AzTrials
AzTrials

Prostatic Neoplasms, Castration-ResistantPhase 3KLK2-PASengerNCT07225946

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

A Phase 3 study testing Pasritamig, Docetaxel and Prednisone/Prednisolone in people with Prostatic Neoplasms, Castration-Resistant, run by Janssen Research & Development, LLC at 165 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans or death due to any cause) when compared to treatment with docetaxel in participants… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pasritamig, Docetaxel and Prednisone/Prednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
165 sitesin 17 countries
Study dates
19 Dec 2025to 7 Jun 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have histologically confirmed adenocarcinoma of the prostate
  • Have disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) and 99m^Tc bone scan as determined by the investigator
  • Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) (<= 1.73 nanomoles per Liter [nmol/L]) at screening
  • Have progressed by PSA or CT/MRI or 99m^Tc bone scan on at least 1 novel androgen receptor pathway inhibition (ARPI) but no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Who cannot join

  • Known history of either brain or leptomeningeal prostate cancer metastases
  • Participants with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated
  • Prior or concurrent second malignancy (other than the disease under study)
  • Received cytotoxic chemotherapy for prostate cancer in any setting
  • Received prior treatment with human kallikrein 2 (KLK-2) directed therapies

Trial locations and contacts

165 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

165 sites in 17 countries

United States65 sites, 65 recruiting

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

    Recruiting

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

    Recruiting

  • Texas Oncology

    Austin, Texas, 78731

    Recruiting

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

    Recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Recruiting

  • Johns Hopkins Medical Institutions

    Baltimore, Maryland, 21287

    Recruiting

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

    Recruiting

  • Massachusetts General

    Boston, Massachusetts, 02114

    Recruiting

  • Cooper Health System MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

    Recruiting

  • Gabrail Cancer Center

    Canton, Ohio, 44718

    Recruiting

  • Arizona Clinical Trials

    Chandler, Arizona, 85225

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45219

    Recruiting

  • Metrohealth Medical Center

    Cleveland, Ohio, 44109

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • AdventHealth Porter Oncology Research

    Denver, Colorado, 80210

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    Recruiting

  • St Elizabeth Healthcare

    Edgewood, Kentucky, 41017

    Recruiting

  • Vail Health Shaw Cancer Center

    Edwards, Colorado, 81632

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • MemorialCare Orange Coast Medical Center

    Fountain Valley, California, 92708

    Recruiting

  • Grand Valley Oncology

    Grand Junction, Colorado, 81505

    Recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Recruiting

  • Houston Metro Urology

    Houston, Texas, 77027

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Recruiting

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

    Recruiting

  • University Of California San Diego

    La Jolla, California, 92037

    Recruiting

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

    Recruiting

  • NHO Revive Research Institute, LLC

    Lincoln, Nebraska, 68506

    Recruiting

  • Duly Health and Care

    Lisle, Illinois, 60532

    Recruiting

  • Arkansas Urology

    Little Rock, Arkansas, 72211

    Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

    Recruiting

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

    Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Recruiting

  • NYU Langone Health Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016

    Recruiting

  • AdventHealth Orlando

    Orlando, Florida, 32803

    Recruiting

  • Memorial Cancer Institute

    Pembroke Pines, Florida, 33026

    Recruiting

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Kaiser Permanente Southern California

