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NCT06919965RecruitingPhase 3

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)

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 (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
220 (estimated)
First submitted
2 Apr 2025
Start date
10 Sept 2025
Primary completion date
6 Apr 2028
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06919965
EU CT number
2024-519493-39-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 220
  • From 10 Sept 2025 to the primary completion date, 6 Apr 2028
  • 121 sites in 15 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.

Other illness

  • Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is \[i.e.\], T2, T3, T4, N+, and/or M+)
  • Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer (\[N0, M0\] with a Gleason score less than or equal to \[\<=\] 7a, treated locally only \[radical prostatectomy/radiation therapy/focal treatment\]) and other malignancy that is considered at minimal risk of recurrence
  • A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters (mL)

Other

  • Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210
  • Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Who the study is looking for

  • Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded
  • 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
  • All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC
  • Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade \>= 2 toxicity requiring BCG discontinuation (BCG intolerant population)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
  • Must be ineligible for or refusing radical cystectomy (RC)

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

Full criteria on ClinicalTrials.gov

Sites (121)

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

SiteCityCountrySite status
Investigaciones Clinico Moleculares (ICM)
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ChabasArgentinaRecruiting
Instituto Alexander Fleming
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Ciudad EvitaArgentinaRecruiting
Centro Urológico Profesor Bengió
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CórdobaArgentinaRecruiting
Sanatorio de la Mujer
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RosarioArgentinaRecruiting
Hospital Sirio Libanes
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San Martín de los AndesArgentinaRecruiting
Hopital Erasme
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AnderlechtBelgiumRecruiting
AZ ST-JAN Brugge A.V.
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BruggeBelgiumRecruiting
Ziekenhuis Oost-Limburg
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GenkBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Az Maria Middelares Gent
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumRecruiting
Liga Norte Riograndense Contra o Cancer
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NatalBrazilRecruiting
Hospital Regional do Cancer Hospital de Esperanca
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Presidente PrudenteBrazilRecruiting
Funfarme Sjrp
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São José do Rio PretoBrazilRecruiting
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
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São PauloBrazilRecruiting
Real e Benemerita Associacao Portuguesa de Beneficencia
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São PauloBrazilRecruiting
Peking University First Hospital
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BeijingChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
The Third People's Hospital of Chengdu
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ChengduChinaRecruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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GuangzhouChinaRecruiting
Nanjing Drum Tower hospital
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NanjingChinaRecruiting
The First Affiliated Hospital of Ningbo University
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NingboChinaCompleted
The Second Hospital of Tianjin Medical University
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TianjinChinaRecruiting
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
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WuhanChinaRecruiting
Yantai Yuhuangding Hospital
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YantaiChinaRecruiting
University Hospital Cologne AöR
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CologneGermanyRecruiting
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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HerneGermanyRecruiting
Klinikum Leverkusen gGmbH
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LeverkusenGermanyRecruiting
Heidelberg University
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MannheimGermanyRecruiting
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
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NuertingenGermanyRecruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyRecruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
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BarcelonaSpainRecruiting
Hospital Universitario Puerta del Mar
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CadizSpainRecruiting
Hospital General Universitario De Castellon
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Castello De La PlanaSpainRecruiting
Area Sanitaria De Ferrol
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FerrolSpainRecruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Parc Tauli Hospital Universitari
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SabadellSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Hopitaux Universitaires Pitie Salpetriere
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ParisFranceRecruiting
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
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ParisFranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceRecruiting
Capio La Croix Du Sud
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Quint-FonsegrivesFranceRecruiting
Centre Hospitalier Prive Saint Gregoire
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Saint-GrégoireFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Hull University Teaching Hospitals NHS Trust
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CottinghamUnited KingdomRecruiting
St Bartholomews Hospital
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LondonUnited KingdomRecruiting
Royal Marsden Hospital
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SkerrayUnited KingdomRecruiting
Southampton University Hospital
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SouthamptonUnited KingdomRecruiting
Lister Hospital
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StevenageUnited KingdomRecruiting
General Hospital of Athens "G. Gennimatas"
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AthensGreeceRecruiting
Laiko General Hospital of Athens
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AthensGreeceRecruiting
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceRecruiting
Sismanogleio General Hospital
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MaroussiGreeceRecruiting
General University Hospital Of Patras
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PatrasGreeceRecruiting
Athens Medical Center S.A.
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ThessalonikiGreeceRecruiting
Carmel Medical Center
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HaifaIsraelRecruiting
Rambam Medical Center
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HaifaIsraelRecruiting
Meir Medical Center
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Kfar SabaIsraelRecruiting
Rabin Medical Center
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Petah TikvaIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelRecruiting
Cliniche Gavazzeni S.p.A.
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BergamoItalyRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
Azienda Sociosanitaria 3
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GenoaItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyRecruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyRecruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyRecruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyRecruiting
Juntendo University Hospital
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Bunkyō CityJapanRecruiting
Funabashi Municipal Medical Center
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FunabashiJapanRecruiting
Hakodate Goryoukaku Hospital
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HakodateJapanRecruiting
St. Marianna University Hospital
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KawasakiJapanRecruiting
The Jikei University Hospital
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MinatokuJapanRecruiting
Toho University Sakura Medical Center
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SakuraJapanRecruiting
Yokohama City University Medical Center
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YokohamaJapanRecruiting
Yokohama Municipal Citizen's Hospital
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YokohamaJapanRecruiting
Chungbuk National University Hospital
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Cheongju-siSouth KoreaRecruiting
Samsung Medical Center
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GangguSouth KoreaRecruiting
Seoul National University Bundang Hospital
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SeongnamSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Canisius Wilhelmina Ziekenhuis
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NijmegenNetherlandsRecruiting
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
Georgia Urology
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AtlantaUnited StatesRecruiting
Urology Austin
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AustinUnited StatesRecruiting
Texas Oncology - Austin
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AustinUnited StatesRecruiting
MidLantic Urology
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Bala-CynwydUnited StatesRecruiting
Urology of Indiana
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CarmelUnited StatesRecruiting
Dayton Physicians Network Urology
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CentervilleUnited StatesRecruiting
Associated Urological Specialists
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Chicago RidgeUnited StatesRecruiting
The Urology Group
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CincinnatiUnited StatesCompleted
Central Ohio Urology Group
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GahannaUnited StatesRecruiting
The Conrad Pearson Clinic
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GermantownUnited StatesRecruiting
UroPartners
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GlenviewUnited StatesRecruiting
Southern Urology LLC
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LafayetteUnited StatesRecruiting
Colorado Clinical Research
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LakewoodUnited StatesRecruiting
Keystone Urology Specialists
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LancasterUnited StatesRecruiting
Advanced Urology Institute
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LargoUnited StatesRecruiting
UCLA
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Los AngelesUnited StatesRecruiting
Helios Clinical Research, LLC
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Middleburg HeightsUnited StatesCompleted
Carolina Urologic Research Center
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Myrtle BeachUnited StatesRecruiting
UroHealth Partners
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OmahaUnited StatesCompleted
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
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PittsburghUnited StatesRecruiting
Greater Boston Urology
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PlymouthUnited StatesRecruiting
Comprehensive Urology
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Royal OakUnited StatesRecruiting
Urology San Antonio, PA dba USA Clinical Trials
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San AntonioUnited StatesRecruiting
Oregon Urology Institute
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SpringfieldUnited StatesRecruiting
Academic Urology and Urogynecology of Arizona
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Sun CityUnited StatesRecruiting
Associated Medical Professionals
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SyracuseUnited StatesRecruiting
New Jersey Urology LLC
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Voorhees TownshipUnited StatesRecruiting

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