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New hope for Hard-to-Treat prostate cancer: Immune-Targeting drug combo enters final testing

NCT ID NCT07225946

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This Phase 3 trial tests whether adding pasritamig, a drug that directs the body's T-cells to attack prostate cancer cells, to standard chemotherapy (docetaxel) can slow cancer growth better than chemotherapy alone. The study involves 800 men with metastatic castration-resistant prostate cancer, a form that keeps growing despite low testosterone levels. Participants will receive either the combination or docetaxel alone, and researchers will track how long the cancer stays under control.

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) combined with docetaxel chemotherapy
What this could lead to
If successful, this combination could offer a new treatment option that slows cancer progression longer than chemotherapy alone for men with advanced prostate cancer.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The added drug may cause more side effects, and not all participants may benefit.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * 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 Exclusion criteria: * 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

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostatic neoplasms, castration-resistant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    152 sites in 17 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • ASL Napoli 2 Nord-SM delle Grazie Hospital

    RECRUITING

    Localita La Schiana Pozzuoli, 80078, Italy

  • AZ Maria Middelares

    RECRUITING

    Ghent, 9000, Belgium

  • AZORG campus Aalst Moorselbaan

    RECRUITING

    Aalst, 9300, Belgium

  • Adana City Hospital

    RECRUITING

    Adana, 01170, Turkey (Türkiye)

  • AdventHealth Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Ankara University Medical Faculty

    RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • Arizona Clinical Trials

    RECRUITING

    Chandler, Arizona, 85225, United States

  • Arkansas Urology

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Astera Cancer Care

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Avera Medical Group

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

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

    RECRUITING

    Torino, 10126, Italy

  • Azienda Ospedaliero Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Beatson West Of Scotland Cancer Centre

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, 100142, China

  • Beijing Luhe Hospital, Capital Medical University

    RECRUITING

    Beijing, 101100, China

  • British Columbia Cancer Agency

    RECRUITING

    Vancouver, British Columbia, V5Z4E6, Canada

  • British Columbia Cancer Agency Vancouver Island Centre

    RECRUITING

    Victoria, British Columbia, V8R 6V5, Canada

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    RECRUITING

    Santo André, 09060 870, Brazil

  • CHC MontLegia

    RECRUITING

    Liège, 4000, Belgium

  • CHU de Quebec Universite Laval

    RECRUITING

    Québec, Quebec, G1R 2J6, Canada

  • Cancer Center of Kansas Heritage Plaza Medical Building

    RECRUITING

    Wichita, Kansas, 67214, United States

  • Cancer and Blood Specialty Clinic

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Centre Eugene Marquis

    RECRUITING

    Rennes, 35062, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, 63011, France

  • Centre Leon Berard

    RECRUITING

    Lyon, 69008, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59000, France

  • Centre de Recherche du CHUM

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Chesapeake Urology Research Associates

    RECRUITING

    Towson, Maryland, 21204, United States

  • China Medical University Hospital

    RECRUITING

    Taichung, 404, Taiwan

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, 400030, China

  • Chu Helora Hospital La Louviere Site Jolimont

    RECRUITING

    La Louvière, 7100, Belgium

  • Colorado Clinical Research

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • Duly Health and Care

    RECRUITING

    Lisle, Illinois, 60532, United States

  • East Jefferson General Hospital

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Fred Hutch Cancer Center Sloan Clinic 2

    RECRUITING

    Seattle, Washington, 98109, United States

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Grand Valley Oncology

    RECRUITING

    Grand Junction, Colorado, 81505, United States

  • Groupe Hospitalo-Universitaire Carémeau

    RECRUITING

    Nîmes, 30900, France

  • Gulhane Training and Research Hospital

    RECRUITING

    Ankara, 06010, Turkey (Türkiye)

  • Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • HealthPartners Cancer Center at Regions Hospital CRC East

    RECRUITING

    Saint Paul, Minnesota, 55101, United States

  • HealthPartners Frauenshuh Cancer Center CRC West

    RECRUITING

    Saint Louis Park, Minnesota, 55426, United States

  • Hopital Europeen Georges-Pompidou

    RECRUITING

    Paris, 75908, France

  • Hosp. Clinico Univ. Lozano Blesa

    RECRUITING

    Zaragoza, 50009, Spain

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

    RECRUITING

    Murcia, 30008, Spain

  • Hosp. Gral. Univ. Valencia

    RECRUITING

    Valencia, 46014, Spain

  • Hosp. Univ. 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hosp. Univ. Germans Trias I Pujol

    RECRUITING

    Badalona, 08916, Spain

  • Hosp. Univ. Ramon Y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hosp. Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital Ana Nery Santa Cruz do Sul

    RECRUITING

    Santa Cruz do Sul, 96835-100, Brazil

  • Hospital Kuala Lumpur

    RECRUITING

    Kuala Lumpur, 50586, Malaysia

  • Hospital Samaritano de Sao Paulo

    RECRUITING

    São Paulo, 01243 020, Brazil

  • Hospital Umum Sarawak

    RECRUITING

    Kuching, 93586, Malaysia

  • Hospital Wanita dan Kanak-Kanak Sabah

    RECRUITING

    Kota Kinabalu, 88996, Malaysia

  • Houston Metro Urology

    RECRUITING

    Houston, Texas, 77027, United States

  • Huashan Hospital Fudan University

    RECRUITING

    Shanghai, 200031, China

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Icon Cancer Centre Kurralta Park

