Clinical trial • Phase III • Oncology
JNJ-78278343 for Metastatic castration-resistant prostate cancer
Phase III trial of JNJ-78278343 for Metastatic castration-resistant prostate cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic castration-resistant prostate cancer
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 07-11-2025
- First CTIS Authorization Date
- 09-03-2026
Trial design
Randomised, open-label, docetaxel (intravenous chemotherapy; product: docetaxel aqvida 20 mg/ml concentrate for infusion) and prednisone (oral tablets; product: prednison acis 5 mg). dose and schedule not specified in the ctis record.-controlled Phase III trial in Belgium, France, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Docetaxel (intravenous chemotherapy; product: Docetaxel AqVida 20 mg/ml concentrate for infusion) and Prednisone (oral tablets; product: Prednison acis 5 mg). Dose and schedule not specified in the CTIS record.
- Target Sample Size
- 629
- Trial Duration For Participant
- 1649
Eligibility
Recruits 629 No vulnerable population selected in the trial record. Subject information and informed consent forms are provided (multiple country-specific versions). A 'Child Expose to IMP Privacy Appendix' document exists in the Italian document set, however the trial population is specified as adult patients and isVulnerablePopulationSelected is false..
- Vulnerable Population
- No vulnerable population selected in the trial record. Subject information and informed consent forms are provided (multiple country-specific versions). A 'Child Expose to IMP Privacy Appendix' document exists in the Italian document set, however the trial population is specified as adult patients and isVulnerablePopulationSelected is false.
Inclusion criteria
- {"criterion_text":"- 1. Have progressive metastatic castrate-resistant disease defined as at least one of the following: - PSA level ≥2 ng/mL that has increased on at least 2 successive occasions at least 1 week apart. - Progressive disease or new lesion(s) in the lymph nodes, bones, or viscera as defined by RECIST v1.1 and/or in bone scan per PCWG3 while on medical or surgical castration.\n- 2. Have progressed on at least 1 novel ARPI but received no more than 2 different ARPI (eg, abiraterone acetate, apalutamide, enzalutamide, darolutamide) for any stage of disease. Must have discontinued ARPI before randomization into the study.\n- 3. Have the following laboratory values during the screening period: - Hemoglobin ≥9.0 g/dL - Neutrophils ≥1.5 x 10^9/L - Platelets ≥100 x 10^9/L Note, transfusion or growth factor usage within 14 days of randomization is not allowed."}
Exclusion criteria
- {"criterion_text":"- 1. Received cytotoxic chemotherapy for prostate cancer (eg, docetaxel, cabazitaxel, mitoxantrone, etc).\n- 2. Received prior treatment for prostate cancer with: - CD3 redirector therapies or - Radiopharmaceutical agents or - Immunotherapy agents for prostate cancer (eg, sipuleucel-T, PD-1 inhibitors, T-cell redirectors, costimulatory agents, etc) or - PARP inhibitors (unless for BRCA1/2 mutations) or - Any other investigational agent for the treatment of mCRPC\n- 3. Patients with known BRCA 1/2 mutations (germline or somatic) who have not received treatment with a PARP inhibitor, unless not available or contraindicated."}
Endpoints
Primary endpoints
- {"endpoint_text":"- rPFS, measured as the time from randomization to the time of radiographic disease progression per PCWG3 and RECIST v1.1 as assessed by BICR on CT/MRI or bone scan, or death from any cause, whichever occurs first.","definition_or_measurement_approach":"Measured as the time from randomization to radiographic disease progression per PCWG3 and RECIST v1.1 assessed by BICR on CT/MRI or bone scan, or death from any cause, whichever occurs first."}
Recruitment
- Planned Sample Size
- 629
- Recruitment Window Months
- 54
- Consent Approach
- Informed consent obtained using Subject Information Sheets and Informed Consent Forms (multiple country- and language-specific versions listed). ICF/SIS documents include adult ICFs and appendices for optional samples, pregnant partner, treatment after progression, withdrawal, and wallet cards. Languages and country-specific versions are available (Dutch, French, German, Italian, Spanish, English as indicated by document titles). No explicit assent process for minors is described in the CTIS record.
