A Study of JNJ-78278343 Compared to Placebo for Patients with Advanced Prostate Cancer That No Longer Responds to Hormone Treatment

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What is this study about?

This study is looking at metastatic castration-resistant prostate cancer, which is a form of prostate cancer that has spread to other parts of the body and no longer responds to treatments that lower testosterone levels. The study will test a medication called JNJ-78278343, which is given as a solution through a needle into a vein. Some people in the study will receive this medication while others will receive placebo. All participants will also continue to receive their usual supportive care during the study.

The purpose of this study is to find out if JNJ-78278343 combined with usual care can help people live longer compared to placebo combined with usual care. The medication works by redirecting certain immune cells in the body to target a specific protein found on prostate cancer cells. People joining this study will have already tried several other treatments for their cancer, including hormone therapies, chemotherapy drugs called taxanes, and possibly other specialized treatments depending on what was available to them and what their doctors recommended.

During the study, participants will receive either the study medication or placebo through an infusion into their vein. They will continue their hormone therapy throughout the treatment period. The study will monitor how long participants live and track their overall health. People in the study should have cancer that has spread to bones or lymph nodes but not to major organs like the liver or lungs. They need to be well enough to carry out daily activities with some limitations but not be completely confined to bed or a chair.

1 Treatment assignment

Upon joining the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures fair distribution of participants.

One group will receive JNJ-78278343 (also called pasritamig), which is a medication that helps immune cells target cancer cells. The other group will receive placebo, which is an inactive substance that looks like the actual medication but contains no active treatment.

Neither you nor your doctor will know which treatment you are receiving. This is called a double-blind study design.

Both groups will also receive best supportive care, which includes standard treatments to manage symptoms and maintain quality of life.

2 Continuation of hormone therapy

You must continue your ongoing hormone therapy throughout the entire treatment period.

If you have had surgical removal of the testicles, no additional hormone therapy is needed.

If you have not had this surgery, you will continue receiving medications that suppress testosterone production. These are called GnRH analogs and may be either agonists or antagonists.

This hormone therapy must be maintained during all phases of the study treatment.

3 Study medication administration

You will receive either JNJ-78278343 or placebo through an infusion into your vein.

The medication is prepared as a solution for infusion, which means it will be delivered directly into your bloodstream over a period of time.

The specific dosage, frequency of administration, and duration of each infusion session will be determined by the study protocol and communicated to you by the medical staff.

The treatment will continue according to the schedule established in the study design.

4 Regular monitoring and assessments

Throughout the study, you will undergo regular monitoring to assess how the treatment is affecting you and your condition.

Blood tests will be performed to check various health indicators, including blood cell counts, kidney function, and liver function.

Your PSA level (a protein produced by the prostate that can indicate cancer activity) will be measured regularly.

Your overall health status and ability to perform daily activities will be assessed using the ECOG performance status scale, which ranges from 0 (fully active) to 5.

Any side effects or changes in your health will be recorded and evaluated.

5 Ongoing treatment phase

You will continue receiving the assigned study medication along with best supportive care.

The treatment will continue as long as it is considered beneficial and you do not experience unacceptable side effects.

Your medical team will monitor your response to treatment and overall survival, which is the main measure of how well the treatment works.

The study is expected to continue until May 2029, though your individual participation may be shorter or longer depending on your response to treatment and overall health.

Who Can Join the Study?

  • You must have prostate cancer that has been confirmed by examining tissue under a microscope, showing a type called adenocarcinoma. Certain other types of prostate cancer are not allowed in this study.
  • Your cancer must have spread to other parts of your body, such as bones or lymph nodes (small bean-shaped organs that are part of your immune system), and the cancer must continue to grow even though you are receiving treatment to lower male hormones.
  • Your PSA level (a protein in your blood that can indicate prostate cancer activity) must be at least 2 nanograms per milliliter at the time of screening.
  • Your doctor must believe that the best next treatment option for you is to join a clinical trial.
  • You must have already received all the standard treatments that could help you live longer and that you were able to receive. These treatments include: at least one type of hormone therapy for prostate cancer and you should not benefit from trying another similar hormone therapy; at least two rounds of chemotherapy using drugs called taxanes, or only one round if a second round is not available or your doctor thinks it would not be safe for you; treatment with a radioactive drug that targets prostate cancer cells, unless this treatment is not available or your doctor thinks it is not right for you; and treatment with a drug called a PARPi if you have a specific genetic change called a BRCA mutation and this treatment is available.
  • You must have had surgery to remove your testicles or be receiving ongoing treatment with medications that lower male hormones, and you must continue this treatment during the study.
  • Your overall health and ability to carry out daily activities must be good enough, rated on a scale where 0 means you are fully active and 2 means you can care for yourself but cannot work.
  • Your kidneys must be working well enough, with a measurement called eGFR (a test that shows how well your kidneys filter waste) of at least 30 milliliters per minute. If you have a blockage in your urinary system, it must be treated before joining the study.
  • Your liver must be working well enough, with certain blood tests showing: ALT and AST (enzymes that indicate liver health) no more than 5 times the upper normal limit, and bilirubin (a substance that shows how well your liver processes waste) no more than 3 times the upper normal limit.
  • Your blood counts must be adequate, including: white blood cells (cells that fight infection) at least 1.0 times 10 to the ninth power per liter; hemoglobin (the part of blood that carries oxygen) at least 8.0 grams per deciliter; and platelets (cells that help blood clot) at least 75 times 10 to the ninth power per liter. You cannot have received blood transfusions or medications to boost blood counts within 28 days before joining the study.
  • You must be male, as this study is only for men.

