New T-Cell therapy aims to fight Hard-to-Treat prostate cancer
NCT ID NCT07164443
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 7 times
Summary
This phase 3 study tests a drug called pasritamig, which helps the body's immune T-cells attack prostate cancer cells. The trial includes 663 men with metastatic castration-resistant prostate cancer, a stage where standard hormone therapy no longer works. Participants receive either pasritamig plus best supportive care or a placebo plus best supportive care, and researchers will compare how long they live.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pasritamig (a T-cell redirecting agent)
- What this could lead to
- If successful, this could provide a new treatment option that extends survival for men with advanced prostate cancer that has stopped responding to hormone therapy.
- What could go wrong
- This is a large phase 3 trial, but the drug is still experimental. It may not improve survival compared to placebo, and side effects from T-cell activation can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,203 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * 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: 1. Cabazitaxel is not available 2. 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: 1. PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated. 2. 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: A) 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 Exclusion Criteria * Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤ 2) deep vein thrombosis is not exclusionary * Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus) * 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 * Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (\>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenation * 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: A) 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
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic castration resistant prostate cancer are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
171 sites in 17 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
RECRUITINGTorino, 10126, Italy
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AZ Maria Middelares
RECRUITINGGhent, 9000, Belgium
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AZ Sint-Jan
RECRUITINGBruges, 8000, Belgium
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Arthur J E Child Comprehensive Cancer Centre
RECRUITINGCalgary, Alberta, T2N 5G2, Canada
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Atrium Health Wake Forest Baptist Comprehensive Cancer Center
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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Az Groeninge
RECRUITINGKortrijk, 8500, Belgium
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Azienda Di Rilievo Nazionale E Di Alta Specializzazione
RECRUITINGPalermo, 90127, Italy
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Azienda Ospedaliera Universitaria Federico II
RECRUITINGNaples, 80131, Italy
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BC Cancer Vancouver
RECRUITINGVancouver, British Columbia, V5Z 4E6, Canada
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Bay Pines VA Healthcare System
RECRUITINGBay Pines, Florida, 33744, United States
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Blue Ridge Cancer Care
RECRUITINGRoanoke, Virginia, 24014, United States
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CHC MontLegia
RECRUITINGLiège, 4000, Belgium
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CHRU Brest - Hopital Morvan
RECRUITINGBrest, 29200, France
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CHU Lyon Sud
RECRUITINGPierre-Bénite, 69495, France
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CHU de Quebec Universite Laval
RECRUITINGQuébec, Quebec, G1J 1Z4, Canada
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Canisius-Wilhelmina ZH
RECRUITINGNijmegen, 6532 SZ, Netherlands
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Carolina Urologic Research Center
RECRUITINGMyrtle Beach, South Carolina, 29572, United States
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Cedars Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Centre Georges Francois Leclerc
RECRUITINGDijon, 21000, France
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Centre Leon Berard
RECRUITINGLyon, 69008, France
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Centre Oscar Lambret
RECRUITINGLille, 59000, France
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Chang Gung Memorial Hospital
RECRUITINGKaohsiung City, 833, Taiwan
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Chongqing University Cancer Hospital
RECRUITINGChongqing, 400030, China
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Chonnam National University Hwasun Hospital
RECRUITINGHwasungun, 58128, South Korea
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Chu Helora Hospital La Louviere Site Jolimont
RECRUITINGLa Louvière, 7100, Belgium
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Chungnam National University Hospital
RECRUITINGDaejeon, 35015, South Korea
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Clinique Saint Pierre
RECRUITINGOttignies, 1340, Belgium
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Cliniques Universitaires Saint Luc
RECRUITINGBrussels, 1200, Belgium
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Colorado Clinical Research
RECRUITINGLakewood, Colorado, 80228, United States
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Columbia University Medical Center
RECRUITINGNew York, New York, 10032, United States
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Compass Oncology
COMPLETEDPortland, Oregon, 97227, United States
