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Набира участници Фаза 3 NCT07213674

A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

Фаза 3 – широко изпитване преди одобрение
Заболявания: Metastatic Castration-resistant Prostate Cancer

Спонсор: Amgen

Налично на: БГ
Обобщение
The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).
Кой може да участва
Inclusion Criteria: * Participant has provided informed consent before initiation of any study-specific activities/procedures. * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. * Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted. * Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment. * Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria: * Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng/mL. * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions. * Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria). * Participants must have had prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required. * Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Adequate organ function. Exclusion Criteria: Disease Related: * Participants with a history of central nervous system (CNS) metastases. * Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor. Prior/Concomitant Therapy: * Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy. * Prior disease progression on or intolerance to abiraterone. * Prior treatment with any chemotherapy regimen in the mCRPC setting and/or \> 6 cycles of docetaxel treatment in the mHSPC setting. * Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions: * Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment. * Androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotrophin releasing hormone \[LHRH/GnRH\] analogue \[agonist/antagonist\]) is permitted. * Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment. * Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment. * Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities. * Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy. * Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment. * Prior CD3-directed therapy.
Интервенции
Xaluritamig
DRUG
Abiraterone acetate
DRUG
Docetaxel
DRUG
Cabazitaxel
DRUG
Места на провеждане 125
Австралия (5)
Monash Medical Centre
Clayton , Victoria
Austin Health, Austin Hospital
East Melbourne , Victoria
Icon Cancer Care Wesley
Herston , Queensland
Tasman Oncology Research
Southport , Queensland
Calvary Mater Newcastle Hospital
Waratah , New South Wales
Австрия (4)
Ordensklinikum Linz Elisabethinen
Linz
Universitaetsklinikum Sankt Poelten
Sankt Pölten
Krankenhaus der Barmherzigen Brueder Wien
Vienna
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna
Белгия (4)
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels
Universitair Ziekenhuis Gent
Ghent
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven
Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur
Yvoir
Канада (1)
Sir Mortimer B Davis - Jewish General Hospital
Montreal , Quebec
Франция (11)
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
Bordeaux
Centre Regional Francois Baclesse
Caen
Centre Jean Perrin
Clermont-Ferrand
Clinique Victor Hugo - Centre Jean Bernard
Le Mans
Centre Leon Berard
Lyon
Centre Antoine Lacassagne
Nice
Groupe Hospitalier Paris Saint Joseph
Paris
Hopital Europeen Georges Pompidou
Paris
Hopital Foch
Suresnes
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse
Gustave Roussy
Villejuif
Германия (11)
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin
Universitaetsklinikum Bonn
Bonn
Universitaetsklinikum Dresden
Dresden
Uniklinikum Erlangen
Erlangen
Universitaetsklinikum Essen
Essen
Universitaetsklinikum Hamburg Eppendorf
Hamburg
Universitaetsklinikum Heidelberg
Heidelberg
Universitatsklinikum Jena
Jena
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel
Universitaetsklinikum Ulm
Ulm
Universitaetsklinikum Wuerzburg
Würzburg
Гърция (8)
University General Hospital of Alexandroupoli
Alexandroupoli
Henry Dunant Hospital Center
Athens
Alexandra Hospital
Athens
Attikon University Hospital
Athens
University Hospital of Heraklion
Heraklion - Crete
General Oncological Hospital of Kifisia Oi Agioi Anargyroi
Kifissia, Athens
Athens Medical Center S.A - Iatriko Amarousiou
Marousi
European Interbalkan Medical Center
Thessaloniki
Италия (7)
