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NCT06319820RecruitingPhase 3

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
641 (estimated)
First submitted
13 Mar 2024
Start date
18 Apr 2024
Primary completion date
28 Jun 2028
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06319820

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 641
  • From 18 Apr 2024 to the primary completion date, 28 Jun 2028
  • 193 sites in 20 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

  • Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy
  • Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)
    • Substudy:
    • \- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis

Other illness

  • Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs

Other

  • Polyuria with recorded 24-hour urine volumes \> 4000 milliliters (mL)
  • Current indwelling urinary catheters, however, intermittent catheterization is acceptable

Who the study is looking for

  • Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (\>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor \>= 3 cm, iii. Early recurrence (less than \[\<\] 1 year), iv. Frequent recurrence (greater than \[\>\] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)
  • Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and \>=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor \>=3 cm
  • Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing
  • Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.
  • Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy
  • Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
  • Have an Eastern Cooperative Oncology Group performance status of 0 to 2

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

Full criteria on ClinicalTrials.gov

Sites (193)

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

SiteCityCountrySite status
Hospital Sirio Libanes
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Buenos AiresArgentinaActive, not recruiting
Investigaciones Clinico Moleculares (ICM)
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ChabasArgentinaActive, not recruiting
Centro Urológico Profesor Bengió
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CórdobaArgentinaActive, not recruiting
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
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CórdobaArgentinaActive, not recruiting
Hospital Privado de la Comunidad
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Mar del PlataArgentinaActive, not recruiting
Sanatorio de la Mujer
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RosarioArgentinaActive, not recruiting
Medizinische Universitaet Graz
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GrazAustriaRecruiting
Medizinische Universität Innsbruck
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InnsbruckAustriaRecruiting
Medical University Vienna MUV
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Leopoldsdorf (Wien)AustriaRecruiting
Ordensklinikum Linz GmbH Elisabethinen
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LinzAustriaRecruiting
Universitaetsklinikum Salzburg Landeskrankenhaus
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SalzburgAustriaRecruiting
AZORG Campus Aalst-Moorselbaan
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AalstBelgiumRecruiting
AZ Sint-Jan
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Brugge (Bruges)BelgiumRecruiting
UZ Antwerpen
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EdegemBelgiumCompleted
AZ Maria Middelares
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Gent (Ghent)BelgiumRecruiting
Universitair Ziekenhuis Gasthuisberg
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LeuvenBelgiumActive, not recruiting
Vitaz
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Sint-NiklaasBelgiumRecruiting
CHU UCL Namur - Site Godinne
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YvoirBelgiumRecruiting
Fundacao Pio XII
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BarretosBrazilActive, not recruiting
Universidade Estadual De Campinas
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CampinasBrazilCompleted
Liga Norte Riograndense Contra o Cancer
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NatalBrazilActive, not recruiting
Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilActive, not recruiting
Hospital Moinhos de Vento
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Porto AlegreBrazilActive, not recruiting
HBA SA Assitencia Medica e Hospitalar
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SalvadorBrazilActive, not recruiting
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
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Santo AndréBrazilActive, not recruiting
Real e Benemerita Associacao Portuguesa de Beneficencia
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São PauloBrazilActive, not recruiting
Irmandade Santa Casa de Misericordia de Sao Paulo
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São PauloBrazilActive, not recruiting
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilCompleted
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
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São PauloBrazilActive, not recruiting
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaActive, not recruiting
Peking University Third Hospital
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BeijingChinaActive, not recruiting
Hunan Cancer Hospital
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ChangshaChinaActive, not recruiting
The Third People's Hospital of Chengdu
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ChengduChinaActive, not recruiting
West China School of Medicine/West China Hospital, Sichuan University
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ChengduChinaActive, not recruiting
Chongqing Cancer Hospital
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ChongqingChinaActive, not recruiting
Fujian Medical University Union Hospital
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FuzhouChinaActive, not recruiting
Sun Yat-sen University Cancer Center
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GuangzhouChinaActive, not recruiting
Zhongda Hospital Southeast University
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NanjingChinaActive, not recruiting
Nanjing Drum Tower hospital
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NanjingChinaActive, not recruiting
Huadong Hospital Affiliated to Fudan University
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ShanghaiChinaActive, not recruiting
The Second Hospital of Tianjin Medical University
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TianjinChinaActive, not recruiting
Cancer Hospital of Xinjiang Medical University
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ÜrümqiChinaActive, not recruiting
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaActive, not recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
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WuhanChinaActive, not recruiting
The First Affiliated Hospital of Xian Jiaotong University
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XinshiChinaActive, not recruiting
The affiliated hospital of xuzhou medical university
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XuzhouChinaActive, not recruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaCompleted
Fakultni nemocnice Olomouc
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OlomoucCzechiaRecruiting
Fakultni Thomayerova nemocnice
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PragueCzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
Fakultni nemocnice v Motole
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PragueCzechiaRecruiting