Methods
- Site-based recruitment using country-specific recruitment arrangements documents (document titles include 'Recruitment Arrangements' for BE/FR/DE/IT/ES).
- Printed materials: patient flyers and patient posters (country-specific versions listed for BE, FR, DE, IT, ES).
- Caregiver-targeted materials: caregiver guides (country-specific versions listed).
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 171
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-02-2026
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 21
- Number Of Sites
- 5
- Number Of Participants
- 30
Sites
- Site Name
- Azorg
- Department Name
- Urology
- Principal Investigator Name
- Edward Lambert
- Principal Investigator Email
- urologie.aalst@olvz-aalst.be
- Contact Person Name
- Edward Lambert
- Contact Person Email
- urologie.aalst@olvz-aalst.be
- Site Name
- Ziekenhuis Aan De Stroom
- Department Name
- Oncology
- Principal Investigator Name
- Tom Van den Mooter
- Principal Investigator Email
- tom.vandenmooter@gza.be
- Contact Person Name
- Tom Van den Mooter
- Contact Person Email
- tom.vandenmooter@gza.be
- Site Name
- CHC MontLegia
- Department Name
- Oncology
- Principal Investigator Name
- Geoffrey Matus
- Principal Investigator Email
- geoffrey.matus@chc.be
- Contact Person Name
- Geoffrey Matus
- Contact Person Email
- geoffrey.matus@chc.be
- Site Name
- CHU Helora
- Department Name
- Oncology
- Principal Investigator Name
- Guillaume Grisay
- Principal Investigator Email
- guillaume.grisay@jolimont.be
- Contact Person Name
- Guillaume Grisay
- Contact Person Email
- guillaume.grisay@jolimont.be
- Site Name
- Az Maria Middelares Gent
- Department Name
- Oncology
- Principal Investigator Name
- Christof Vulsteke
- Principal Investigator Email
- christof.vulsteke@azmmsj.be
- Contact Person Name
- Christof Vulsteke
- Contact Person Email
- christof.vulsteke@azmmsj.be
France
- Earliest CTIS Part Ii Submission Date
- 12-03-2026
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 11
- Number Of Sites
- 9
- Number Of Participants
- 33
Sites
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Medical Oncology
- Principal Investigator Name
- Brigitte Laguerre
- Principal Investigator Email
- b.laguerre@rennes.unicancer.fr
- Contact Person Name
- Brigitte Laguerre
- Contact Person Email
- b.laguerre@rennes.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology
- Principal Investigator Name
- Ronan Flippot
- Principal Investigator Email
- Ronan.flippot@gustaveroussy.fr
- Contact Person Name
- Ronan Flippot
- Contact Person Email
- Ronan.flippot@gustaveroussy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medical Oncology
- Principal Investigator Name
- Stephane Oudard
- Principal Investigator Email
- stephane.oudard@aphp.fr
- Contact Person Name
- Stephane Oudard
- Contact Person Email
- stephane.oudard@aphp.fr
- Site Name
- Centre Jean Perrin
- Department Name
- Medical Oncology
- Principal Investigator Name
- Hakim Mahammedi
- Principal Investigator Email
- hakim.mahammedi@clermont.unicancer.fr
- Contact Person Name
- Hakim Mahammedi
- Contact Person Email
- hakim.mahammedi@clermont.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Medical Oncology
- Principal Investigator Name
- Nadine Houede
- Principal Investigator Email
- Nadine.houede@chu-nimes.fr
- Contact Person Name
- Nadine Houede
- Contact Person Email
- Nadine.houede@chu-nimes.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Medical Oncology
- Principal Investigator Name
- Aurelien Carnot
- Principal Investigator Email
- a-carnot@o-lambret.fr
- Contact Person Name
- Aurelien Carnot
- Contact Person Email
- a-carnot@o-lambret.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Armelle Vinceneux
- Principal Investigator Email
- armelle.vinceneux@lyon.unicancer.fr
- Contact Person Name
- Armelle Vinceneux
- Contact Person Email
- armelle.vinceneux@lyon.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Guilhem Roubaud
- Principal Investigator Email
- g.roubaud@bordeaux.unicancer.fr