    Riverside, California, 92505

    Recruiting

  • HealthPartners Frauenshuh Cancer Center CRC West

    Saint Louis Park, Minnesota, 55426

    Recruiting

  • HealthPartners Cancer Center at Regions Hospital CRC East

    Saint Paul, Minnesota, 55101

    Recruiting

  • Sharp Center for Research

    San Diego, California, 92123

    Recruiting

  • Providence Saint John s Health Center

    Santa Monica, California, 90404

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    Recruiting

  • Fred Hutch Cancer Center Sloan Clinic 2

    Seattle, Washington, 98109

    Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

    Recruiting

  • Avera Medical Group

    Sioux Falls, South Dakota, 57105

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

    Recruiting

  • Oregon Urology Institute

    Springfield, Oregon, 97477

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Recruiting

  • Profound Research LLC at Cancer and Leukemia Center

    Sterling Heights, Michigan, 48314

    Recruiting

  • Texas Oncology 1

    Sugar Land, Texas, 77479

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10461

    Recruiting

  • Renovatio Clinical

    The Woodlands, Texas, 77380

    Recruiting

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204

    Recruiting

  • Prairie Lakes Health Care System

    Watertown, South Dakota, 57201

    Recruiting

  • Cancer Center of Kansas Heritage Plaza Medical Building

    Wichita, Kansas, 67214

    Recruiting

Other trials in United States

China16 sites, 16 recruiting

  • Peking University First Hospital

    Beijing, 100034

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Recruiting

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, 101100

    Recruiting

  • The Third People's Hospital of Chengdu

    Chengdu, 610014

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, 610041

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400030

    Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310009

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, 210009

    Recruiting

  • Huashan Hospital Fudan University

    Shanghai, 200031

    Recruiting

  • Shanghai General Hospital

    Shanghai, 200080

    Recruiting

  • Xinhua hospital,Shanghai Jiaotong University

    Shanghai, 200082

    Recruiting

  • The Second Hospital Of Tianjin Medical University

    Tianjin, 300211

    Recruiting

  • The Central Hospital of Wuhan

    Wuhan, 430014

    Recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

    Recruiting

Other trials in China

France8 sites, 8 recruiting

  • Institut Bergonie

    Bordeaux, 33076

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Recruiting

  • Centre Oscar Lambret

    Lille, 59000

    Recruiting

  • Centre Leon Berard

    Lyon, 69008

    Recruiting

  • Groupe Hospitalo-Universitaire Carémeau

    Nîmes, 30900

    Recruiting

  • Hopital Europeen Georges-Pompidou

    Paris, 75908

    Recruiting

  • Centre Eugene Marquis

    Rennes, 35062

    Recruiting

  • Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Japan7 sites, 7 recruiting

  • Juntendo University Hospital

    Bunkyō City, 113 8431

    Recruiting

  • Kansai Medical University Hospital

    Hirakata, 573-1191

    Recruiting

  • Kanazawa University Hospital

    Kanazawa, 920 8641

    Recruiting

  • Kobe University Hospital

    Kobe, 650 0017

    Recruiting

  • Kitasato University Hospital

    Sagamihara, 252-0375

    Recruiting

  • Shizuoka Cancer Center

    Sunto Gun, 411 8777

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, 232 0024

    Recruiting

Other trials in Japan

Spain7 sites, 7 recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

    Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hosp. Gral. Univ. J.M. Morales Meseguer

    Murcia, 30008

    Recruiting

  • Hosp. Virgen Macarena

    Seville, 41009

    Recruiting

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014

    Recruiting

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009

    Recruiting

Other trials in Spain

United Kingdom7 sites, 7 recruiting

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

    Recruiting

  • Beatson West Of Scotland Cancer Centre

    Glasgow, G12 0YN

    Recruiting

  • St Bartholomews Hospital

    London, EC1A 7BE

    Recruiting

  • The Royal Marsden NHS Trust

    London, SW3 6JJ

    Recruiting

  • The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

    Newcastle upon Tyne, NE7 7DN

    Recruiting

  • Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

    Preston, PR2 9HT

    Recruiting

  • Royal Marsden Hospital

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

Canada6 sites, 6 recruiting

  • Centre de Recherche du CHUM

    Montreal, Quebec, H2X 0A9

    Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • CHU de Quebec Universite Laval

    Québec, Quebec, G1R 2J6

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C4

    Recruiting

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z4E6

    Recruiting

  • British Columbia Cancer Agency Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5

