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A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT07164443 · Janssen Research & Development, LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer
About this study
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 combination with best supportive care (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).
Eligibility criteria
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
* 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 should 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: Should 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. Participants who cannot continue taxane therapy because of a documented Grade\>=3 taxane related IRR are eligible for enrollment, even if they received fewer than 2 prior cycles of taxane treatment
Radioligand therapy: Should 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): Should 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 \>= 30 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (\<=) 5 times the Upper Limit of Normal (ULN) C) Serum total bilirubin \<= 3 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
Study design
Enrollment target: 663 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-09-02
Estimated completion: 2028-05-30
Last updated: 2026-04-13
Interventions
Biological: PasritamigOther: PlaceboDrug: Best Supportive Care (BSC)
Primary outcomes
- • Overall Survival (OS) (Up to 2 years and 8 months)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (163)
University of California at San DiegoRecruiting
La Jolla, California, United States
Ronald Reagan UCLA Medical CenterRecruiting
Los Angeles, California, United States
Rocky Mountain Cancer CentersRecruiting
Aurora, Colorado, United States
University of Colorado Cancer CenterRecruiting
Aurora, Colorado, United States
Colorado Clinical ResearchRecruiting
Lakewood, Colorado, United States
Hartford HospitalRecruiting
Hartford, Connecticut, United States
Johns Hopkins Office of Capital Region Research - Sibley Memorial HospitalRecruiting
Washington D.C., District of Columbia, United States
Bay Pines VA Healthcare SystemRecruiting
Bay Pines, Florida, United States
Florida Cancer Specialists & Research InstituteRecruiting
Fort Myers, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
East Jefferson General HospitalRecruiting
Metairie, Louisiana, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
University of Michigan Health SystemRecruiting
Ann Arbor, Michigan, United States
Henry Ford Cancer DetroitRecruiting
Detroit, Michigan, United States
University Of Minnesota Medical CenterRecruiting
Minneapolis, Minnesota, United States
XCancer Omaha / Urology Cancer CenterRecruiting
Omaha, Nebraska, United States
NYU Langone HospitalsRecruiting
Brooklyn, New York, United States
NYU Langone Hospital Long IslandRecruiting
Mineola, New York, United States
NYU Langone Health Laura and Isaac Perlmutter Cancer CenterRecruiting
New York, New York, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
University of CincinnatiRecruiting
Cincinnati, Ohio, United States
University Hospital of ClevelandRecruiting
Cleveland, Ohio, United States
Compass OncologyRecruiting
Portland, Oregon, United States
Oregon Urology InstituteRecruiting
Springfield, Oregon, United States
MidLantic UrologyRecruiting
Bala-Cynwyd, Pennsylvania, United States
Keystone Urology SpecialistsRecruiting
Lancaster, Pennsylvania, United States
Penn Medicine Abramson Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
UPMC Cancer CentersRecruiting
Pittsburgh, Pennsylvania, United States
Ralph H Johnson Veterans HospitalRecruiting
Charleston, South Carolina, United States
Gibbs Cancer Center and Research Institute PelhamRecruiting
Greer, South Carolina, United States
Carolina Urologic Research CenterRecruiting
Myrtle Beach, South Carolina, United States
