Study of Vobramitamab Duocarmazine and Prednisone for Patients with Metastatic Castration-Resistant Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as Metastatic Castration-resistant Prostate Cancer. This is a form of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. The study is testing a new treatment called Vobramitamab Duocarmazine, which is an antibody-drug conjugate. This means it is a special type of medicine that combines an antibody with a drug to target and kill cancer cells more effectively. The trial will also use a medication called Prednisone, which is a steroid that can help reduce inflammation and support the body during cancer treatment.

The purpose of the study is to evaluate how effective Vobramitamab Duocarmazine is at two different dose levels in treating this type of prostate cancer. Participants in the study will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will compare the effects of the two dose levels to see which one works better in slowing down the progression of the cancer. Some participants may also receive a placebo, which is a substance with no active medication, to help researchers understand the true effects of the treatment.

Throughout the study, participants will be monitored regularly to assess how the cancer is responding to the treatment. This will involve various tests and scans, such as MRI or computed tomography (CT), to check for changes in the cancer. The study aims to provide valuable information on the potential benefits and safety of Vobramitamab Duocarmazine for patients with this challenging form of prostate cancer. The trial is expected to continue for a period of time to gather enough data to make informed conclusions about the treatment’s effectiveness.

1 initial assessment

Upon joining the study, an initial assessment will be conducted. This includes confirming the diagnosis of metastatic castration-resistant prostate cancer and ensuring there are no signs of specific cell features that are not allowed in the study.

A review of recent imaging tests, such as MRI, CT, or bone scans, will be performed to confirm the presence of at least one metastatic lesion. These tests should have been completed within 28 days before starting the study treatment.

2 treatment initiation

The treatment phase begins with the administration of vobramitamab duocarmazine. This medication is given as an intravenous infusion, meaning it is delivered directly into a vein.

In addition to the infusion, prednisone tablets will be taken orally. The dosage and frequency of these medications will be specified by the study team.

3 ongoing treatment and monitoring

Throughout the study, regular monitoring will occur to assess the effectiveness of the treatment. This includes tracking the progression of the cancer using imaging tests and measuring specific markers in the blood.

Participants will be observed for any side effects or adverse reactions to the medications. Adjustments to the treatment plan may be made based on these observations.

4 completion of study

The study is expected to continue until September 2026. Participants will be informed about the end of their involvement in the study and any follow-up procedures that may be necessary.

Final assessments will be conducted to evaluate the overall outcomes of the treatment and its impact on the cancer.

Who Can Join the Study?

  • Must have a confirmed diagnosis of adenocarcinoma of the prostate. This means a specific type of prostate cancer that does not show certain rare features.
  • Must have at least one metastatic lesion. This is a cancer spot that has spread to other parts of the body, visible on an MRI, CT scan, or bone scan done within 28 days before starting the study treatment.
  • Must show tumor progression at the start of the study. This means the cancer is getting worse, as shown by a blood test called PSA or imaging tests.
  • Must have received one previous treatment called ARAT for prostate cancer. ARAT stands for Androgen Receptor Axis-Targeted therapy, which is a type of medication used to treat prostate cancer. A second short-term ARAT treatment is allowed if it was used to prepare for another treatment called lutetium-177.
  • Must provide a sample of the tumor tissue if the cancer has spread to internal organs. This sample can be from a previous biopsy or surgery.
  • Must be in an acceptable physical condition and have laboratory test results that are within a safe range.
  • Must be male.

Who Cannot Join the Study?