Charite - Universitaetsmedizin Berlin (CCM)
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BerlinGermanyActive, not recruiting
Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
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BraunschweigGermanyRecruiting
Studienzentrum Bayenthal
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CologneGermanyRecruiting
Urologische Gemeinschaftspraxis
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DresdenGermanyCompleted
Universitaetsklinikum Frankfurt
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Frankfurt am MainGermanyRecruiting
Urologikum Hamburg MVZ - Germany
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HamburgGermanyActive, not recruiting
Marien Hospital Herne
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HerneGermanyRecruiting
Universitätsklinikum Jena
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JenaGermanyActive, not recruiting
Klinikum rechts der Isar an der Technischen Universitat Munchen
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MünchenGermanyCompleted
Klinikum St. Elisabeth Straubing GmbH
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StraubingGermanyRecruiting
Katharinenhospital Innere Medizin
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StuttgartGermanyCompleted
Aarhus University Hospital
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AarhusDenmarkRecruiting
Rigshospitalet
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CopenhagenDenmarkRecruiting
Herlev Hospital
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HerlevDenmarkRecruiting
Odense Universitetshospital
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OdenseDenmarkRecruiting
Zealand University Hospital
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RoskildeDenmarkRecruiting
Hosp. Univ. de La Ribera
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AlziraSpainRecruiting
Hosp Univ Vall D Hebron
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BarcelonaSpainCompleted
Hosp Clinic de Barcelona
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BarcelonaSpainRecruiting
Fund. Puigvert
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BarcelonaSpainRecruiting
Hosp. Puerta Del Mar
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CadizSpainRecruiting
Hosp. Gral. Univ. de Castellon
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CastillónSpainRecruiting
Hosp. de Jerez de La Frontera
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Jerez de la FronteraSpainRecruiting
Hosp Univ A Coruna
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La Coruña (A Coruña)SpainRecruiting
Hosp. Univ. 12 de Octubre
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MadridSpainRecruiting
Hosp. Gral. Univ. Gregorio Maranon
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MadridSpainCompleted
Clinica Univ. de Navarra
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MadridSpainRecruiting
Hosp Virgen de La Victoria
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MálagaSpainRecruiting
Hosp. Univ. Central de Asturias
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OviedoSpainCompleted
Hosp.Univ.Parc Tauli
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SabadellSpainRecruiting
Hosp. Virgen Del Rocio
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SevilleSpainCompleted
Hosp. Clinico Univ. de Valencia
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ValenciaSpainRecruiting
Hospital Center University De Lille
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LilleFranceCompleted
Polyclinique de Limoges - Francois Chenieux
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LimogesFranceRecruiting
Hopital Edouard Herriot
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LyonFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
CHU Pitie Salpetriere
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ParisFranceRecruiting
Hopital Saint Louis
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ParisFranceRecruiting
APHP-Hôpital Bichat - Claude Bernard
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ParisFranceRecruiting
Clinique de la Croix du Sud
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Quint-FonsegrivesFranceRecruiting
CHU Rennes - Hopital Pontchaillou
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RennesFranceCompleted
CHU Rangueil
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ToulouseFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Southmead Hospital
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BristolUnited KingdomActive, not recruiting
St Bartholomews Hospital
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LondonUnited KingdomActive, not recruiting
Charing Cross Hospital
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LondonUnited KingdomActive, not recruiting
Newcastle Freeman Hospital
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Newcastle upon TyneUnited KingdomActive, not recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
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SheffieldUnited KingdomActive, not recruiting
Southampton General Hospital
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SouthamptonUnited KingdomActive, not recruiting
Royal Marsden Hospital
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SuttonUnited KingdomActive, not recruiting
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaActive, not recruiting
Prince of Wales Hospital
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Hong KongHong Kong SAR ChinaActive, not recruiting
Cork University Hospital
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CorkIrelandActive, not recruiting
Mater Private Hospital
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DublinIrelandActive, not recruiting
Mater Misericordiae University Hospital
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DublinIrelandActive, not recruiting
Adelaide and Meath Hospital
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DublinIrelandActive, not recruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Ziv Medical Center
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SderotIsraelRecruiting
Sourasky Medical Center
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Tel AvivIsraelRecruiting
Hadassah University Hospita Ein Kerem
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YeruhamIsraelCompleted
Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica
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ArezzoItalyRecruiting
Cliniche Humanitas Gavazzeni
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BergamoItalyRecruiting
ASST Spedali Civili Brescia
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BresciaItalyRecruiting
Istituto Dei Tumori Di Milano
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MilanItalyRecruiting
Ospedale San Raffaele
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MilanItalyCompleted
Universita Campus Bio-Medico di Roma
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RomagnanoItalyRecruiting
Istituto Nazionale Tumori Regina Elena
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RomagnanoItalyRecruiting
Istituto Clinico Humanitas
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RozzanoItalyRecruiting
A.O.Citta della Salute e della Scienza di Torino
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TorinoItalyRecruiting
Hyogo Prefectural Amagasaki General Medical Center
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AmagasakiJapanActive, not recruiting
St. Marianna University Hospital
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KawasakiJapanRecruiting
Kobe City Medical Center General Hospital
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KobeJapanActive, not recruiting
