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NCT07164443RecruitingPhase 3

A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Engaging Agent Targeting Human Kallikrein 2, With or Without JNJ-87189401, a PSMA-CD28 Costimulatory Agent, Plus Best Supportive Care Versus Best Supportive Care for Late-line Metastatic Castration-resistant Prostate Cancer

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1203 (estimated)
First submitted
4 Sept 2025
Start date
2 Sept 2025
Primary completion date
18 Aug 2028
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT07164443
EU CT number
2025-520927-26-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1203
  • From 2 Sept 2025 to the primary completion date, 18 Aug 2028
  • 177 sites in 17 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

  • Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤ 2) deep vein thrombosis is not exclusionary
  • Participants with Grade 1 or higher fever (≥38ºC) or active infection requiring systemic treatment within 7 days prior to randomization are ineligible. Participants must be afebrile (\<38ºC) at the time of study treatment dosing unless approved by medical monitor
  • Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Any of the following within 6 months prior to first dose of study treatment:
  • Myocardial infarction B) Severe or unstable angina C) Clinically significant ventricular arrhythmias D) Congestive heart failure (New York Heart Association class II to IV) E) Transient ischemic attack F) Cerebrovascular accident
    • \- Prior treatment with any CD3-directed therapy

Other illness

  • Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus)

Other

  • Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (\>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenation

Who the study is looking for

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (chest, abdomen, and pelvis) and 99m\^Tc bone scan. Visceral disease is not allowed
  • PSA greater than or equal to (≥) 2 nanogram per milliliter (ng/mL) at screening
  • In the opinion of the investigator, the next best treatment option is a clinical trial
  • Participants are required to have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following:
    • Androgen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI
    • Taxanes: Required to have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if:
  • Cabazitaxel is not available
  • The participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period
    • Radioligand therapy: Required to have been previously treated with at least 1 dose of Prostate-specific membrane antigen (PSMA)-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies:
  • PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.
  • The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy.
    • Polyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Required to have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available
  • Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog \[agonist or antagonist\]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Participants are eligible if they have the following values:
  • eGFR ≥ 40 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (≤) 3 times the Upper Limit of Normal (ULN) C) Total bilirubin \<1.5 times ULN D) Absolute neutrophil count (ANC) ≥ 1.0x10\^9/per liter (L) E) Hemoglobin ≥ 8.0 grams per deciliter (g/dL) F) Platelet count ≥ 75x10\^9/L

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

Full criteria on ClinicalTrials.gov

Sites (177)