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02115, United States
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East Jefferson General Hospital
RECRUITINGMetairie, Louisiana, 70006, United States
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Erasmus MC
RECRUITINGRotterdam, 3015 GD, Netherlands
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Fiona Stanley Hospital
RECRUITINGMurdoch, 6150, Australia
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Florida Cancer Specialists & Research Institute
RECRUITINGFort Myers, Florida, 33901, United States
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Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITINGMilan, 20133, Italy
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Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITINGRoma, 00168, Italy
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Fred Hutchinson Cancer Research Center
RECRUITINGSeattle, Washington, 98109, United States
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, 200032, China
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Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITINGSão Paulo, 01509 900, Brazil
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Ghent University Hospital
RECRUITINGGhent, 9000, Belgium
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Gibbs Cancer Center
RECRUITINGSpartanburg, South Carolina, 29303, United States
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Gibbs Cancer Center and Research Institute Pelham
RECRUITINGGreer, South Carolina, 29650, United States
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Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
RECRUITINGFlorianópolis, 88020 210, Brazil
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Gustave Roussy
RECRUITINGVillejuif, 94800, France
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Hartford Hospital
RECRUITINGHartford, Connecticut, 06102, United States
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Henry Ford Cancer Detroit
RECRUITINGDetroit, Michigan, 48202, United States
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Hopital Saint Joseph
RECRUITINGParis, 75014, France
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Hopitaux universitaires de Strasbourg
RECRUITINGStrasbourg, 672098, France
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Hosp Univ Vall D Hebron
RECRUITINGBarcelona, 08035, Spain
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Hosp Virgen de La Victoria
RECRUITINGMálaga, 29010, Spain
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Hosp. Univ. 12 de Octubre
RECRUITINGMadrid, 28041, Spain
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Hosp. Univ. Ramon Y Cajal
RECRUITINGMadrid, 28034, Spain
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Hosp. de Jerez de La Frontera
RECRUITINGJerez de la Frontera, 11407, Spain
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Hospital Moinhos de Vento
RECRUITINGPorto Alegre, 90035-001, Brazil
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I.C.O. Rene Gauducheau
RECRUITINGSaint-Herblain, 44805, France
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ICON Cancer Care
RECRUITINGKurralta Park, 5037, Australia
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IN VIVO Sp. z o.o
RECRUITINGBydgoszcz, 85 048, Poland
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IOV IRCCS Padova
RECRUITINGPadova, 35128, Italy
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Institut Bergonie
RECRUITINGBordeaux, 33000, France
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Institut de Cancerologie de Lorraine
RECRUITINGVandœuvre-lès-Nancy, 54519, France
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Institute of Science Tokyo Hospital
RECRUITINGBunkyō City, 113 8519, Japan
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Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
RECRUITINGJoinville, 89201 260, Brazil
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Isala Kliniek
RECRUITINGZwolle, 8025 AB, Netherlands
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Istituto Clinico Humanitas
RECRUITINGRozzano, 20089, Italy
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Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
RECRUITINGWashington D.C., District of Columbia, 20016, United States
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Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21287, United States
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Kanazawa University Hospital
RECRUITINGKanazawa, 920 8641, Japan
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Keystone Urology Specialists
RECRUITINGLancaster, Pennsylvania, 17601, United States
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Klinikum Nuernberg Nord
RECRUITINGNuremberg, 90419, Germany
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Klinikum rechts der Isar der TU Muenchen
RECRUITINGMünchen, 81675, Germany
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Kobe University Hospital
RECRUITINGKobe, 650 0017, Japan
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Krankenhaus NorthWest
RECRUITINGFrankfurt am Main, 60488, Germany
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Kyushu University Hospital
RECRUITINGFukuoka, 812 8582, Japan
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Lakeridge Health
RECRUITINGOshawa, Ontario, L1G2B9, Canada
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Levine Cancer Institute
RECRUITINGCharlotte, North Carolina, 28204, United States
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Liga Norte Riograndense Contra O Cancer
RECRUITINGNatal, 59062 000, Brazil
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Linkou Chang Gung Memorial Hospital
RECRUITINGTaoyuan, 333, Taiwan
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Maastricht UMC