    Recruiting

Other trials in Canada

Germany6 sites, 6 recruiting

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

    Recruiting

  • Urologicum Duisburg

    Duisburg, 47169

    Recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    Recruiting

  • Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie

    Hamburg, 20246

    Recruiting

  • Klinikum rechts der Isar an der Technischen Universitat Munchen

    München, 81675

    Recruiting

  • Studienpraxis Urologie Drs. Feyerabend

    Nürtingen, 72622

    Recruiting

Other trials in Germany

Italy6 sites, 6 recruiting

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

    Recruiting

  • ASL Napoli 2 Nord-SM delle Grazie Hospital

    Localita La Schiana Pozzuoli, 80078

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Recruiting

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

    Recruiting

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126

    Recruiting

Other trials in Italy

Turkey (Türkiye)6 sites, 6 recruiting

  • Adana City Hospital

    Adana, 01170

    Recruiting

  • Gulhane Training and Research Hospital

    Ankara, 06010

    Recruiting

  • Ankara University Medical Faculty

    Ankara, 06100

    Recruiting

  • Istanbul University Cerrahpasa tip Fakultesi

    Istanbul, 34096

    Recruiting

  • Koc Universitesi Hastanesi

    Istanbul, 34147

    Recruiting

  • Medicana International Izmir

    Izmir, 35170

    Recruiting

Other trials in Turkey (Türkiye)

Australia5 sites, 5 recruiting

  • Warringal Private Hospital

    Heidelberg, 3084

    Recruiting

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, 5037

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Recruiting

  • Sydney Adventist Hospital

    Wahroonga, 2076

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, 4102

    Recruiting

Other trials in Australia

Belgium5 sites, 5 recruiting

  • AZORG campus Aalst Moorselbaan

    Aalst, 9300

    Recruiting

  • ZAS Augustinus

    Antwerp, 2610

    Recruiting

  • AZ Maria Middelares

    Ghent, 9000

    Recruiting

  • Chu Helora Hospital La Louviere Site Jolimont

    La Louvière, 7100

    Recruiting

  • CHC MontLegia

    Liège, 4000

    Recruiting

Other trials in Belgium

Brazil5 sites, 5 recruiting

  • NAIC Nair Antunes Instituto do Cancer

    Bauru, 17033-495

    Recruiting

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

    Recruiting

  • Hospital Ana Nery Santa Cruz do Sul

    Santa Cruz do Sul, 96835-100

    Recruiting

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060 870

    Recruiting

  • Hospital Samaritano de Sao Paulo

    São Paulo, 01243 020

    Recruiting

Other trials in Brazil

Malaysia5 sites, 5 recruiting

  • Hospital Wanita dan Kanak-Kanak Sabah

    Kota Kinabalu, 88996

    Recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

    Recruiting

  • Pantai Hospital Kuala Lumpur

    Kuala Lumpur, 59100

    Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

    Recruiting

  • Hospital Umum Sarawak

    Kuching, 93586

    Recruiting

Other trials in Malaysia

South Korea5 sites, 5 recruiting

  • National Cancer Center

    Goyang-si, 10408

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

    Recruiting

Other trials in South Korea

Taiwan5 sites, 5 recruiting

  • China Medical University Hospital

    Taichung, 404

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407219

    Recruiting

  • Tungs' Taichung MetroHarbor Hospital

    Taichung, 435

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Puerto Rico1 site, 1 recruiting

  • Pan American Center for Oncology Trials LLC

    San Juan, 935

    Recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans or death due to any cause) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).

Being tested
Pasritamig, Docetaxel, Prednisone/Prednisolone
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PasritamigDrug

    Also called JNJ-78278343

    Pasritamig will be administered.

  • DocetaxelDrug

    Docetaxel will be administered.

  • Prednisone/PrednisoloneDrug

    Prednisone/Prednisolone will be administered.

Study groups in NCT07225946
Study groupRoleWhat they receive
Pasritamig+DocetaxelExperimentalParticipants will receive pasritamig along with docetaxel until the end of treatment (EOT) visit or until radiographic disease progression is confirmed by blinded independent central review (BICR), or any other protocol defined criteria are met.
Receives: Drug: Pasritamig; Drug: Docetaxel
DocetaxelActive comparatorParticipants will receive docetaxel along with prednisone/prednisolone as background medication.
Receives: Drug: Docetaxel; Drug: Prednisone/Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Progression-Free Survival (rPFS) by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan Assessed by Blinded Independent Central Review (BICR)

    rPFS by CT/MRI or bone scan is assessed by BICR and is defined as the time from the date of randomization to the first date of radiographic disease progression, or death due to any cause, whichever occurs first.

