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NCT06764485Active, not recruitingPhase 3

A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer

A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
960 (estimated)
First submitted
17 Dec 2024
Start date
13 Mar 2025
Primary completion date
12 Sept 2027
Lead sponsor
Celgene
NCT number
NCT06764485
EU CT number
2024-517422-25-00
EudraCT number
2024-517422-25

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 960
  • From 13 Mar 2025 to the primary completion date, 12 Sept 2027
  • 236 sites in 26 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

  • Participants must not have impaired cardiac function or clinically significant cardiac disease.

Other

  • Participants must not have any brain metastasis.
  • Participants must not have any liver metastasis.
  • Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
  • Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).
  • Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be \< 4.
  • Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).

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

Full criteria on ClinicalTrials.gov

Sites (236)

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

SiteCityCountrySite status
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ABBArgentinaUnknown status
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Buenos AiresArgentinaUnknown status
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CABAArgentinaUnknown status
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Ciudad Autónoma de Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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CórdobaArgentinaUnknown status
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Río CuartoArgentinaUnknown status
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ViedmaArgentinaUnknown status
Universitaetsklinikum Krems
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Krems An Der DonauAustriaActive, not recruiting
Ordensklinikum Linz GmbH
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LinzAustriaActive, not recruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
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SalzburgAustriaActive, not recruiting
Medical University of Vienna
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ViennaAustriaActive, not recruiting
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AdelaideAustraliaUnknown status
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CampbelltownAustraliaUnknown status
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DarlinghurstAustraliaUnknown status
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Elizabeth ValeAustraliaUnknown status
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GreenslopesAustraliaUnknown status
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HeidelbergAustraliaUnknown status
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HobartAustraliaUnknown status
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Kurralta ParkAustraliaUnknown status
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Macquarie UniversityAustraliaUnknown status
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MalvernAustraliaUnknown status
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MelbourneAustraliaUnknown status
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MelbourneAustraliaUnknown status
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MurdochAustraliaUnknown status
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Port MacquarieAustraliaUnknown status
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SouthportAustraliaUnknown status
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WahroongaAustraliaUnknown status
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Belo HorizonteBrazilUnknown status
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NatalBrazilUnknown status
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Porto AlegreBrazilUnknown status
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São PauloBrazilUnknown status
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São PauloBrazilUnknown status
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ChicoutimiCanadaUnknown status
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HalifaxCanadaUnknown status
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KelownaCanadaUnknown status
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MontrealCanadaUnknown status
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MontrealCanadaUnknown status
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QuébecCanadaUnknown status
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RimouskiCanadaUnknown status
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TorontoCanadaUnknown status
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VancouverCanadaUnknown status
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SantiagoChileUnknown status
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SantiagoChileUnknown status
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ValdiviaChileUnknown status
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Viña del MarChileUnknown status
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BeijingChinaUnknown status
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ChangzhouChinaUnknown status
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ChengduChinaUnknown status
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ChengduChinaUnknown status
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ChengduChinaUnknown status
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FuzhouChinaUnknown status
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GuangzhouChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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HefeiChinaUnknown status
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HuizhouChinaUnknown status
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JinanChinaUnknown status
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LinhaiChinaUnknown status
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NanchangChinaUnknown status
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NanjingChinaUnknown status
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NanjingChinaUnknown status
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ShanghaiChinaUnknown status
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ÜrümqiChinaUnknown status
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XiamenChinaUnknown status
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YantaiChinaUnknown status
Masarykuv Onkologicky Ustav
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Brno-StredCzechiaActive, not recruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaActive, not recruiting
University Hospital Olomouc
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OlomoucCzechiaActive, not recruiting
Fakultni Thomayerova nemocnice
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PragueCzechiaActive, not recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaActive, not recruiting
Urocentrum Praha s.r.o.
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PragueCzechiaActive, not recruiting
Fakultni nemocnice v Motole
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PragueCzechiaActive, not recruiting
St. Marien-Krankenhaus GmbH
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Bergisch GladbachGermanyActive, not recruiting
Urologisches Zentrum Mittelhessen - Praxis Biedenkopf
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BiedenkopfGermanyActive, not recruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyActive, not recruiting
Urologicum Duisburg
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DuisburgGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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HerneGermanyActive, not recruiting
Universitaetsklinikum Jena KöR
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JenaGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyActive, not recruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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MunichGermanyActive, not recruiting
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
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NuertingenGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyActive, not recruiting
Aalborg University Hospital
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AalborgDenmarkActive, not recruiting
Aarhus University Hospital
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Aarhus NDenmarkActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Region Hovedstaden
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HerlevDenmarkActive, not recruiting
Hospital Universitario de Badajoz
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BadajozSpainActive, not recruiting
Hospital Universitario de Cruces
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BarakaldoSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitario De Burgos
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BurgosSpainActive, not recruiting
Hospital Universitario Reina Sofia
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CórdobaSpainActive, not recruiting
Hospital Vithas La Salud
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GranadaSpainActive, not recruiting
Hospital Universitario Lucus Augusti
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LugoSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainActive, not recruiting
Complejo Hospitalario Universitario de Ourense
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OurenseSpainActive, not recruiting
