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New bladder cancer therapy shows promise in early trial

NCT ID NCT05951179

Disease control Sponsor: Protara Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 5 times

Summary

This phase 2 study is testing a new treatment called TARA-002 for people with a type of high-grade bladder cancer that hasn't spread into the muscle. The treatment is given directly into the bladder through a catheter once a week for 6 weeks. The study will include about 131 adults, some who have had prior BCG therapy and some who haven't. The main goal is to see if TARA-002 can make the cancer disappear completely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TARA-002 (a bacterial-based therapy given directly into the bladder)
What this could lead to
If successful, this could offer a new treatment option for people with high-grade bladder cancer that hasn't spread into the muscle, potentially helping to control the disease without needing to remove the bladder.
What could go wrong
This is a phase 2 trial, so it's still early. The treatment may not work for everyone, and side effects from the bladder instillations are possible. Results need to be confirmed in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 131 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female participants 18 years of age or older at the time of signing informed consent * Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry * Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease * Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with CIS (± Ta/T1) who are BCG unresponsive. Exclusion Criteria: * Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory * Central confirmed variant histology * Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment * Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past) * Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history For more information on eligibility criteria, please contact the Sponsor

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ in situ carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-muscle invasive bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    67 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AccuMed Research Associates

    TERMINATED

    Garden City, New York, 11530, United States

  • Advanced Urology

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • AdventHealth Medical Group Urology of Denver

    RECRUITING

    Denver, Colorado, 80211, United States

  • Amarillo Urology Research

    WITHDRAWN

    Amarillo, Texas, 79106, United States

  • Arensia Kapitanivka - PPDS

    RECRUITING

    Kapitanivka, 08111, Ukraine

  • Arkansas Urology

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Associated Medical Professionals of NY, PLLC

    RECRUITING

    Syracuse, New York, 13210, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CEMAIC

    RECRUITING

    Córdoba, X5088, Argentina

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Centro Argentino de Urologia

    RECRUITING

    CABA, C1419, Argentina

  • Centro Urologico Profesor Bengio SA

    RECRUITING

    Córdoba, X5000KPH, Argentina

  • Centro de Urologia Avancada

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Cleveland Clinic Main Campus, Cleveland

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Privada Independencia

    RECRUITING

    Munro, 1605, Argentina

  • Clinical Trial Network

    WITHDRAWN

    Houston, Texas, 77074, United States

  • Colorado University - Anshutz

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Comprehensive Urologic Care

    RECRUITING

    Lake Barrington, Illinois, 60010, United States

  • Conrad Person Clinic

    RECRUITING

    Memphis, Tennessee, 38128, United States

  • East Valley Urology Center of Arizona

    RECRUITING

    Queen Creek, Arizona, 85140, United States

  • Exdeo Clinical Research Inc

    TERMINATED

    Abbotsford British Columbia, British Columbia, V2T 1X8, Canada

  • Faculdade de Medicina ABC-CEPHO

    RECRUITING

    Santo André, São Paulo, 09060-650, Brazil

  • Fuji City General Hospital

    RECRUITING

    Sakura-shi, Chiba, 285-8741, Japan

  • Funabashi Municipal Medical Center

    RECRUITING

    Funabashi-shi, Chiba, 273-8588, Japan

  • Genesis Research

    WITHDRAWN

    San Diego, California, 92123, United States

  • Genesis Research LLC

    RECRUITING

    Torrance, California, 90505, United States

  • Greater Boston Urology, LLC

    RECRUITING

    Plymouth, Massachusetts, 02360, United States

  • Hitachi General Hospital

    RECRUITING

    Hitachi-shi, Ibaraki, 317-0077, Japan

  • Hospital Britanico de Buenos Aires

    RECRUITING

    Buenos Aires, C1280, Argentina

  • Hospital Italiano de Buenos Aires (HIBA)