Gibbs Cancer CenterRecruiting
Spartanburg, South Carolina, United States
Tennessee Oncology - ChattanoogaRecruiting
Chattanooga, Tennessee, United States
Tennessee Oncology NashvilleRecruiting
Nashville, Tennessee, United States
Urology Clinics of North TexasRecruiting
Dallas, Texas, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Michael E DeBakey VA Medical CenterRecruiting
Houston, Texas, United States
Texas Oncology West TexasRecruiting
Wichita Falls, Texas, United States
Utah Cancer SpecialistsRecruiting
Salt Lake City, Utah, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Blue Ridge Cancer CareRecruiting
Roanoke, Virginia, United States
VA Puget Sound Healthcare SystemRecruiting
Seattle, Washington, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States
University of WashingtonRecruiting
Seattle, Washington, United States
Warringal Private HospitalRecruiting
Heidelberg, Australia
ICON Cancer CareRecruiting
Kurralta Park, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Australia
Fiona Stanley HospitalRecruiting
Murdoch, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Australia
AZ Sint-JanRecruiting
Bruges, Belgium
Cliniques Universitaires Saint LucRecruiting
Brussels, Belgium
AZ Maria MiddelaresRecruiting
Ghent, Belgium
Ghent University HospitalRecruiting
Ghent, Belgium
Az GroeningeRecruiting
Kortrijk, Belgium
Chu Helora Hospital La Louviere Site JolimontRecruiting
La Louvière, Belgium
CHC MontLegiaRecruiting
Liège, Belgium
Clinique Saint PierreRecruiting
Ottignies, Belgium
ZAS AugustinusRecruiting
Wilrijk, Belgium
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPENRecruiting
Florianópolis, Brazil
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e OncologiaRecruiting
Joinville, Brazil
Liga Norte Riograndense Contra O CancerRecruiting
Natal, Brazil
Associacao Hospitalar Moinhos de VentoRecruiting
Porto Alegre, Brazil
Fundacao Antonio Prudente A C Camargo Cancer CenterRecruiting
São Paulo, Brazil
Arthur J E Child Comprehensive Cancer CentreRecruiting
Calgary, Alberta, Canada
BC Cancer VancouverRecruiting
Vancouver, British Columbia, Canada
Lakeridge HealthRecruiting
Oshawa, Ontario, Canada
Sunnybrook Health Sciences CenterRecruiting
Toronto, Ontario, Canada
Princess Margaret HospitalRecruiting
Toronto, Ontario, Canada
CHU de Quebec Universite LavalRecruiting
Québec, Quebec, Canada
Peking University First HospitalRecruiting
Beijing, China
The First Bethune Hospital of Jilin UniversityRecruiting
Changchun, China
West China Hospital of Sichuan UniversityRecruiting
Chengdu, China
Chongqing University Cancer HospitalRecruiting
Chongqing, China
Sun Yat Sen University Cancer CenterRecruiting
Guangzhou, China
Nanjing Drum Tower HospitalRecruiting
Nanjing, China
The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
Nanning, China
Nantong Tumor HospitalRecruiting
Nantong, China
The First Affiliated Hospital of Ningbo UniversityRecruiting
Ningbo, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, China
The Second Hospital Of Tianjin Medical UniversityRecruiting
Tianjin, China
The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Wenzhou, China
Zhongnan Hospital Wu Han UniversityRecruiting
Wuhan, China
The First Affiliated Hospital of Xian Jiaotong UniversityRecruiting
Xi'an, China
Institut BergonieRecruiting
Bordeaux, France
CHRU Brest - Hopital MorvanRecruiting
Brest, France
Centre Georges Francois LeclercRecruiting
Dijon, France
Centre Oscar LambretRecruiting
Lille, France
Centre Leon BerardRecruiting
Lyon, France
Hopital Saint JosephRecruiting
Paris, France
CHU Lyon SudRecruiting
Pierre-Bénite, France
I.C.O. Rene GauducheauRecruiting
Saint-Herblain, France
Hopitaux universitaires de StrasbourgRecruiting
Strasbourg, France
Institut de Cancerologie de LorraineRecruiting
Vandœuvre-lès-Nancy, France
Gustave RoussyRecruiting
Villejuif, France