    RECRUITING

    Kurralta Park, 5037, Australia

  • Institut Bergonie

    RECRUITING

    Bordeaux, 33076, France

  • Istanbul University Cerrahpasa tip Fakultesi

    RECRUITING

    Istanbul, 34096, Turkey (Türkiye)

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Istituto Nazionale Tumori Regina Elena

    RECRUITING

    Roma, 00144, Italy

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Johns Hopkins Medical Institutions

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Juntendo University Hospital

    RECRUITING

    Bunkyō City, 113 8431, Japan

  • Kaiser Permanente Southern California

    RECRUITING

    Riverside, California, 92505, United States

  • Kanazawa University Hospital

    RECRUITING

    Kanazawa, 920 8641, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, 573-1191, Japan

  • Kitasato University Hospital

    RECRUITING

    Sagamihara, 252-0375, Japan

  • Klinikum rechts der Isar an der Technischen Universitat Munchen

    RECRUITING

    München, 81675, Germany

  • Kobe University Hospital

    RECRUITING

    Kobe, 650 0017, Japan

  • Koc Universitesi Hastanesi

    RECRUITING

    Istanbul, 34147, Turkey (Türkiye)

  • Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

    RECRUITING

    Preston, PR2 9HT, United Kingdom

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

    RECRUITING

    Mineola, New York, 11501, United States

  • Lehigh Valley Hospital

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Liga Norte Riograndense Contra O Cancer

    RECRUITING

    Natal, 59062 000, Brazil

  • Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan, 333, Taiwan

  • Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie

    RECRUITING

    Hamburg, 20246, Germany

  • Medicana International Izmir

    RECRUITING

    Izmir, 35170, Turkey (Türkiye)

  • MemorialCare Orange Coast Medical Center

    RECRUITING

    Fountain Valley, California, 92708, United States

  • MidLantic Urology

    RECRUITING

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • NAIC Nair Antunes Instituto do Cancer

    RECRUITING

    Bauru, 17033-495, Brazil

  • NHO Revive Research Institute, LLC

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • NYU Langone Health Laura and Isaac Perlmutter Cancer Center

    RECRUITING

    New York, New York, 10016, United States

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, 210009, China

  • National Cancer Center

    RECRUITING

    Goyang-si, 10408, South Korea

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704, Taiwan

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Oregon Urology Institute

    RECRUITING

    Springfield, Oregon, 97477, United States

  • Pan American Center for Oncology Trials LLC

    RECRUITING

    San Juan, 935, Puerto Rico

  • Pantai Hospital Kuala Lumpur

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Penn State Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, 3000, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, 4102, Australia

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • Profound Research LLC at Cancer and Leukemia Center

    RECRUITING

    Sterling Heights, Michigan, 48314, United States

  • Providence Saint John s Health Center

    RECRUITING

    Santa Monica, California, 90404, United States

  • Rocky Mountain Cancer Centers

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Shanghai General Hospital

    RECRUITING

    Shanghai, 200080, China

  • Sharp Center for Research

    RECRUITING

    San Diego, California, 92123, United States

  • Shizuoka Cancer Center

    RECRUITING

    Sunto Gun, 411 8777, Japan

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, 310009, China

  • St Bartholomews Hospital

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • St Elizabeth Healthcare

    RECRUITING

    Edgewood, Kentucky, 41017, United States

  • Studienpraxis Urologie Drs. Feyerabend

    RECRUITING

    Nürtingen, 72622, Germany

  • Sun Yat Sen University Cancer Center

    RECRUITING

    Guangzhou, 510060, China

  • Sydney Adventist Hospital

    RECRUITING

    Wahroonga, 2076, Australia

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 407219, Taiwan

  • Tennessee Cancer Specialists

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Texas Oncology

    RECRUITING

    Austin, Texas, 78731, United States

  • Texas Oncology 1

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • The Catholic University of Korea Seoul St Marys Hospital

    RECRUITING

    Seoul, 06591, South Korea

  • The Central Hospital of Wuhan

    RECRUITING

    Wuhan, 430014, China

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, 510120, China

  • The First Affiliated Hospital of Xian Jiaotong University

    RECRUITING

    Xi'an, 710061, China

  • The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • The Ottawa Hospital Cancer Centre

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • The Royal Marsden NHS Trust

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • The Second Hospital Of Tianjin Medical University

    RECRUITING

    Tianjin, 300211, China

  • The Third People's Hospital of Chengdu

    RECRUITING

    Chengdu, 610014, China

  • Tungs' Taichung MetroHarbor Hospital

    RECRUITING

    Taichung, 435, Taiwan

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitatsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, 01307, Germany

  • University Malaya Medical Centre

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • University Of California San Diego

    RECRUITING

    La Jolla, California, 92037, United States

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • Urologicum Duisburg

    RECRUITING

    Duisburg, 47169, Germany

  • Vail Health Shaw Cancer Center

    RECRUITING

    Edwards, Colorado, 81632, United States

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

  • Velindre Cancer Centre

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Warringal Private Hospital

    RECRUITING

    Heidelberg, 3084, Australia

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • West China Hospital Sichuan University

    RECRUITING

    Chengdu, 610041, China

  • Winship Cancer Institute Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Xinhua hospital,Shanghai Jiaotong University

    RECRUITING

    Shanghai, 200082, China

  • Yokohama City University Medical Center

    RECRUITING

    Yokohama, 232 0024, Japan

  • ZAS Augustinus

    RECRUITING

    Antwerp, 2610, Belgium

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