RECRUITINGMaastricht, 6229 HX, Netherlands
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Martini Ziekenhuis
RECRUITINGGroningen, 9728NT, Netherlands
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Martini-Klinik am UKE GmbH
RECRUITINGHamburg, 20246, Germany
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Michael E DeBakey VA Medical Center
RECRUITINGHouston, Texas, 77030, United States
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MidLantic Urology
RECRUITINGBala-Cynwyd, Pennsylvania, 19004, United States
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Mission Cancer Blood
RECRUITINGWaukee, Iowa, 50263, United States
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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NYU Langone Health Laura and Isaac Perlmutter Cancer Center
RECRUITINGNew York, New York, 10016, United States
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NYU Langone Hospital Long Island
RECRUITINGMineola, New York, 11501, United States
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NYU Langone Hospitals
RECRUITINGBrooklyn, New York, 11220, United States
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Nanjing Drum Tower Hospital
RECRUITINGNanjing, 210008, China
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Nantong Tumor Hospital
RECRUITINGNantong, 226300, China
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Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
RECRUITINGWarsaw, 02 781, Poland
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National Cancer Center
RECRUITINGGoyang-si, 10408, South Korea
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National Cancer Center Hospital East
RECRUITINGKashiwa, 277 8577, Japan
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National Hospital Organization Shikoku Cancer Center
RECRUITINGMatsuyama, 791-0280, Japan
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National Hospital Organization Tokyo Medical Center
RECRUITINGMeguro Ku, 152 8902, Japan
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National Taiwan University Hospital
RECRUITINGTaipei, 100, Taiwan
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Oregon Urology Institute
RECRUITINGSpringfield, Oregon, 97477, United States
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Ospedali Riuniti Foggia
RECRUITINGFoggia, 71122, Italy
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Pan American Center for Oncology Trials LLC
RECRUITINGRio Piedras, 00935, Puerto Rico
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Peking University First Hospital
RECRUITINGBeijing, 100034, China
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Penn Medicine Abramson Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Peter MacCallum Cancer Centre
RECRUITINGMelbourne, 3000, Australia
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Princess Alexandra Hospital
RECRUITINGWoolloongabba, 4102, Australia
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Princess Margaret Hospital
RECRUITINGToronto, Ontario, M5G 2C1, Canada
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Puerto Rico Medical Research Center
RECRUITINGSan Juan, 00917, Puerto Rico
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Ralph H Johnson Veterans Hospital
RECRUITINGCharleston, South Carolina, 29401, United States
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Reinier de Graaf Gasthuis
RECRUITINGDelft, 2625 AD, Netherlands
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Rocky Mountain Cancer Centers
RECRUITINGAurora, Colorado, 80012, United States
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Ronald Reagan UCLA Medical Center
RECRUITINGLos Angeles, California, 90095, United States
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Royal Marsden Hospital (Sutton)
RECRUITINGSutton, SM2 5PT, United Kingdom
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Saitama Medical University International Medical Center
RECRUITINGHidaka, 350 1298, Japan
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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San Francisco VA Medical Center
RECRUITINGSan Francisco, California, 94121, United States
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Severance Hospital Yonsei University Health System
RECRUITINGSeoul, 03722, South Korea
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Spaarne Gasthuis
RECRUITINGHoofddorp, 2134 TM, Netherlands
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Staedtisches Klinikum Braunschweig
RECRUITINGBraunschweig, 38126 DE, Germany
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Studienpraxis Urologie Nurtingen
RECRUITINGNürtingen, 72622, Germany
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Sun Yat Sen University Cancer Center
RECRUITINGGuangzhou, 510060, China
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Sunnybrook Health Sciences Center
RECRUITINGToronto, Ontario, M4N 3M5, Canada
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Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
RECRUITINGWarsaw, 04 073, Poland
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Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
RECRUITINGKoszalin, 75-581, Poland
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Taichung Veterans General Hospital
RECRUITINGTaichung, 40705, Taiwan
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Taipei Veterans General Hospital
RECRUITINGTaipei, 112, Taiwan
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Tennessee Oncology - Chattanooga
RECRUITINGChattanooga, Tennessee, 37404, United States
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Tennessee Oncology Nashville
RECRUITINGNashville, Tennessee, 37203, United States
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Tergooi