Who Cannot Join the Study?

  • Women cannot participate in this study
  • Children and teenagers under 18 years of age cannot participate in this study
  • People who do not have metastatic castration-resistant prostate cancer, which means prostate cancer that has spread to other parts of the body and no longer responds to treatments that lower testosterone levels

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
IRCCS Humanitas Research Hospital Rozzano Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
University Hospital Maastricht Maastricht The Netherlands
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Hospital Jerez de la Frontera Jerez De La Frontera Spain
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Klinikum Nuernberg Nürnberg Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
Isala Klinieken Stichting Zwolle The Netherlands
Hospital Universitario 12 De Octubre Madrid Spain
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Tergooiziekenhuizen Hilversum The Netherlands
Az Maria Middelares Gent Gent Belgium
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o. Warsaw Poland
ARNAS Civico Di Cristina Benfratelli Palermo Italy
Istituto Oncologico Veneto Padua Italy
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
In Vivo Sp. z o.o. Bydgoszcz Poland
Reinier de Graaf Groep Delft The Netherlands
CHC MontLegia Liege Belgium
CHU Helora La Louviere Belgium
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Spaarne Gasthuis Hoofddorp The Netherlands
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium
Urologicum Duisburg Duisburg Germany
Cavxmwipw Uccykbmogsqhcw Szhlraizi Woluwe-Saint-Lambert Belgium
Cbmnfz Ldhr Bnqjid Lyon France
Ujqjlwqaft Miaxmjf Cumkgo Hmstouafsiqirlarb Hamburg Germany
Udrnmzttpjgodqcrwztmf Eyuph Adp Essen Germany
Sfxrmkfnq Mghjgpe Zzfudlvdyg Groningen The Netherlands
Ughsiqecmggfliuunjjbx Dztipmthgpz App Duesseldorf Germany
Extibxc Uptcfszwsuvr Mbukpdh Cthdgwc Rytsxwexf (xjnyswu Mhf Rotterdam The Netherlands
Aenfxdm Ojgsgupyrrl Uuvfpspfjuxce Cvduecebcpzn Ddcch Sebmfc E Dznif Scbfxxs De Tsryad Turin Italy
Ugvokxquqobmzgzjrxclc Miyzingv Aky Munster Germany
Asloozh Oujbgzujyxs Ueopfpretoeaj Ojajrbhk Risfidd Foggia Italy
Nygdbcqb Iocdfnql Oinpwkmhv Ibo Meehd Sgxtovoiwqkjyrgejpwkugmcnyxh Ibfdsika Bydubowd Cracow Poland
Gpmfjc Hqgynvazsev Ubsigtbhrprxh Pkwoc Pcxkzbshgdc Ex Nukacmjmtdoo Paris France
Hfpxbkgs Vgoa dzdhjfdk Barcelona Spain
Codtho Ockvl Lnnrzfk Lille France
Hzpehwsu Ukhairjesnonwz Sqfnrpaqyr &zzfeng Hjikuta df Hwoezjycgqs STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
20.11.2025
France France
Recruiting
20.11.2025
Germany Germany
Recruiting
20.11.2025
Italy Italy
Recruiting
20.11.2025
Poland Poland
Recruiting
20.11.2025
Spain Spain
Recruiting
20.11.2025
The Netherlands The Netherlands
Recruiting
20.11.2025

Trial locations

Pasritamig is a medication being tested in this clinical trial. It is a type of treatment that helps direct the body’s immune system cells (called T-cells) to find and attack prostate cancer cells. Specifically, it works by targeting a protein called human kallikrein 2, which is found on prostate cancer cells. This medication is given along with best supportive care to patients with metastatic castration-resistant prostate cancer, which is an advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone treatments that lower testosterone.

Metastatic Castration-resistant Prostate Cancer – This is an advanced form of prostate cancer that has spread beyond the prostate gland to other parts of the body. The disease continues to grow and progress even when the level of testosterone in the body has been reduced to very low amounts through medication or surgery. In this condition, cancer cells have developed the ability to survive and multiply without needing normal levels of male hormones. The cancer may spread to bones, lymph nodes, or other organs throughout the body. Patients with this condition have typically already received treatments to lower testosterone levels, but the cancer has adapted and continues to advance. This represents a later stage in the progression of prostate cancer where the disease has become resistant to standard hormone-based treatments.

Trial ID:
2025-520927-26-00
Protocol code:
78278343PCR3001
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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

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  • A study evaluating the efficacy and safety of inavolisib and enzalutamide in patients with metastatic castration-resistant prostate cancer

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