Staedtisches Klinikum BraunschweigRecruiting
Braunschweig, Germany
Urologicum DuisburgRecruiting
Duisburg, Germany
Universitaetsklinikum DuesseldorfRecruiting
Düsseldorf, Germany
Universitaetsklinikum EssenRecruiting
Essen, Germany
Krankenhaus NorthWestRecruiting
Frankfurt am Main, Germany
Martini-Klinik am UKE GmbHRecruiting
Hamburg, Germany
Universitaetsklinikum Heidelberg Nationales Centrum fuer TumorerkrankungenRecruiting
Heidelberg, Germany
Klinikum rechts der Isar der TU MuenchenRecruiting
München, Germany
Universitaetsklinikum MuensterRecruiting
Münster, Germany
Klinikum Nuernberg NordRecruiting
Nuremberg, Germany
Studienpraxis Urologie NurtingenRecruiting
Nürtingen, Germany
Ospedali Riuniti FoggiaRecruiting
Foggia, Italy
Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
Milan, Italy
Azienda Ospedaliera Universitaria Federico IIRecruiting
Naples, Italy
IOV IRCCS PadovaRecruiting
Padova, Italy
Azienda Di Rilievo Nazionale E Di Alta SpecializzazioneRecruiting
Palermo, Italy
Fondazione Policlinico Universitario A Gemelli IRCCSRecruiting
Roma, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Institute of Science Tokyo HospitalRecruiting
Bunkyō City, Japan
Kyushu University HospitalRecruiting
Fukuoka, Japan
Saitama Medical University International Medical CenterRecruiting
Hidaka, Japan
Kanazawa University HospitalRecruiting
Kanazawa, Japan
Kobe University HospitalRecruiting
Kobe, Japan
National Hospital Organization Shikoku Cancer CenterRecruiting
Matsuyama, Japan
National Hospital Organization Tokyo Medical CenterRecruiting
Meguro Ku, Japan
Toho University Sakura Medical CenterRecruiting
Sakura, Japan
Yokohama City University Medical CenterRecruiting
Yokohama, Japan
Yokohama City University HospitalRecruiting
Yokohama, Japan
Yokosuka Kyosai HospitalRecruiting
Yokosuka, Japan
Reinier de Graaf GasthuisRecruiting
Delft, Netherlands
Martini ZiekenhuisRecruiting
Groningen, Netherlands
TergooiRecruiting
Hilversum, Netherlands
Spaarne GasthuisRecruiting
Hoofddorp, Netherlands
Maastricht UMCRecruiting
Maastricht, Netherlands
Canisius-Wilhelmina ZHRecruiting
Nijmegen, Netherlands
Erasmus MCRecruiting
Rotterdam, Netherlands
Isala KliniekRecruiting
Zwolle, Netherlands
Uniwersytecki Szpital Kliniczny w BialymstokuRecruiting
Bialystok, Poland
IN VIVO Sp. z o.oRecruiting
Bydgoszcz, Poland
Szpital Wojewodzki im Mikolaja Kopernika w KoszalinieRecruiting
Koszalin, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyRecruiting
Warsaw, Poland
Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O ORecruiting
Warsaw, Poland
Pan American Center for Oncology Trials LLCRecruiting
Rio Piedras, Puerto Rico
Puerto Rico Medical Research CenterRecruiting
San Juan, Puerto Rico
Chungnam National University HospitalRecruiting
Daejeon, South Korea
National Cancer CenterRecruiting
Goyang-si, South Korea
Chonnam National University Hwasun HospitalRecruiting
Hwasungun, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
The Catholic University of Korea Seoul St Marys HospitalRecruiting
Seoul, South Korea
Hosp Univ Vall D HebronRecruiting
Barcelona, Spain
Hosp. de Jerez de La FronteraRecruiting
Jerez de la Frontera, Spain
Hosp. Univ. Ramon Y CajalRecruiting
Madrid, Spain
Hosp. Univ. 12 de OctubreRecruiting
Madrid, Spain
Hosp Virgen de La VictoriaRecruiting
Málaga, Spain
Chang Gung Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
Tungs' Taichung MetroHarbor HospitalRecruiting
Taichung, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Linkou Chang Gung Memorial HospitalRecruiting
Taoyuan District, Taiwan
University Hospitals Birmingham NHS Foundation TrustRecruiting
Birmingham, United Kingdom
University College London HospitalsRecruiting
London, United Kingdom
The Christie NHS Foundation Trust Christie HospitalRecruiting
Manchester, United Kingdom
Royal Marsden Hospital (Sutton)Recruiting
Sutton, United Kingdom