limited to the inner lining of bladder).
Primary outcome measures
- Disease-Free Survival (DFS) [Time frame: Up to 24 months]
Secondary outcome measures (12)
- Complete Response (CR) Rate [Time frame: At 3, 6, 12, 18, and 24 months]
- Duration of Response (DOR) [Time frame: Up to 24 months]
- Overall Survival (OS) [Time frame: Up to 24 months]
- Cancer-Specific Survival (CSS) [Time frame: Up to 24 months]
- Time to Next Treatment (TTNT) [Time frame: Up to 24 months]
- Number of Participants with Radical Cystectomy (RC) /Bladder-Intact Survival [Time frame: Up to 24 months]
- Time to RC /Bladder-Intact Survival [Time frame: Up to 24 months]
- Number of Participants with Adverse Events (AEs) [Time frame: Up to 24 months]
- Treatment Patterns for TAR-200 [Time frame: Up to 24 months]
- Time to TAR-200 Discontinuation [Time frame: Up to 24 months]
- Study Dropout Rate [Time frame: Up to 24 months]
- Treatment Adherence: Impact of Follow-up Reminders [Time frame: Up to 24 months]
Eligibility criteria
Inclusion criteria
- Has a confirmed diagnosis of NMIBC based on TURBT or cold cup biopsy
- Initiated first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1
- Participants with childbearing potential are required to adhere to contraceptive recommendations as specified in the approved product labeling for TAR-200. Additionally, participants should seek consultation with their physician for personalized contraceptive advice
- Must provide informed consent as described in the protocol
Exclusion criteria
- Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment
- Had previous treatment with TAR-200 discontinued prior to baseline visit/Study visit 1
- Previously received TAR-200 intravesically as part of a clinical trial(s)
- Previously received greater than (>) 2 doses/cycles of TAR-200 in the real-world setting
- Currently participating in an interventional bladder cancer clinical trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 16 centers
- University of Alabama at Birmingham — Birmingham
- Arkansas Urology — Little Rock
- USC Norris Comprehensive Cancer Center — Los Angeles
- Cedars Sinai Medical Center — Los Angeles
- Colorado Clinical Research — Lakewood
- Florida Urology Partners — Wimauma
- Associated Urological Specialists — Chicago Ridge
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis
- … and 8 more centers
Identifiers
NCT: NCT07309445 · 17000139BLC4004