    Measured: Up to approximately 1 years 10 months

Secondary outcomes (20)

  1. Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Up to approximately 4 years 5 months

  2. Time to Symptomatic Progression (TSP)

    TSP is defined as the time from the date of randomization to the date of the first occurrence of any of the following: the use of external beam radiation to relieve cancer-related symptoms, the need for tumor-related surgical intervention, other cancer-related procedures, cancer-related morbid events, and initiation of a new systemic anticancer therapy because of cancer symptoms.

    Measured: Up to approximately 4 years 5 months

  3. Time to Subsequent Therapy (TST)

    TST is defined as time from randomization to the initiation of any subsequent systemic anticancer therapy for prostate cancer

    Measured: Up to approximately 4 years 5 months

  4. Time to Skeletal-Related Event (TSRE)

    TSRE is defined as the time from the date of randomization to the date of first occurrence of any of the following (whichever occurs first): the use of external beam radiation therapy to relieve skeletal symptoms, the need for tumor-related orthopedic surgical intervention, the occurrence of new bone fractures (cancer-related; vertebral or non-vertebral) or the occurrence of tumor-related spinal cord compression.

    Measured: Up to approximately 4 years 5 months

  5. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants who have measurable disease at baseline and have complete response (CR) or partial response (PR) or better by objective radiographic disease evaluation per response evaluation criteria in solid tumors (RECIST) version.1.1 response criteria and no bone progression as per prostate cancer working group 3 (PCWG3) as determined by the BICR.

    Measured: Up to approximately 4 years 5 months

  6. Duration of Response (DOR)

    DOR will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.

    Measured: Up to approximately 4 years 5 months

  7. Time to Prostate-Specific Antigen (PSA) Progression

    Time to PSA progression is defined as the time from randomization to the first date of documented PSA progression per prostate cancer working group 3 (PCWG3) criteria. PSA progression is defined as: (1) After a decline from baseline, PSA increases greater than or equal to (>=) 25% and >=2 nanogram per milliliter (ng/mL) above the nadir, confirmed by a second value >=3 weeks later (that is, a confirmed rising trend), or (2) If there is no decline from baseline, PSA increases >=25% and >=2 ng/mL from baseline after 12 weeks

    Measured: Up to approximately 4 years 5 months

  8. Proportion of Participants Who Achieved Prostate-Specific Antigen (PSA) 50 Response

    PSA-50 response is defined as the proportion of participants with a reduction in blood concentration of PSA (ng/mL) to 50% from baseline, confirmed by a second value, at least 3 weeks apart.

    Measured: Up to approximately 4 years 5 months

  9. Proportion of Participants Who Achieved Prostate-Specific Antigen (PSA) 90 Response

    PSA-90 response is defined as the proportion of participants with a reduction in blood concentration of PSA (ng/mL) to 90% from baseline, confirmed by a second value, at least 3 weeks apart.

    Measured: Up to approximately 4 years 5 months

  10. Duration of PSA Response

    Duration of a PSA response is the time taken to achieve a PSA response that is decrease in PSA from baseline by >= 50%.

    Measured: Baseline and up to approximately 4 years 5 months

  11. Progression Free Survival After Subsequent Therapy (PFS2)

    PFS2 is defined as the time from randomization to the date of progression (radiographic, clinical, or PSA progression) on the first subsequent anti-cancer (second progression), or death from any cause, whichever comes first.

    Measured: Up to approximately 4 years 5 months

  12. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An SAE: results in death, is life-threatening, requires inpatient hospitalization or prolonging hospitalization, results in disability, is a congenital birth defect, is a suspected transmission of any infectious agent via a medicinal product, is indicating suicidal ideation, is medically important. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.