RECRUITINGHilversum, 1212 VG, Netherlands
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Texas Oncology West Texas
RECRUITINGWichita Falls, Texas, 76310, United States
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The Catholic University of Korea Seoul St Marys Hospital
RECRUITINGSeoul, 06591, South Korea
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The Christie NHS Foundation Trust Christie Hospital
RECRUITINGManchester, M20 4BX, United Kingdom
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The First Affiliated Hospital of Guangxi Medical University
RECRUITINGNanning, 530021, China
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The First Affiliated Hospital of Ningbo University
RECRUITINGNingbo, 315010, China
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The First Affiliated Hospital of Wenzhou Medical University
RECRUITINGWenzhou, 325000, China
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The First Affiliated Hospital of Xian Jiaotong University
RECRUITINGXi'an, 710061, China
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The First Bethune Hospital of Jilin University
RECRUITINGChangchun, 130021, China
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The Second Hospital Of Tianjin Medical University
RECRUITINGTianjin, 300211, China
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The Third People's Hospital of Chengdu
RECRUITINGChengdu, 500643, China
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Toho University Sakura Medical Center
RECRUITINGSakura, 285-8741, Japan
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Tungs' Taichung MetroHarbor Hospital
RECRUITINGTaichung, 435, Taiwan
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UPMC Cancer Centers
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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UT Southwestern Medical Center
RECRUITINGDallas, Texas, 75390, United States
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Universitaetsklinikum Duesseldorf
RECRUITINGDüsseldorf, 40225, Germany
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Universitaetsklinikum Essen
RECRUITINGEssen, 45147, Germany
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Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen
RECRUITINGHeidelberg, 69120, Germany
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Universitaetsklinikum Muenster
RECRUITINGMünster, 48149, Germany
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University College London Hospitals
RECRUITINGLondon, WC1E 6BT, United Kingdom
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University Hospital of Cleveland
RECRUITINGCleveland, Ohio, 44106, United States
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University Hospitals Birmingham NHS Foundation Trust
RECRUITINGBirmingham, B15 2TH, United Kingdom
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University Of Minnesota Medical Center
RECRUITINGMinneapolis, Minnesota, 55455, United States
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University of California at San Diego
RECRUITINGLa Jolla, California, 92093, United States
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University of Cincinnati
RECRUITINGCincinnati, Ohio, 45219, United States
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University of Colorado Cancer Center
RECRUITINGAurora, Colorado, 80045, United States
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University of Iowa Hospital and Clinics
RECRUITINGIowa City, Iowa, 52242, United States
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University of Michigan Health System
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of Washington
RECRUITINGSeattle, Washington, 98195, United States
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Uniwersytecki Szpital Kliniczny w Bialymstoku
RECRUITINGBialystok, 15 276, Poland
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Urologicum Duisburg
RECRUITINGDuisburg, 47169, Germany
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Urology Clinics of North Texas
COMPLETEDDallas, Texas, 75231, United States
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Utah Cancer Specialists
RECRUITINGSalt Lake City, Utah, 84106, United States
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VA Portland Health Care System
RECRUITINGPortland, Oregon, 97239, United States
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VA Puget Sound Healthcare System
RECRUITINGSeattle, Washington, 98108, United States
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Virginia Cancer Specialists
RECRUITINGFairfax, Virginia, 22031, United States
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Virginia Oncology Associates
RECRUITINGNorfolk, Virginia, 23502, United States
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Warringal Private Hospital
RECRUITINGHeidelberg, 3084, Australia
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West China Hospital of Sichuan University
RECRUITINGChengdu, 610041, China
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XCancer Omaha / Urology Cancer Center
RECRUITINGOmaha, Nebraska, 68130, United States
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Yokohama City University Hospital
RECRUITINGYokohama, 236 0004, Japan
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Yokohama City University Medical Center
RECRUITINGYokohama, 232 0024, Japan
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Yokosuka Kyosai Hospital
RECRUITINGYokosuka, 238 8558, Japan
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ZAS Augustinus
RECRUITINGWilrijk, 2610, Belgium
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Zhongnan Hospital Wu Han University
RECRUITINGWuhan, 430071, China
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