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

SiteCityCountrySite status
Warringal Private Hospital
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HeidelbergAustraliaRecruiting
ICON Cancer Care
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Kurralta ParkAustraliaRecruiting
Peter MacCallum Cancer Centre
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MelbourneAustraliaRecruiting
Fiona Stanley Hospital
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MurdochAustraliaRecruiting
Princess Alexandra Hospital
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WoolloongabbaAustraliaRecruiting
Ziekenhuis Aan De Stroom
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AntwerpBelgiumRecruiting
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumRecruiting
Az Maria Middelares Gent
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GentBelgiumRecruiting
Universiteit Gent
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GentBelgiumRecruiting
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumRecruiting
Chu Helora
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La LouvièreBelgiumRecruiting
CHC MontLégia
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LiègeBelgiumRecruiting
Clinique Saint Pierre
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Ottignies-Louvain-la-NeuveBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
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FlorianópolisBrazilRecruiting
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
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JoinvilleBrazilRecruiting
Liga Norte Riograndense Contra o Cancer
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NatalBrazilRecruiting
Hospital Moinhos de Vento
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Porto AlegreBrazilRecruiting
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilRecruiting
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaRecruiting
Lakeridge Health
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OshawaCanadaRecruiting
CHU de Quebec-Universite Laval
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QuébecCanadaRecruiting
Sunnybrook Health Sciences Center
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TorontoCanadaRecruiting
Princess Margaret Hospital
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TorontoCanadaRecruiting
BC Cancer - Vancouver
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VancouverCanadaRecruiting
Peking University First Hospital
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BeijingChinaRecruiting
The First Bethune Hospital of Jilin University
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ChangchunChinaRecruiting
West China Hospital of Sichuan University
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ChengduChinaRecruiting
The Third People's Hospital of Chengdu
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ChengduChinaRecruiting
Chongqing University Cancer Hospital
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ChongqingChinaRecruiting
Sun Yat-sen University Cancer Center
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GuangzhouChinaRecruiting
Nanjing Drum Tower hospital
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NanjingChinaRecruiting
The First Affiliated Hospital of Guangxi Medical University
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NanningChinaRecruiting
Nantong Tumor Hospital
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NantongChinaRecruiting
The First Affiliated Hospital of Ningbo University
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NingboChinaRecruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
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
Zhongnan Hospital Wu Han University
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WuhanChinaRecruiting
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaRecruiting
Staedtisches Klinikum Braunschweig gGmbH
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BrunswickGermanyRecruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyRecruiting
Urologicum Duisburg
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DuisburgGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Krankenhaus Nordwest GmbH
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Frankfurt am MainGermanyRecruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyRecruiting
National Center for Tumor Diseases (NCT) Heidelberg
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HeidelbergGermanyRecruiting
Universitaet Muenster
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MuensterGermanyRecruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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MunichGermanyRecruiting
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
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NuertingenGermanyRecruiting
Klinikum Nuernberg
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NurembergGermanyRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceRecruiting
Centr Georges Francois Leclerc
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DijonFranceRecruiting
Centre Oscar Lambret
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LilleFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Fondation Hôpital Saint-Joseph
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ParisFranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Institut De Cancerologie De L Ouest
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Saint-Herblain CedexFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceRecruiting
Oncopole Claudius Regaud
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ToulouseFranceRecruiting
Institut de cancérologie de Lorraine
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Vandoeuvre Les Nancy_ CedexFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
University Hospitals Birmingham NHS Foundation Trust
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BirminghamUnited KingdomRecruiting
University College London Hospitals
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LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust - Christie Hospital
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ManchesterUnited KingdomRecruiting
Royal Marsden Hospital (Sutton)
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SuttonUnited KingdomRecruiting
Istituto Oncologico Veneto
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Castelfranco VenetoItalyRecruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti
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FoggiaItalyRecruiting
Istituto Nazionale dei Tumori
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyRecruiting
ARNAS Civico Di Cristina Benfratelli
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PalermoItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyRecruiting
Institute of Science Tokyo Hospital
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Bunkyō CityJapanRecruiting
Kyushu University Hospital
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FukuokaJapanRecruiting
Gifu University Hospital
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GifuJapanRecruiting
Saitama Medical University International Medical Center
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HidakaJapanRecruiting
Kanazawa University Hospital
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KanazawaJapanRecruiting
National Cancer Center Hospital East
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KashiwaJapanRecruiting
Kobe University Hospital
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KobeJapanRecruiting
National Hospital Organization Shikoku Cancer Center
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MatsuyamaJapanRecruiting
National Hospital Organization Tokyo Medical Center
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Meguro-KuJapanRecruiting
Toho University Sakura Medical Center
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SakuraJapanRecruiting
Hokkaido University Hospital
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SapporoJapanRecruiting
Yokohama City University Hospital
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YokohamaJapanRecruiting
Yokohama City University Medical Center
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YokohamaJapanRecruiting
Yokosuka Kyosai Hospital
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YokosukaJapanRecruiting