    RECRUITING

    Buenos Aires, C1199ABB, Argentina

  • Hospital Sirio Libanes

    RECRUITING

    CABA, C1419, Argentina

  • Hospital de Clinicas da UNICAMP

    RECRUITING

    Campinas, São Paulo, 13083-970, Brazil

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Houston Metro Urology

    RECRUITING

    Houston, Texas, 77027, United States

  • Hyogo Prefectural Amagasaki General Medical Center

    RECRUITING

    Amagasaki-shi, Hyōgo, 660-8550, Japan

  • Instituto Dor de Pesquisa e Ensino

    RECRUITING

    Jardim Paulista, São Paulo, 01401-002, Brazil

  • Japanese Red Cross Aichi Medical Center Nayoya Daiichi

    RECRUITING

    Nagoya, Aichi-ken, 435-8511, Japan

  • Japanese Red Cross Osaka Hospital

    RECRUITING

    Osaka, Osaka, 543-855, Japan

  • Jonathan Giddes Medicine Professional Corporation

    WITHDRAWN

    Brampton, Ontario, L6T 4S5, Canada

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, Kanagawa, 807561, Taiwan

  • Komaki City Hospital

    RECRUITING

    Komaki-shi, Aichi-ken, 485-0044, Japan

  • Kyushu University Hospital

    RECRUITING

    Nova Lima, Minas Gerais, 34006-059, Brazil

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, Fukuoka, 812-8582, Japan

  • Laura & Isaac Perlmutter Cancer Center - NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Mayo Clinic

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Michael Oefelein Clinical Trials

    RECRUITING

    Bakersfield, California, 93301, United States

  • Minnesota Urology, Woodbury

    RECRUITING

    Bloomington, Minnesota, 55425, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Niigata Cancer Center Hospital

    RECRUITING

    Niigata, Niigata, 961-8566, Japan

  • Nucleo de Pesquisa Clinica do Rio Grande so Sul

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

  • Ochsner Health LSU - Regional Urology

    WITHDRAWN

    Shreveport, Louisiana, 71105, United States

  • Office of Lucas Nougeria MA

    RECRUITING

    Nova Lima, Minas Gerais, 34006-059, Brazil

  • Renown Regional Medical Center

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Santa Casa de Misericordia de Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-070, Brazil

  • Southern Urology

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • Specialty Clinic Research of St. Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Spokane Urology

    RECRUITING

    Spokane, Washington, 99202, United States

  • Sunnybrook Research Institute

    WITHDRAWN

    Toronto, Ontario, M4N 3M5, Canada

  • The Research Institute of the McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H3H 2R9, Canada

  • Toho University Medical Center Sakura Hospital

    RECRUITING

    Fuji-shi, Shizuoka, 417-8567, Japan

  • Toyama University Hospital

    RECRUITING

    Toyama, Toyama, 930-0152, Japan

  • UHN Princess Margaret Cancer Centre Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 1Z5, Canada

  • UT Health San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of California Irvine Medical Center

    RECRUITING

    Orange, California, 92697, United States

  • University of Florida Health Jacksonville

    WITHDRAWN

    Gainesville, Florida, 32611, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester, Department of Urology

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Toledo

    WITHDRAWN

    Toledo, Ohio, 43606, United States

  • Urology Associates PC

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • Urology Associates of Denver

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • Urology Austin, LLC

    RECRUITING

    Austin, Texas, 78745, United States

  • Urology Centers of Alabama

    RECRUITING

    Homewood, Alabama, 35209, United States

  • Urology Group of Southern California

    TERMINATED

    Los Angeles, California, 90017, United States

  • Urology Partners of North Texas

    RECRUITING

    Arlington, Texas, 76017, United States

  • Virginia Urology

    RECRUITING

    Richmond, Virginia, 23235, United States

  • Yokohama Municipal Citizen's Hospital

    RECRUITING

    Yokohama, Kanagawa, 221-0855, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.