- Contact Person Name
- Guilhem Roubaud
- Contact Person Email
- g.roubaud@bordeaux.unicancer.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis (duplicate entry in list)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Brigitte Laguerre
- Principal Investigator Email
- b.laguerre@rennes.unicancer.fr
- Contact Person Name
- Brigitte Laguerre
- Contact Person Email
- b.laguerre@rennes.unicancer.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 25-02-2026
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 15
- Number Of Sites
- 7
- Number Of Participants
- 33
Sites
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Klinik und Poliklinik für Urologie
- Principal Investigator Name
- Séverine Banek
- Principal Investigator Email
- severine.banek@ukdd.de
- Contact Person Name
- Séverine Banek
- Contact Person Email
- severine.banek@ukdd.de
- Site Name
- Urologicum Duisburg
- Principal Investigator Name
- Eva Hellmis
- Principal Investigator Email
- hellmis@urologicum-duisburg.de
- Contact Person Name
- Eva Hellmis
- Contact Person Email
- hellmis@urologicum-duisburg.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Department of Oncology
- Principal Investigator Name
- Gunhild von Amsberg
- Principal Investigator Email
- g.von-amsberg@uke.de
- Contact Person Name
- Gunhild von Amsberg
- Contact Person Email
- g.von-amsberg@uke.de
- Site Name
- Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
- Principal Investigator Name
- Tilman Todenhöfer
- Principal Investigator Email
- todenhoefer@studienurologie.de
- Contact Person Name
- Tilman Todenhöfer
- Contact Person Email
- todenhoefer@studienurologie.de
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Urologische Klinik und Poliklinik
- Principal Investigator Name
- Margitta Retz
- Principal Investigator Email
- Margitta.retz@tum.de
- Contact Person Name
- Margitta Retz
- Contact Person Email
- Margitta.retz@tum.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik und Poliklinik für Urologie
- Principal Investigator Name
- Christopher Darr
- Principal Investigator Email
- christopher.darr@uk-essen.de
- Contact Person Name
- Christopher Darr
- Contact Person Email
- christopher.darr@uk-essen.de
- Site Name
- University Medical Center Hamburg-Eppendorf (duplicate entry in list)
- Department Name
- Department of Oncology
- Principal Investigator Name
- Gunhild von Amsberg
- Principal Investigator Email
- g.von-amsberg@uke.de
- Contact Person Name
- Gunhild von Amsberg
- Contact Person Email
- g.von-amsberg@uke.de
Italy
- Earliest CTIS Part Ii Submission Date
- 28-01-2026
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 40
- Number Of Sites
- 7
- Number Of Participants
- 33
Sites
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Oncologia Medica 1
- Principal Investigator Name
- Fabio Calabrò
- Principal Investigator Email
- fabio.calabro@ifo.it
- Contact Person Name
- Fabio Calabrò
- Contact Person Email
- fabio.calabro@ifo.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Oncologia Medica 1U
- Principal Investigator Name
- Massimo Di Maio
- Principal Investigator Email
- massimo.dimaio@unito.it
- Contact Person Name
- Massimo Di Maio
- Contact Person Email
- massimo.dimaio@unito.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Lorenzo Antonuzzo
- Principal Investigator Email
- lorenzo.antonuzzo@unifi.it
- Contact Person Name
- Lorenzo Antonuzzo
- Contact Person Email
- lorenzo.antonuzzo@unifi.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Oncologia Medica Urogenitale e Cervico Facciale
- Principal Investigator Name
- Franco Nolè
- Principal Investigator Email
- franconole.studiclinici@ieo.it
- Contact Person Name
- Franco Nolè
- Contact Person Email
- franconole.studiclinici@ieo.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Unità di Oncologia Medica
- Principal Investigator Name
- Andrea Necchi
- Principal Investigator Email
- necchi.andrea@hsr.it
- Contact Person Name
- Andrea Necchi
- Contact Person Email
- necchi.andrea@hsr.it
