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NCT05714202Active, not recruitingPhase 3

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1135 (actual)
First submitted
27 Jan 2023
Start date
23 Mar 2023
Primary completion date
18 Sept 2029
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05714202
EU CT number
2023-507187-39-00
EudraCT number
2020-004506-64

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1135
  • From 23 Mar 2023 to the primary completion date, 18 Sept 2029
  • 224 sites in 21 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization

Other illness

  • Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to \[\>=\] T2)
  • A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL)

Other

  • Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded
  • Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Who the study is looking for

  • Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ \[CIS\]), in participants who are Bacillus Calmette Guérin (BCG)-naïve
  • BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)
  • All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma \[HGUC\]) for patients with papillary only disease (without CIS)
  • Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
  • All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (\<) 2 prior to date of randomization
  • Participants must be willing to undergo all study procedures

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (224)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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Buenos AiresArgentinaUnknown status
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaUnknown status
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
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CórdobaArgentinaUnknown status
Centro Urológico Profesor Bengió
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CórdobaArgentinaUnknown status
Hospital Privado Centro Medico de Cordoba
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CórdobaArgentinaUnknown status
Hospital Privado de la Comunidad
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Mar del PlataArgentinaUnknown status
Instituto Médico Río Cuarto
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Río CuartoArgentinaUnknown status
Austin Health
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HeidelbergAustraliaUnknown status
Macquarie University Hospital
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Macquarie UniversityAustraliaUnknown status
Hollywood Private Hospital
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NedlandsAustraliaUnknown status
Mater Hospital Brisbane
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South BrisbaneAustraliaUnknown status
Ziekenhuis Aan De Stroom
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AntwerpBelgiumActive, not recruiting
AZ ST-JAN Brugge A.V.
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BruggeBelgiumActive, not recruiting
A.Z. Sint-Lucas
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BruggeBelgiumActive, not recruiting
Az Maria Middelares Gent
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GentBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
Vivalia
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Libramont-ChevignyBelgiumActive, not recruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumActive, not recruiting
Vitaz
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Sint-NiklaasBelgiumActive, not recruiting
Fundacao Pio XII
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BarretosBrazilUnknown status
NAIC Nair Antunes Instituto do Cancer
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BauruBrazilUnknown status
Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
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CampinasBrazilUnknown status
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
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CuritibaBrazilUnknown status
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilUnknown status
Hospital Regional do Cancer Hospital de Esperanca
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Presidente PrudenteBrazilUnknown status
IDOR - Regional Bahia
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SalvadorBrazilUnknown status
Hospital Ana Nery Santa Cruz do Sul
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Santa Cruz do SulBrazilUnknown status
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
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Santo AndréBrazilUnknown status
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilUnknown status
Real e Benemerita Associacao Portuguesa de Beneficencia
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São PauloBrazilUnknown status
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São PauloBrazilUnknown status
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
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São PauloBrazilUnknown status
Nova Scotia Health Authority
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HalifaxCanadaUnknown status
St. Josephs Healthcare Hamilton
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HamiltonCanadaUnknown status
CHUM - Centre hospitalier universitaire de Montreal
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MontrealCanadaUnknown status
CHU de Quebec -Universite Laval Hopital de L'Enfant-Jesus
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QuébecCanadaUnknown status
Unite de Recherche Clinique du CISSS des Laurentides
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Saint Jerome QuebecCanadaUnknown status
Princess Margaret Cancer Centre - University Health Network
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TorontoCanadaUnknown status
Beijing Luhe Hospital, Capital Medical University
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BeijingChinaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Beijing Hospital
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BeijingChinaUnknown status
The First Bethune Hospital of Jilin University
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ChangchunChinaUnknown status
Hunan Province Cancer Hospital
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ChangshaChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
People's hospital of Deyang city
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DeyangChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
Zhejiang Provincial People's Hospital
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
The First Affiliated Hospital of Ningbo University
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NingboChinaUnknown status
Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
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ShanghaiChinaUnknown status
Huadong Hospital Affiliated to Fudan University
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
The Second Hospital of Tianjin Medical University
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TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
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WuhanChinaUnknown status
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'anChinaUnknown status
Yantai Yuhuangding Hospital
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YantaiChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Fakultni Nemocnice U Sv Anny V Brne
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Brno-StredCzechiaActive, not recruiting