  • Patients who do not have Metastatic Castration-resistant Prostate Cancer cannot participate. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Only male patients can participate.
  • Patients who are part of a vulnerable population cannot participate. This means groups of people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Medical Concierge Centrum Medyczne Warsaw Poland

Verified Sites

Site Name City Country Status
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Institut Gustave Roussy Villejuif France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland

Other Sites

Site Name City Country Status
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Hospital Universitario Lucus Augusti Lugo Spain
Onko-Centrum Sp. z o.o. Lublin Poland
Grand Hopital De Charleroi Charleroi Belgium
Hospital Ruber Juan Bravo Madrid Spain
Istituto Oncologico Veneto Padua Italy
Centre Antoine Lacassagne Nice France
Nemocnice Na Homolce Prague Czechia
Virgen del Rocío University Hospital Sevilla Spain
Unite De Recherche Clinique HIA Begin Saint-Mande France
Lux Med Onkologia Sp. z o.o. Warsaw Poland
University Hospital Olomouc Olomouc Czechia
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Hospital Foch Suresnes France
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Az Maria Middelares Gent Gent Belgium
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Urologische Gemeinschaftspraxis Wesel Germany
Hopital De Libramont Libramont-Chevigny Belgium
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o. Warsaw Poland
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Provita Centrum Medyczne Sp. z o.o. Warsaw Poland
Pltl Tbdbt Hyxttzyv Uazvjhdgfkzi Sabadell Spain
Usiqyihoudmgifosjxeez Myomleta Adu Munster Germany
Cffxvzqy Vrrbaw Hgjci Cefmqn Cvwqunjisikh dm lv Sgccnj Le Mans France
Annqwxw Uxhl npj Syqccjhkfbp – Ohzeqnre dn Mrhiqn Mirano Italy
Ciyglnnrv Uhcnbfndalvqbk Shayiexkf Woluwe-Saint-Lambert Belgium
Ibbvjtfh Ramicjrc Dk Coxjxt Dm Mgffdohenps Montpellier France
Pwvhivgdpgb Lswofnts &tbtqfcsjycwmrqfzfxn Rnuum Kncxbtjdngc Konin Poland
Hpyootfn Dl Li Sabqx Cdqu I Sfha Pti Barcelona Spain
Itmcuz Iogdykez Fizbmclednxja Ofnznvbzncx Rome Italy
Ipvmiwzc Cueopb Ddsqifhcnrvfqsmky L'hospitalet De Llobregat Spain
Ijeptdod Mefcbmsxqx Mvizeoefzp Paris France
Hquhsfvh Umvalwaodnvwz Hpvrfzkj Tjnhf y Pxhnnw Ipyncfde Ctmasi dpsjemxirhecrhepr (rzro Badalona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.04.2023
Czechia Czechia
Not recruiting
01.04.2023
France France
Not recruiting
01.04.2023
Germany Germany
Not recruiting
01.04.2023
Italy Italy
Not recruiting
01.04.2023
Poland Poland
Not recruiting
01.04.2023
Spain Spain
Not recruiting
01.04.2023

Trial locations

Vobramitamab Duocarmazine is a medication being studied for its potential to treat prostate cancer that has spread to other parts of the body and is resistant to standard hormone therapy. This medication is designed to target and bind to specific proteins on the surface of cancer cells. Once attached, it delivers a toxic substance directly into the cancer cells, which may help to stop their growth or kill them. The goal of using this medication in the trial is to see if it can help slow down the progression of the cancer as observed through imaging tests. Participants in the trial receive this medication to evaluate its effectiveness and safety in managing their condition.

Metastatic Castration-resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread despite treatments that lower testosterone levels. It is characterized by the cancer’s ability to metastasize, or spread, to other parts of the body, such as bones and lymph nodes. The disease progresses as cancer cells become resistant to hormonal therapies that are typically used to control prostate cancer growth. Over time, the cancer may cause symptoms such as pain, urinary issues, and fatigue due to its spread and growth. The progression of the disease is often monitored through imaging tests and prostate-specific antigen (PSA) levels. As the cancer advances, it may lead to complications related to bone health and other systemic effects.

Trial ID:
2022-501078-20-00
Protocol code:
CP-MGC018-03
NCT ID:
NCT05551117
Trial Phase:
Therapeutic exploratory (Phase II)

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