- Site Name
- Azienda Sanitaria Locale Napoli 2 Nord
- Department Name
- Oncologia
- Principal Investigator Name
- Gaetano Facchini
- Principal Investigator Email
- gaetano.facchini@aslnapoli2nord.it
- Contact Person Name
- Gaetano Facchini
- Contact Person Email
- gaetano.facchini@aslnapoli2nord.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l. (duplicate entry in list)
- Department Name
- Oncologia Medica Urogenitale e Cervico Facciale
- Principal Investigator Name
- Franco Nolè
- Principal Investigator Email
- franconole.studiclinici@ieo.it
- Contact Person Name
- Franco Nolè
- Contact Person Email
- franconole.studiclinici@ieo.it
Spain
- Earliest CTIS Part Ii Submission Date
- 20-02-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 69
- Number Of Sites
- 8
- Number Of Participants
- 42
Sites
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Oncology
- Principal Investigator Name
- Julio Lambea
- Principal Investigator Email
- juliolambea@yahoo.es
- Contact Person Name
- Julio Lambea
- Contact Person Email
- juliolambea@yahoo.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncology
- Principal Investigator Name
- Alberto Torres-Zurita
- Principal Investigator Email
- albertotorreszurita@gmail.com
- Contact Person Name
- Alberto Torres-Zurita
- Contact Person Email
- albertotorreszurita@gmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Oncology
- Principal Investigator Name
- María Ochoa de Olza Amat
- Principal Investigator Email
- maochoa@iconcologia.net
- Contact Person Name
- María Ochoa de Olza Amat
- Contact Person Email
- maochoa@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Elena Castro
- Principal Investigator Email
- ecastro.imas12@h12o.es
- Contact Person Name
- Elena Castro
- Contact Person Email
- ecastro.imas12@h12o.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Teresa Alonso
- Principal Investigator Email
- talonsogordoa@gmail.com
- Contact Person Name
- Teresa Alonso
- Contact Person Email
- talonsogordoa@gmail.com
- Site Name
- Consorcio Hospital General Universitario De Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Cristina Caballero
- Principal Investigator Email
- caballero_cri@gva.es
- Contact Person Name
- Cristina Caballero
- Contact Person Email
- caballero_cri@gva.es
- Site Name
- Hospital General Universitario Morales Meseguer
- Department Name
- Oncology
- Principal Investigator Name
- Marta Zafra
- Principal Investigator Email
- marta.zafra@carm.es
- Contact Person Name
- Marta Zafra
- Contact Person Email
- marta.zafra@carm.es
- Site Name
- Hospital Clinico Universitario Lozano Blesa (duplicate entry in list)
- Department Name
- Oncology
- Principal Investigator Name
- Julio Lambea
- Principal Investigator Email
- juliolambea@yahoo.es
- Contact Person Name
- Julio Lambea
- Contact Person Email
- juliolambea@yahoo.es
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Bioclinica Inc.
- Responsibilities
- Central Imaging
- Name
- 4g Clinical LLC
- Name
- Labcorp Central Laboratory Services LP
Third parties
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA vendor","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"Providing ancillare supplies","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- JNJ-78278343
- Active Substance
- JNJ-78278343
- Modality
- Bispecific antibody
- Routes Of Administration
- SOLUTION FOR INJECTION/INFUSION (intravenous infusion)
- Route
- Intravenous (infusion)
- Authorisation Status
- Not authorised
- Investigational Product Name
- Docetaxel (Docetaxel AqVida 20 mg/ml concentrate for infusion)
- Active Substance
- Docetaxel
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE (solution for infusion)
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- Prednisone (Prednison acis 5 mg)
- Active Substance
- Prednisone
- Modality
- Small molecule
- Routes Of Administration
- ORAL (tablets)
- Route
- Oral
- Authorisation Status
- Authorised
- Combination Treatment
- Yes
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