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia
IRCCS Ospedale San Raffaele
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano
Ospedale Pederzoli Casa di Cura Privata
Peschiera del Garda
IRCCS Istituto Clinico Humanitas
Rozzano
Ospedale Santa Chiara Azienda Provinciale per i Servizi Sanitari Provincia Autonoma di Trento
Trento
Япония (15)
Nippon Medical School Hospital
Bunkyo-ku , Tokyo
Kyushu University Hospital
Fukuoka , Fukuoka
Saitama Medical University International Medical Center
Hidaka-shi , Saitama
Kanazawa University Hospital
Kanazawa , Ishikawa-ken
Kagawa University Hospital
Kita-gun , Kagawa-ken
Kobe University Hospital
Kobe , Hyōgo
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi , Saitama
TERMINATED
The Cancer institute Hospital of Japanese Foundation for Cancer Research
Koto-ku , Tokyo
National Hospital Organization Shikoku Cancer Center
Matsuyama , Ehime
The Jikei University Hospital
Minato-ku , Tokyo
Nagoya University Hospital
Nagoya , Aichi-ken
Osaka International Cancer Institute
Osaka , Osaka
Kitasato University Hospital
Sagamihara-shi , Kanagawa
The University of Osaka Hospital
Suita-shi , Osaka
Toyama University Hospital
Toyama , Toyama
Нидерландия (1)
Universitair Medisch Centrum Groningen
Groningen
Португалия (5)
Hospital da Luz, SA
Lisbon
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
Porto
Unidade Local de Saude de Gaia-Espinho, EPE
Vila Nova de Gaia
Сингапур (3)
National University Hospital
Singapore
National Cancer Centre Singapore
Singapore
Tan Tock Seng Hospital
Singapore
Южна Корея (3)
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System
Seoul
Asan Medical Center
Seoul
Испания (12)
Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
A Coruña , Galicia
Hospital Universitari Vall d Hebron
Barcelona , Catalonia
Hospital Clinic i Provincial de Barcelona
Barcelona , Catalonia
Hospital de la Santa Creu i Sant Pau
Barcelona , Catalonia
Hospital Universitario Lucus Augusti
Lugo , Galicia
Hospital Universitario Ramon y Cajal
Madrid
Hospital Clinico San Carlos
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , Madrid
Hospital Clinico Universitario Virgen de la Victoria
Málaga , Andalusia
Hospital Regional Universitario de Malaga
Málaga , Andalusia
Clinica Universidad de Navarra
Pamplona , Navarre
Швейцария (4)
Inselspital Bern
Bern
Centre Hospitalier Universitaire Vaudois
Lausanne
Kantonsspital Sankt Gallen
Sankt Gallen
Hirslanden Zurich
Zurich
Taiwan (3)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Великобритания (3)
Guys Hospital
London
Sarah Cannon Research Institute UK
London
Royal Marsden Hospital
Sutton
САЩ (25)
The Center for Cancer and Blood Disorders
Arlington , Texas
University of Maryland Greenebaum Cancer Center
Baltimore , Maryland
University of Virginia Cancer Center
Charlottesville , Virginia
University of Illinois Chicago
Chicago , Illinois
Oncology Hematology Care Incorporated
Cincinnati , Ohio
Rocky Mountain Cancer Centers
Denver , Colorado
City of Hope National Medical Center
Duarte , California
City of Hope Orange County Lennar Foundation Cancer Center
Duarte , California
Hematology Oncology Association of Central New York
East Syracuse , New York
Providence Saint Jude Medical Center
Fullerton , California
City of Hope Cancer Center Phoenix
Goodyear , Arizona
Barbara Ann Karmanos Cancer Institute
Lansing , Michigan
Virginia Cancer Specialists PC
Leesburg , Virginia
Norton Cancer Institute
Louisville , Kentucky
University of Minnesota Medical Center Fairview
Minneapolis , Minnesota
United States Oncology Regulatory Affairs Corporate Office
Nashville , Tennessee
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark , Delaware
City of Hope Atlanta
Newnan , Georgia
Virginia Oncology Associates
Norfolk , Virginia
Hightower Clinical
Oklahoma City , Oklahoma
University of Pittsburgh Medical Center
Pittsburgh , Pennsylvania
Texas Oncology Northeast Texas
Tyler , Texas
US Oncology Research Investigational Products Center
Tyler , Texas
University of Kansas Medical Center
Westwood , Kansas
City of Hope Chicago
Zion , Illinois
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
28.11.2025
Крайна дата
30.08.2032
Регистрационен номер
NCT07213674
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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