Chungnam National University Hospital
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DaejeonSouth KoreaRecruiting
National Cancer Center
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Goyang-siSouth KoreaRecruiting
Chonnam National University Hwasun Hospital
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HwasunGunSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Reinier de Graaf Groep
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DelftNetherlandsRecruiting
Stichting Martini Ziekenhuis
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GroningenNetherlandsRecruiting
Tergooiziekenhuizen
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HilversumNetherlandsRecruiting
Spaarne Gasthuis Stichting
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HoofddorpNetherlandsRecruiting
Academisch Ziekenhuis Maastricht
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MaastrichtNetherlandsRecruiting
Canisius Wilhelmina Ziekenhuis
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NijmegenNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Isala Klinieken Stichting
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ZwolleNetherlandsRecruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandRecruiting
In- Vivo Sp. z o. o.
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BydgoszczPolandRecruiting
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
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KoszalinPolandRecruiting
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
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WarsawPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Pan American Center for Oncology Trials LLC
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Rio PiedrasPuerto RicoRecruiting
Puerto Rico Medical Research Center
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San JuanPuerto RicoRecruiting
Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
Tungs' Taichung MetroHarbor Hospital
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TaichungTaiwanRecruiting
Taichung Veterans General Hospital
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TaichungTaiwanRecruiting
Taipei Veterans General Hospital
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TaipeiTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanRecruiting
University of Michigan Health System
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Ann ArborUnited StatesRecruiting
Rocky Mountain Cancer Centers
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AuroraUnited StatesRecruiting
University of Colorado Cancer Center
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AuroraUnited StatesRecruiting
MidLantic Urology
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Bala-CynwydUnited StatesRecruiting
Johns Hopkins University
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BaltimoreUnited StatesRecruiting
Bay Pines VA Healthcare System
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Bay PinesUnited StatesRecruiting
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
NYU Langone Hospitals
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BrooklynUnited StatesRecruiting
Ralph H Johnson Veterans Hospital
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CharlestonUnited StatesRecruiting
Levine Cancer Institute
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CharlotteUnited StatesRecruiting
Tennessee Oncology - Chattanooga
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ChattanoogaUnited StatesRecruiting
University of Cincinnati
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CincinnatiUnited StatesRecruiting
University Hospital of Cleveland
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ClevelandUnited StatesRecruiting
Urology Clinics of North Texas
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DallasUnited StatesCompleted
UT Southwestern Medical Center
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DallasUnited StatesRecruiting
Henry Ford Cancer- Detroit
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DetroitUnited StatesRecruiting
Virginia Cancer Specialists
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FairfaxUnited StatesRecruiting
Florida Cancer Specialists & Research Institute
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Fort MyersUnited StatesRecruiting
Gibbs Cancer Center and Research Institute Pelham
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GreerUnited StatesRecruiting
Hartford Hospital
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HartfordUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
Michael E. DeBakey VA Medical Center
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HoustonUnited StatesRecruiting
University of Iowa Hospital and Clinics
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Iowa CityUnited StatesRecruiting
University of California at San Diego
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La JollaUnited StatesRecruiting
Colorado Clinical Research
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LakewoodUnited StatesRecruiting
Keystone Urology Specialists
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LancasterUnited StatesRecruiting
Ronald Reagan UCLA Medical Center
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Los AngelesUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
East Jefferson General Hospital
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MetairieUnited StatesRecruiting
NYU Langone Hospital - Long Island
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MineolaUnited StatesRecruiting
University of Minnesota Medical Center
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MinneapolisUnited StatesRecruiting
Carolina Urologic Research Center
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Myrtle BeachUnited StatesRecruiting
Tennessee Oncology - Nashville
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NashvilleUnited StatesRecruiting
Columbia University Medical Center
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New YorkUnited StatesRecruiting
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
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New YorkUnited StatesRecruiting
Virginia Oncology Associates
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NorfolkUnited StatesRecruiting
XCancer Omaha / Urology Cancer Center
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OmahaUnited StatesCompleted
Penn Medicine Abramson Cancer Center
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PhiladelphiaUnited StatesRecruiting
UPMC Cancer Centers
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PittsburghUnited StatesRecruiting
Compass Oncology
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PortlandUnited StatesCompleted
VA Portland Health Care System
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PortlandUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesRecruiting
Blue Ridge Cancer Care
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RoanokeUnited StatesRecruiting
Utah Cancer Specialists
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Salt Lake CityUnited StatesRecruiting
San Francisco VA Medical Center
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San FranciscoUnited StatesRecruiting
University of Washington
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SeattleUnited StatesRecruiting
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesRecruiting
VA Puget Sound Healthcare System
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SeattleUnited StatesRecruiting
Gibbs Cancer Center
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SpartanburgUnited StatesRecruiting
Oregon Urology Institute
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SpringfieldUnited StatesRecruiting
Moffitt Cancer Center
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TampaUnited StatesRecruiting
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
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Washington D.C.United StatesRecruiting
Mission Cancer Blood
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WaukeeUnited StatesRecruiting
Texas Oncology - West Texas
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Wichita FallsUnited StatesRecruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
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Winston-SalemUnited StatesRecruiting

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