Study of Pembrolizumab and Enzalutamide 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 (mCRPC). This is a form of prostate cancer that continues to grow and spread even when the amount of male hormones in the body is reduced to very low levels. The study is testing a combination of two treatments: Pembrolizumab, also known by its code name MK-3475, and Enzalutamide. Pembrolizumab is a medication that helps the immune system fight cancer, while Enzalutamide is used to block the effects of male hormones that can promote cancer growth. The trial will compare the effects of these two drugs together against a combination of a placebo and Enzalutamide.

The purpose of the study is to see if the combination of Pembrolizumab and Enzalutamide can help patients live longer and slow down the progression of the cancer compared to the placebo and Enzalutamide. Participants in the study will receive either the combination of Pembrolizumab and Enzalutamide or the placebo and Enzalutamide. The study will monitor the participants over a period to assess their overall survival and the time it takes for the cancer to progress as seen on medical imaging tests.

Throughout the study, participants will receive regular check-ups and assessments to monitor their health and the effects of the treatment. The study aims to provide valuable information on the effectiveness of combining Pembrolizumab with Enzalutamide in treating this challenging form of prostate cancer. The trial is expected to continue until 2025, providing insights that could lead to improved treatment options for patients with mCRPC.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of pembrolizumab and enzalutamide, while the other group will receive a placebo with enzalutamide. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

2 medication administration

If you are in the group receiving pembrolizumab, it will be administered as an intravenous infusion. This means the medication will be given through a vein in your arm. The dosage is 25 mg/mL, and the frequency and duration will be determined by the study team.

You will also take enzalutamide orally, which means you will swallow the medication in pill form. The dosage and frequency will be provided by the study team.

3 monitoring and assessments

Throughout the study, you will undergo regular monitoring and assessments to evaluate your health and the effects of the treatment. This may include blood tests, imaging scans like CT or MRI, and other evaluations as needed.

The study aims to compare overall survival and progression-free survival between the two groups. Progression-free survival refers to the length of time during and after treatment that the cancer does not get worse.

4 completion of the study

The study is expected to continue until February 28, 2025. Your participation may last until the study ends or until you and the study team decide it is best for you to stop.

After completing the study, you may have follow-up visits to monitor your health and gather additional information about the long-term effects of the treatment.

Who Can Join the Study?

  • Must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of prostate cancer, without any small cell cancer features.
  • Prostate cancer must have progressed while on androgen deprivation therapy (a treatment to lower male hormones) or after surgical removal of the testicles, within 6 months before joining the study.
  • Must have current evidence of metastatic disease, meaning the cancer has spread to other parts of the body, shown by bone lesions on a bone scan or soft tissue disease on a CT or MRI scan.
  • Must be undergoing ongoing androgen deprivation therapy with serum testosterone levels less than 50 ng/dL (a measure of male hormone levels).
  • Only male participants are eligible for this study.

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 in this study.
  • 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

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Jean Perrin Clermont Ferrand France
Medical Center Haaglanden Hague The Netherlands
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
Universitaetsmedizin Goettingen Goettingen Germany
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Hospital Universitario Hm Sanchinarro Madrid Spain

Other Sites

Site Name City Country Status
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Amphia Hospital Breda The Netherlands
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Stichting Radboud University Medical Center Nijmegen The Netherlands
Centre Hospitalier De Saint-Quentin Saint Quentin France
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Klinikum Nuernberg Nürnberg Germany
Orszagos Onkologiai Intezet Budapest Hungary
ASL Napoli 2 Nord – Ospedale Santa Maria delle Grazie Pozzuoli Italy
Virgen del Rocío University Hospital Sevilla Spain
Centre Hospitalier Universitaire d’Orléans Orléans France
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Hospital Foch Suresnes France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Barmherzige Brueder Trier gGmbH Trier Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Charite Research Organisation GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
University Hospital Limerick Limerick Ireland
Tergooiziekenhuizen Hilversum The Netherlands
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Hospital San Pedro De Alcantara Caceres Spain
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Institut Sainte Catherine Avignon France
Immobiliere De Nancy Nancy France
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Centre Hospitalier De Valenciennes Valenciennes France
MD Anderson Cancer Center Madrid Spain
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Centre Hospitalier Universitaire De Nantes Saint-Herblain France
Adelaide And Meath Hospital Dublin Ireland
Provita Centrum Medyczne Sp. z o.o. Tomaszow Mazowiecki Poland
Beaumont Hospital Dublin Ireland
Groupe Hospitalier Saint Vincent STRASBOURG, Alsace France
Hospital Universitario Virgen De La Victoria Malaga Spain
I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III Restauracja Rogatka Roman Karaszewski Konin Poland
Acdtmchbnl Ztekuujpds Mwymmmubja Maastricht The Netherlands
Pxyp Thpyz Hsqbullb Ushvzoewmcdm Sabadell Spain
Azfrkye Ojgtmaqkfcx Pzs Lnghyoujqeoczllpw Cyrclflbjf Catania Italy
Uddvosomyeoocdxrimwsv Muyvwmel Are Munster Germany
Gbmcvcijlcrwmvoet Vyhrltsrl Pgon Adxjhn Eokqkfot Opliex Kdegvv Gyor Hungary
Iqrtroxh Rsxuxqqp De Cyqtfw Dm Mvarlwieffg Montpellier France
Bypulzshawu Vxumrsdfp Ozrvzehwtlrv Kecskemet Hungary
Adrvtzprf Ufx Amsterdam The Netherlands
Barloemk Upangeckhv Hhqncgic Cfltos Besançon France
Azbikvq Upllk Syfcfhaqn Ltcykt Df Bmjzkvu Bologna Italy
Oimglgbhowzxdo Lsqu Gnfw Linz Austria
Ipnshrvz Clwzvr Dnmrykkvfzynduufn L'hospitalet De Llobregat Spain
Izrfsxdz Mjlrexmigd Mfuzvcatmb Paris France
Mvesckq Cpwjgz Hbsbxkdnp Dhwzffu Fduxqv Budapest Hungary

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
05.07.2019
Bulgaria Bulgaria
Not recruiting
05.07.2019
Czechia Czechia
Not recruiting
05.07.2019
France France
Not recruiting
05.07.2019
Germany Germany
Not recruiting
05.07.2019
Hungary Hungary
Not recruiting
05.07.2019
Ireland Ireland
Not recruiting
05.07.2019
Italy Italy
Not recruiting
05.07.2019
Poland Poland
Not recruiting
05.07.2019
Spain Spain
Not recruiting
05.07.2019
The Netherlands The Netherlands
Not recruiting
05.07.2019

Trial locations

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being tested to see if it can help improve survival in patients with a specific type of prostate cancer that has spread to other parts of the body and is resistant to standard hormone therapy.

Enzalutamide is a medication used to treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this trial, enzalutamide is used in combination with pembrolizumab to see if the two medications together can be more effective in treating prostate cancer than enzalutamide alone.

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread despite low levels of testosterone, which is typically achieved through medical or surgical castration. The disease is characterized by the cancer cells’ ability to thrive even when androgen levels are reduced to very low levels. It often spreads to bones, lymph nodes, and other parts of the body. As the cancer progresses, patients may experience symptoms such as bone pain, urinary issues, and fatigue. The progression of the disease is monitored through imaging studies and prostate-specific antigen (PSA) levels. Over time, the cancer may become more aggressive and resistant to standard therapies.

Trial ID:
2022-500785-10-00
Protocol code:
MK-3475-641
NCT ID:
NCT03834493
Trial Phase:
Therapeutic confirmatory (Phase III)

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