National Hospital Organization Kumamoto Medical Center
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KumamotoJapanActive, not recruiting
Osaka International Cancer Institute
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OsakaJapanRecruiting
Gunma Prefectural Cancer Center
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Ōta-kuJapanRecruiting
Saitama Medical Center
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SaitamaJapanActive, not recruiting
JRC Wakayama Medical Center
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WakayamaJapanActive, not recruiting
Yokohama Municipal Citizen's Hospital
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YokohamaJapanRecruiting
Yokohama City University Medical Center
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YokohamaJapanActive, not recruiting
Yokosuka Kyosai Hospital
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YokosukaJapanRecruiting
Chungbuk National University Hospital
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ChuncheonSouth KoreaCompleted
National Cancer Center
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GyeonginSouth KoreaRecruiting
Chonnam National University Hwasun Hospital
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Sangam-dongSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaActive, 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
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
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BydgoszczPolandCompleted
Uniwersytecki Szpital Kliniczny nr 4
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LublinPolandActive, not recruiting
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
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PrzemyślPolandActive, not recruiting
Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
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TarnówPolandActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandCompleted
Mazowiecki Szpital Onkologiczny Sp z o o
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WielePolandActive, not recruiting
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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WroclawPolandCompleted
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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WroclawPolandActive, not recruiting
University of Colorado Cancer Center Anschultz Cancer Pavilion
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AuroraUnited StatesCompleted
Urology Austin
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AustinUnited StatesActive, not recruiting
MidLantic Urology
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Bala-CynwydUnited StatesCompleted
Brigham and Women's Hospital
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BostonUnited StatesCompleted
Levine Cancer Institute
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CharlotteUnited StatesActive, not recruiting
Northwestern University
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ChicagoUnited StatesCompleted
UT Southwestern
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DallasUnited StatesCompleted
Urology Clinics of North Texas
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DallasUnited StatesActive, not recruiting
Karmanos Cancer Institute
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DetroitUnited StatesActive, not recruiting
The Conrad Pearson Clinic
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GermantownUnited StatesActive, not recruiting
Chesapeake Urology Research Associates
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HanoverUnited StatesCompleted
Houston Metro Urology
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HoustonUnited StatesActive, not recruiting
First Urology
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JeffersonvilleUnited StatesCompleted
University of Tennessee Medical Center
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KnoxvilleUnited StatesCompleted
Colorado Clinical Research
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LakewoodUnited StatesActive, not recruiting
Keystone Urology Specialists
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LancasterUnited StatesActive, not recruiting
Arkansas Urology
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Little RockUnited StatesCompleted
Genesis Research , LLC
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Los AlamitosUnited StatesActive, not recruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesActive, not recruiting
Carolina Urologic Research Center
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Myrtle BeachUnited StatesActive, not recruiting
Urology Associates
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NashvilleUnited StatesActive, not recruiting
Cancer Institute of New Jersey
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New BrunswickUnited StatesActive, not recruiting
Ochsner Health System
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New OrleansUnited StatesActive, not recruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesActive, not recruiting
Integrated Medical Professionals
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New YorkUnited StatesCompleted
The Urology Center, PC
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OmahaUnited StatesActive, not recruiting
University of California Irvine Medical Center
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OrangeUnited StatesActive, not recruiting
Associated Urologists of North Carolina
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RaleighUnited StatesActive, not recruiting
Comprehensive Urology
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Royal OakUnited StatesActive, not recruiting
Om Research LLC
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San DiegoUnited StatesActive, not recruiting
Specialty Clinical Research of St Louis
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San LuisUnited StatesActive, not recruiting
Mercy Research
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San LuisUnited StatesCompleted
Genesis Research LLC 1
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Sherman OaksUnited StatesCompleted
Spokane Urology
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SpokaneUnited StatesActive, not recruiting
Associated Medical Professionals of NY
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SyracuseUnited StatesActive, not recruiting
SUNY Upstate Med Univ
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SyracuseUnited StatesActive, not recruiting
Moffitt Cancer Center
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TampaUnited StatesActive, not recruiting
Wichita Urology Group
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WichitaUnited StatesActive, not recruiting
Adana Baskent Practice and Research Hospital
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AdanaTurkey (Türkiye)Completed
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
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AnkaraTurkey (Türkiye)Recruiting
Ankara University Medical Faculty
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AnkaraTurkey (Türkiye)Completed
T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
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IstanbulTurkey (Türkiye)Recruiting
Istanbul University Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Completed
Kartal Dr Lutfi Kirdar Sehir Hastanesi
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IstanbulTurkey (Türkiye)Recruiting
Dokuz Eylul University Medical Faculty
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?zmirTurkey (Türkiye)Recruiting

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