    Measured: Up to approximately 4 years 5 months

  13. Number of Participants With Clinical Laboratory Abnormalities

    Participants with laboratory abnormalities (hematology, serum chemistry, coagulation, and tumor markers) will be reported.

    Measured: Up to approximately 4 years 5 months

  14. Change from Baseline in Health Related Quality of Life (HRQoL) as Assessed by Brief Pain Inventory-Short Form (BPI-SF)

    The BPI-SF was developed to measure both intensity or severity of pain and pain interference with daily life dimensions. It measures pain intensity via 4 questions, that is, "pain at its worst in the last 24 hours", "pain at its least in the last 24 hours", "pain on the average", and "pain you have right now". The BPI-SF assesses how much pain has interfered with the following 7 activities: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Higher score indicates more pain.

    Measured: Baseline up to approximately 4 years 5 months

  15. Change from Baseline in HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Cancer Module (EORTC QLQ-C30) Scale Score

    The EORTC QLQ-C30 - Version 3 is a self-administered, 30-item questionnaire measuring the health-related quality of life of participants with cancer. EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent". A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom.

    Measured: Baseline up to approximately 4 years 5 months

  16. Change from Baseline in HRQoL as Assessed by EORTC Quality of Life Questionnaire-Prostate (EORTC QLQ-PR25) Scale Score

    The EORTC QLQ-PR25 is a self-completed instrument was specifically designed for prostate cancer patients and includes 25 items that cover 6 dimensions: (1) PR URI (urinary symptoms, 8 items), (2) PR BOW (bowel symptoms, 4 items), (3) PR HTR (hormonal treatment-related symptoms, 6 items), (4) PR AID (incontinence aid, 1 item), (5) PR SAC (sexually active, 2 items); and (6) PR SFU (sexual function, 4 items). Higher scores on symptom domains (for example., urinary, bowel, etc.) indicate greater symptom burden and higher scores on function domains (for example, Sexual Function) indicate better functioning.

    Measured: Baseline up to approximately 4 years 5 months

  17. Change from Baseline in HRQoL as Assessed by European Quality of Life Visual Analog Scale (EQ-5D VAS) Score

    The EQ-5D descriptive system comprises 5 items across the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D includes a visual analog scale (EQ-VAS) that has endpoints labeled "best imaginable health state" and "worst imaginable health state" anchored at 100 and 0, respectively. Here, higher score indicates better quality of life.

    Measured: Baseline up to approximately 4 years 5 months

  18. Time to Sustained Worsening of Pain as Assessed by BPI-SF

    Time to sustained worsening of pain will be reported using BPI-SF. The BPI-SF was developed to measure both intensity or severity of pain and pain interference with daily life dimensions. It measures pain intensity via 4 questions, that is, "pain at its worst in the last 24 hours", "pain at its least in the last 24 hours", "pain on the average", and "pain you have right now". The BPI-SF assesses how much pain has interfered with the following 7 activities: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Higher score indicates more pain.

    Measured: Up to approximately 4 years 5 months

  19. Treatment Side Effect as Assessed by EORTC IL46 Score

    The EORTC IL46 is a single question that assesses bother (burden) of treatment. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".

    Measured: Up to approximately 4 years 5 months

  20. European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Scale Score

    The EQ-5D descriptive system comprises 5 items across the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L uses a 5-point Likert response scale ranging from "No problems" to "Extreme problems". Here, higher score indicates better quality of life.

    Measured: Up to approximately 4 years 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2025
  2. Study start19 Dec 2025
  3. Primary completion19 Nov 2027 (estimated)
  4. Study completion7 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07225946
Sponsor's protocol ID
78278343PCR3003
Other IDs
2025-522713-29-00, 2025
Acronym
KLK2-PASenger
Status last verified
Nov 2026
First submitted
6 Nov 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pasritamig, Docetaxel and Prednisone/Prednisolone in people with Prostatic Neoplasms, Castration-Resistant, run by Janssen Research & Development, LLC at 165 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States, China, France, Japan, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-Free Survival (rPFS) by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan Assessed by Blinded Independent Central Review (BICR) (time frame: Up to approximately 1 years 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07225946.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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