Krajska nemocnice Liberec a.s.
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Liberec (neclenene Mesto)CzechiaActive, not recruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
University Hospital Olomouc
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OlomoucCzechiaActive, not recruiting
Fakultni Nemocnice Motol a Homolka
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PragueCzechiaActive, not recruiting
Fakultní Nemocnice Královské Vinohrady
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Prague 10CzechiaActive, not recruiting
Fakultni Thomayerova nemocnice
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Prague 4CzechiaActive, not recruiting
Urologicum Duisburg
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DuisburgGermanyActive, not recruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyActive, not recruiting
Universitaetsklinikum Frankfurt AöR
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Frankfurt Am MainGermanyActive, not recruiting
Urologische Partnerschaft Köln
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KoelnGermanyActive, not recruiting
Urologie Neandertal - Praxis Mettmann
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MettmannGermanyActive, not recruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyActive, not recruiting
Klinikum rechts der Isar der TU Muenchen AöR
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MunichGermanyActive, not recruiting
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
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NuertingenGermanyActive, not recruiting
Klinikum Nuernberg
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NurembergGermanyActive, not recruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital Punta de Europa
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AlgecirasSpainActive, not recruiting
Fundació Puigvert
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BarcelonaSpainActive, not recruiting
Hospital Universitario Puerta del Mar
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CadizSpainActive, not recruiting
Hospital General Universitario De Castellon
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Castello De La PlanaSpainActive, not recruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainActive, not recruiting
Hospital Universitario Lucus Augusti
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LugoSpainActive, not recruiting
Clinica Universidad de Navarra
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
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ValenciaSpainActive, not recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceActive, not recruiting
Polyclinique De Limoges
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Limoges Cedex IFranceActive, not recruiting
Hospital Edouard Herriot
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Lyon Cedex 03FranceActive, not recruiting
Hospital Hotel Dieu
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NantesFranceActive, not recruiting
Centre Hospitalier Universitaire de Nîmes
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NîmesFranceActive, not recruiting
Centre Hospitalier Universitaire D Orleans
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Orleans Cedex 2FranceActive, not recruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon
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ParisFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceActive, not recruiting
Capio La Croix Du Sud
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Quint-FonsegrivesFranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
Western General Hospital
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EdinburghUnited KingdomUnknown status
The Royal Marsden NHS Trust
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LondonUnited KingdomUnknown status
Charing Cross Hospital
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LondonUnited KingdomUnknown status
St Bartholomews Hospital
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LondonUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Scunthorpe General Hospital
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ScunthorpeUnited KingdomUnknown status
Sheffield Teaching Hospitals NHS Foundation Trust
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SheffieldUnited KingdomUnknown status
Lister Hospital
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StevenageUnited KingdomUnknown status
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
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TruroUnited KingdomUnknown status
Health Care Global Enterprises pvt Ltd
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BangaloreIndiaUnknown status
Post Graduate Institute of Medical Education and Research (PGIMER)
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ChandigarhIndiaUnknown status
Artemis Hospital
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GurugramIndiaUnknown status
Netaji Subhas chandra Bose Cancer Research Institute
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KolkataIndiaUnknown status
Tata Memorial Hospital
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MumbaiIndiaUnknown status
CIMET's Inamdar Multispeciality Hospital
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PuneIndiaUnknown status
AORN San Giuseppe Moscati Avellino
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AvellinoItalyActive, not recruiting
Istituto Oncologico Veneto
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Castelfranco VenetoItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
Fuji City General Hospital
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Fuji-shiJapanUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
Nara Medical University Hospital
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Kashihara-shiJapanUnknown status
Kimitsu Chuo Hospital
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Kisarazu-shiJapanUnknown status
Kobe City Medical Center General Hospital
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KobeJapanUnknown status
National Hospital Organization Kumamoto Medical Center
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KumamotoJapanUnknown status
Nagano Municipal Hospital
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NaganoJapanUnknown status
Nagasaki University Hospital
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NagasakiJapanUnknown status
JRC Nagasaki Genbaku Hospital
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NagasakiJapanUnknown status
Saiseikai Narashino Hospital
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Narashino-shiJapanUnknown status
Ehime University Hospital
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Toon-shiJapanUnknown status
Toyama University Hospital
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ToyamaJapanUnknown status
Yamaguchi University Hospital
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UbeJapanUnknown status
Yokohama City University Medical Center
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YokohamaJapanUnknown status
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
Keimyung University Dongsan Hospital
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DaeguSouth KoreaUnknown status
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaUnknown status
National Cancer Center
