A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 17
- Primary Endpoint
- Disease-Free Survival (DFS)
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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
Arms & Interventions
NMIBC Participants: Routine Clinical Practice Setting
Participants with confirmed diagnosis of NMIBC and who have initiated first dose of TAR-200 in a real-world clinical setting, within 6 weeks prior to baseline visit/Study visit 1 will be observed for 24 months from the initiation of the first dose of TAR-200, or until the participant dies, is lost to follow-up, or withdraws consent in the study. No intervention will be administered as a part of this study.
Outcomes
Primary Outcomes
Disease-Free Survival (DFS)
Time Frame: Up to 24 months
DFS is defined as the time from first TAR-200 initiation date to the time of the first recurrence of NMIBC (Ta, any T1 or carcinoma in-situ \[CIS)\], progression (to muscle invasive bladder cancer \[MIBC; T greater than or equal to {\>=} 2\] or to lymph node \[N+\] or to distant disease \[M+\], whichever occurs first), or death due NMIBC, whichever occurs first.
Secondary Outcomes
- Complete Response (CR) Rate(At 3, 6, 12, 18, and 24 months)
- Overall Survival (OS)(Up to 24 months)
- Duration of Response (DOR)(Up to 24 months)
- Study Dropout Rate(Up to 24 months)
- Treatment Adherence: Impact of Follow-up Reminders(Up to 24 months)
- Number of Participants with Radical Cystectomy (RC) /Bladder-Intact Survival(Up to 24 months)
- Time to RC /Bladder-Intact Survival(Up to 24 months)
- Cancer-Specific Survival (CSS)(Up to 24 months)
- Time to Next Treatment (TTNT)(Up to 24 months)
- Number of Participants with Adverse Events (AEs)(Up to 24 months)
- Treatment Patterns for TAR-200(Up to 24 months)
- Time to TAR-200 Discontinuation(Up to 24 months)
- DFS After Re-Treatment with TAR-200(Up to 24 months)
- CR Rate After Re-treatment with TAR-200(Up to 24 months)
- DOR After Re-Treatment with TAR-200(Up to 24 months)
- OS After Re-Treatment with TAR-200(Up to 24 months)
- CSS After Re-Treatment with TAR-200(Up to 24 months)
- TTNT After Re-Treatment with TAR-200(Up to 24 months)
- Number of Participants with Radical cystectomy/ Bladder-Intact Survival After Re-Treatment with TAR-200(Up to 24 months)
- Time to RC /Bladder-Intact Survival After Re-Treatment with TAR-200(Up to 24 months)