Hospital Universitario de Navarra
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PamplonaSpainActive, not recruiting
Parc Tauli Hospital Universitari
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SabadellSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
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KuopioFinlandUnknown status
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OuluFinlandUnknown status
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TampereFinlandUnknown status
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TurkuFinlandUnknown status
Centre Jean Perrin
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Clermont-FerrandFranceActive, not recruiting
Centr Georges Francois Leclerc
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DijonFranceActive, not recruiting
Clinique Victor Hugo
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Le MansFranceActive, not recruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Prive Saint Gregoire
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Saint-GrégoireFranceActive, not recruiting
Institut De Cancerologie Strasbourg Europe
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Strasbourg CedexFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
Oncopole Claudius Regaud
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Toulouse Cedex 9FranceActive, not recruiting
Institut De Cancerologie De Lorraine
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Vandouvre Les NancyFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
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GlasgowUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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NorthwoodUnited KingdomUnknown status
Cork University Hospital
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CorkIrelandActive, not recruiting
Tallaght University Hospital
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Dublin 24IrelandActive, not recruiting
Beaumont Hospital
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Dublin 9IrelandActive, not recruiting
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HaifaIsraelUnknown status
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Kfar SabaIsraelUnknown status
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Petah TikvaIsraelUnknown status
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Ramat GanIsraelUnknown status
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TsrifinIsraelUnknown status
Azienda Unita' Sanitaria Locale Toscana Sud Est
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ArezzoItalyActive, not recruiting
Azienda Ospedaliera per l Emergenza Cannizzaro
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CataniaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti
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FoggiaItalyActive, not recruiting
Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
San Raffaele Hospital
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MilanItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyActive, not recruiting
Istituto Oncologico Veneto
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PadovaItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
Azienda Ospedaliera S Maria Di Terni
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TerniItalyActive, not recruiting
Azienda Provinciale Per I Servizi Sanitari
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TrentoItalyActive, not recruiting
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Goyang-siSouth KoreaUnknown status
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SeongnamSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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Chihuahua CityMexicoUnknown status
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GuadalajaraMexicoUnknown status
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GuadalajaraMexicoUnknown status
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Mexico CityMexicoUnknown status
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MonterreyMexicoUnknown status
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Puebla CityMexicoUnknown status
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandActive, not recruiting
Wojewodzki Szpital Specjalistyczny Nr 4 W Bytomiu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
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BytomPolandActive, not recruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandActive, not recruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandActive, not recruiting
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
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OpolePolandActive, not recruiting
Pratia S.A.
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PoznanPolandActive, not recruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandActive, not recruiting
Polimed Specjalistyczna Przychodnia Lekarska
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WroclawPolandActive, not recruiting
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YaucoPuerto RicoUnknown status
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaActive, not recruiting
CF Clinical Hospital
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Cluj-NapocaRomaniaActive, not recruiting
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaActive, not recruiting
Institutul Regional de Oncologie Iasi
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IașiRomaniaActive, not recruiting
Spitalul Municipal Ploiesti
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PloieştiRomaniaActive, not recruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenActive, not recruiting
Region Skane Skanes Universitetssjukhus
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MalmoSwedenActive, not recruiting
Karolinska University Hospital
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SolnaSwedenActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting
F D Roosevelt University General Hospital Of Banska Bystrica
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Banska BystricaSlovakiaActive, not recruiting
Narodny onkologicky ustav
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BratislavaSlovakiaActive, not recruiting
Urologia s.r.o.
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MartinSlovakiaActive, not recruiting
MILAB s.r.o.
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PrešovSlovakiaActive, not recruiting
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TaichungTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TaoyuanTaiwanUnknown status
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AlbuquerqueUnited StatesUnknown status
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AlbuquerqueUnited StatesUnknown status
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AnaheimUnited StatesUnknown status
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AthensUnited StatesUnknown status
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AuroraUnited StatesUnknown status
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AustinUnited StatesUnknown status
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AustinUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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BirminghamUnited StatesUnknown status
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BuffaloUnited StatesUnknown status
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CharlestonUnited StatesUnknown status
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CharlottesvilleUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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DenverUnited StatesUnknown status
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FrederickUnited StatesUnknown status
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GilbertUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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La JollaUnited StatesUnknown status
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LakelandUnited StatesUnknown status
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LakewoodUnited StatesUnknown status
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Los AlamitosUnited StatesUnknown status
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MilwaukeeUnited StatesUnknown status
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MineolaUnited StatesUnknown status
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MurrayUnited StatesUnknown status
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Myrtle BeachUnited StatesUnknown status
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NashvilleUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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PortlandUnited StatesUnknown status
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PortlandUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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SeattleUnited StatesUnknown status
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SewellUnited StatesUnknown status
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SyracuseUnited StatesUnknown status
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VancouverUnited StatesUnknown status
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Washington D.C.United StatesUnknown status
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WestwoodUnited StatesUnknown status
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WichitaUnited StatesUnknown status
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Willow GroveUnited StatesUnknown status

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