Study on TARA-002 vs. Chemotherapy for Treating High-Grade Non-Muscle Invasive Bladder Cancer
Sponsor: Protara Therapeutics
ClinicalTrials ID:NCT07480356
This clinical trial is testing whether TARA-002 can effectively treat high-grade non-muscle invasive bladder cancer in adults who have not previously received BCG treatment. The study will compare TARA-002 to standard chemotherapy to evaluate its effectiveness and safety.
Patient Parameters
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Program Overview
The purpose of this study is to determine if TARA-002 can help treat high-grade non-muscle invasive bladder cancer (NMIBC) in adults aged 18 and older who have not been treated with BCG before. The study aims to find out if TARA-002 is effective, safe, and what side effects it may have. Researchers will compare the results of TARA-002 with those of standard chemotherapy to see which treatment works better for NMIBC.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Must provide written consent to participate after understanding the study details.
- Must have a confirmed diagnosis of high-grade non-muscle invasive bladder cancer (CIS with or without Ta/T1) that is currently active.
- Must not have received BCG treatment before, or if previously treated, must not have had BCG for at least 24 months before the latest cancer diagnosis, or must have received 2 or fewer doses of BCG in the 24 months before the latest diagnosis.
Exclusion Criteria
- Allergy to penicillin (those with uncertain allergy history will be tested).
- Confirmed different types of bladder cancer.
- Cancer involvement in the prostate or upper urinary tract as assessed by the doctor.
- Any history of cancer that has spread to lymph nodes or other parts of the body.
- Any history of bladder cancer that has reached stage T2 or higher at any time.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| East Valley Urology Center of Arizona | 85140 | Queen Creek | Arizona |
| Arkansas Urology | 72211 | Little Rock | Arkansas |
| Michael Oefelein Clinical Trials | 93301 | Bakersfield | California |
| Renown Regional Medical Center | 63110 | St Louis | Missouri |
| START - Carolinas | 29572 | Myrtle Beach | South Carolina |
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