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Gyeonggi-doSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Eme Red Hospitalaria
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MéridaMexicoUnknown status
Consultorio Medico dentro del Hospital Angeles Acoxpa
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Mexico CityMexicoUnknown status
Hospital Universitario Dr. Jose Eleuterio González
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MonterreyMexicoUnknown status
Avix Investigación Clínica, S.C.
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MonterreyMexicoUnknown status
Oncologico Potosino
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San Luis Potosí CityMexicoUnknown status
Spaarne Gasthuis Stichting
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HoofddorpNetherlandsActive, not recruiting
Canisius-Wilhelmina Hospital
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NijmegenNetherlandsActive, not recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandActive, not recruiting
In- Vivo Sp. z o. o.
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BydgoszczPolandActive, not recruiting
Provita Centrum Medyczne Sp. z o.o.
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Piotrkow TrybunalskiPolandActive, not recruiting
Clinical Research Center Sp z o o Medic R Sp k
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PoznanPolandActive, not recruiting
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
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SlupskPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Provita Poliklinika sp. z o.o
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WarsawPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandActive, not recruiting
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
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CoimbraPortugalActive, not recruiting
Hospital De Santa Maria E.P.E.
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LisbonPortugalActive, not recruiting
Centro Hospitalar de Vila Nova de Gaia Espinho E P E
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Vila Nova de GaiaPortugalActive, not recruiting
Chang Kung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status
University of Michigan
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Ann ArborUnited StatesUnknown status
The Emory Clinic Department of Urology
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AtlantaUnited StatesUnknown status
Grady Memorial Hospital
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AtlantaUnited StatesUnknown status
Urology Austin
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AustinUnited StatesUnknown status
Centers for Advanced Urology LLC d b a MidLantic Urology
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Bala-CynwydUnited StatesUnknown status
Lahey Hospital & Medical Center
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BurlingtonUnited StatesUnknown status
Cooper Health System MD Anderson Cancer Center at Cooper
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CamdenUnited StatesUnknown status
Urology of Indiana
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CarmelUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Urology Clinics of North Texas
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DallasUnited StatesUnknown status
Central Ohio Urology Group
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GahannaUnited StatesUnknown status
Vidant Urology - Greenville
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GreenvilleUnited StatesUnknown status
Chesapeake Urology Research Associates
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HanoverUnited StatesUnknown status
Urological Research Network
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HialeahUnited StatesUnknown status
Houston Metro Urology
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HoustonUnited StatesUnknown status
Houston Methodist Hospital
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HoustonUnited StatesUnknown status
First Urology
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JeffersonvilleUnited StatesUnknown status
Colorado Clinical Research
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LakewoodUnited StatesUnknown status
Duly Health and Care
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LisleUnited StatesUnknown status
Arkansas Urology
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Little RockUnited StatesUnknown status
VA Long Beach Health Care System
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Long BeachUnited StatesUnknown status
Genesis Research, LLC - West Coast Urology
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Los AlamitosUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
AMR Kansas City Oncology
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MerriamUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
Carolina Urologic Research Center
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Myrtle BeachUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Urology Associates
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NashvilleUnited StatesUnknown status
VA NY Harbor Healthcare System
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mt. Sinai
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New YorkUnited StatesUnknown status
The Urology Center, PC
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OmahaUnited StatesUnknown status
Orlando Health Cancer Institute
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OrlandoUnited StatesUnknown status
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesUnknown status
UPMC-Shadyside Hospital
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PittsburghUnited StatesUnknown status
Blessing Hospital
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QuincyUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
UC Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
George E. Wahlen VAMC
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Salt Lake CityUnited StatesUnknown status
Huntsman Cancer Institute
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Salt Lake CityUnited StatesUnknown status
Urology San Antonio Research
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San AntonioUnited StatesUnknown status
Genesis Research
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San DiegoUnited StatesUnknown status
Providence Saint Johns Cancer Institute
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Santa MonicaUnited StatesUnknown status
Providence Medical Foundation
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Santa RosaUnited StatesUnknown status
Sarasota Memorial Hospital
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SarasotaUnited StatesUnknown status
Mayo Clinic
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ScottsdaleUnited StatesUnknown status
Spokane Urology
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SpokaneUnited StatesUnknown status
Associated Medical Professionals of NY
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SyracuseUnited StatesUnknown status
SUNY Upstate Med Univ
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SyracuseUnited StatesUnknown status
Urology Of Virginia, Pllc
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Virginia BeachUnited StatesUnknown status
Wichita Urology Group
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WichitaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.