A study of JNJ-78278343 and docetaxel compared to docetaxel and prednisone in patients with metastatic castration-resistant prostate cancer

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What is this study about?

This study focuses on individuals with Metastatic Castration-resistant Prostate Cancer, a type of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy. The purpose of the study is to compare the effectiveness of a new combination treatment against a standard treatment option.

Participants in the study will receive different combinations of medications. One group will be given JNJ-78278343, also known as pasritamig, which is a type of agent designed to redirect T-cells, which are cells in the immune system that help fight disease, to target specific markers on cancer cells. This is administered alongside docetaxel, a chemotherapy medication given through an intravenous infusion, which is a liquid delivered directly into a vein. Another group will receive only docetaxel. Some participants may also take prednisone, a type of steroid medication, as part of their treatment regimen.

Who Can Join the Study?

You must be a male.
You must be between the ages of 18 and 50.
Your cancer must be showing signs of growing or spreading, which means having at least one of the following:
A PSA level (a protein used to track prostate cancer) of 2 or higher that has increased during two separate tests taken at least one week apart.
New signs of cancer or lesions (abnormal areas of tissue) appearing in your lymph nodes, bones, or viscera (internal organs like the liver or lungs) as seen on medical scans.
You must have already tried and progressed on at least one ARPI (a type of hormone therapy that stops cancer growth) but must not have used more than two different types of these drugs.
You must have stopped taking ARPI medication before joining the study.
Your hemoglobin (a protein in red blood cells that carries oxygen) must be at least 9.0 g/dL.
Your neutrophils (a type of white blood cell that helps fight infection) must be at least 1.5 x 10^9/L.
Your platelets (cells that help your blood clot to stop bleeding) must be at least 100 x 10^9/L.
You must not have received a blood transfusion or used growth factors (medicines that increase blood cell counts) within 14 days before starting the study.

Who Cannot Join the Study?

You cannot participate if you have already received cytotoxic chemotherapy, which is a type of strong medicine used to kill fast-growing cancer cells, for your prostate cancer.
You are not eligible if you have previously used CD3 redirector therapies, radiopharmaceutical agents (medicines that use radiation to treat cancer), or immunotherapy agents (treatments that help your immune system fight cancer) for prostate cancer.
You cannot join the study if you have taken PARP inhibitors, which are a specific type of targeted medicine used to treat certain cancers, unless they were used specifically for BRCA1/2 mutations.
You are excluded if you have already used any other investigational agent, which refers to a drug or treatment that is still being studied and is not yet widely available.
If you have known BRCA 1/2 mutations (changes in your genes that can increase cancer risk), you cannot participate unless you have already tried a PARP inhibitor and it was either not available to you or was not safe for you to use.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Centre Jean Perrin	Clermont Ferrand	France
Technische Universitaet Dresden	Dresden	Germany
Algemeen Stedelijk Ziekenhuis Campus Aalst	Aalst	Belgium

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Nimes	Nimes	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital General Universitario Morales Meseguer	Murcia	Spain
Az Maria Middelares Gent	Gent	Belgium
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR	Nuertingen	Germany
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Urologicum Duisburg	Duisburg	Germany
Azienda Sanitaria Locale Napoli 2 Nord	Frattamaggiore	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital General Universitario De Valencia	Valencia	Spain
Gasthuiszusters Antwerpen	Antwerp	Belgium
CHC MontLegia	Liege	Belgium
CHU Helora	La Louviere	Belgium
Hopital Beaujon	Clichy	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Cqdsze Lesz Bdygxu	Lyon	France
Umzdqyfpmv Mpkxfdu Cuqhgk Hiefjmridjurcbqod	Hamburg	Germany
Uspceawujdpqkrwuaylcx Edwpm Avp	Essen	Germany
Iczejh Isqfjfks Frmuxmusvelhk Orrnexrugjd	Rome	Italy
Aytgrpu Oxremvskjyk Umxjmxkxmvnzr Cafkofkvemwn Dcbnd Sllpzv E Dcudj Sgnoqpw Dp Tcwbwm	Turin	Italy
Hrtzlcet Ucdltchpkcgfy Hwducxme Txqwh y Pdjnsw Imfyfyxm Ckghov disttulfiokybpwuf (taua	Badalona	Spain
Catxkg Ovlcf Laktujy	Lille	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	07.04.2026
France	Recruiting	07.04.2026
Germany	Recruiting	07.04.2026
Italy	Recruiting	07.04.2026
Spain	Recruiting	07.04.2026

Trial locations

Investigated drugs:

Docetaxel is a type of chemotherapy medicine that is given through a vein. It works by stopping cancer cells from growing and dividing.

JNJ-78278343 is an experimental medicine being tested in this study. It is designed to help the body’s own immune system, specifically T-cells, find and attack cancer cells that have a certain protein on their surface.

Prednisone is a steroid medication that is taken by mouth. In this study, it is used as a comparison treatment alongside the chemotherapy.

Metastatic Castration-resistant Prostate Cancer – This is an advanced form of prostate cancer that has spread to other parts of the body. It occurs when the cancer continues to grow even though hormone therapy has lowered testosterone levels to very low amounts. The disease involves cancer cells that no longer respond to the standard methods of reducing male hormones. As the condition progresses, the cancer cells can multiply and move into bones or other organs. This stage represents a more advanced phase of the disease where the cancer becomes less sensitive to typical hormonal controls.

Trial ID:

2025-522713-29-00

Protocol code:

78278343PCR3003

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study of JNJ-78278343 and docetaxel compared to docetaxel and prednisone in patients with metastatic castration-resistant prostate cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?