A Study of Mevrometostat and Enzalutamide for Men with Metastatic Castration-Sensitive Prostate Cancer Who Have Not Received Hormonal Therapy or Chemotherapy

3 1 1

What is this study about?

This study involves men with metastatic castration-sensitive prostate cancer, which is a type of prostate cancer that has spread to other parts of the body but still responds to treatments that lower testosterone levels. The study will test a combination of two medications: mevrometostat, which is also known by its code name PF-06821497, and enzalutamide, which is already used to treat prostate cancer. Some participants will receive mevrometostat together with enzalutamide, while others will receive placebo together with enzalutamide. The purpose of the study is to find out if adding mevrometostat to enzalutamide can help delay the worsening of the cancer compared to using enzalutamide with placebo.

During the study, participants will take their assigned medications by mouth as tablets or capsules. They will continue their ongoing hormone therapy that lowers testosterone levels throughout the study. The study will track how long it takes for the cancer to get worse by using imaging scans, which are special pictures of the inside of the body taken with machines. The study team will also monitor various aspects of health, including blood tests to measure a substance called prostate-specific antigen, pain levels, quality of life, and any side effects that may occur. Participants will attend regular visits where doctors will perform examinations and tests to assess how the treatment is working and how participants are feeling.

The study will also look at other important measures such as how long participants live, whether tumors shrink in response to treatment, how long any tumor shrinkage lasts, and how long it takes before additional cancer treatments are needed. Doctors will carefully monitor for any unwanted effects of the medications and will check participants’ overall well-being through questionnaires about pain, tiredness, and daily functioning. Blood samples will be taken at certain times to measure the levels of mevrometostat in the body and to examine genetic material from cancer cells that may be circulating in the blood.

1 Treatment initiation

Your treatment will begin on Day 1 after completing all required tests and procedures.

You will be randomly assigned to receive either the study medicine mevrometostat combined with enzalutamide, or a placebo combined with enzalutamide. Neither you nor your doctor will know which treatment you receive.

You must continue your androgen deprivation therapy (a treatment that lowers male hormones) throughout the entire study. This therapy must have been started before entering the trial.

2 Daily medication

You will take enzalutamide capsules by mouth every day. The dose is 40 mg soft capsules.

You will also take mevrometostat tablets or placebo tablets by mouth every day. These tablets are taken orally.

You must take your medications as instructed throughout the treatment period.

If you previously received certain hormone treatments such as estrogens, cyproterone acetate, or first-generation antiandrogens, these must be stopped before starting the trial medication.

3 Regular study visits

You will attend regular study visits at the trial site.

During these visits, blood samples will be taken before you take your daily dose to measure the levels of the study medicine in your blood.

Blood samples will also be taken after you take your dose at selected visits.

Blood tests will be performed to measure your prostate-specific antigen levels, which is a marker used to monitor prostate cancer.

Additional blood tests will be conducted to check for circulating tumor DNA, which are cancer-related genetic materials in your blood.

4 Imaging scans

You will undergo imaging scans at scheduled intervals to assess how your cancer is responding to treatment.

These scans may include CT scans or MRI scans to check for soft tissue or organ involvement.

You will also have bone scans to monitor any cancer spread to your bones.

The scans will be reviewed by independent experts who do not know which treatment you are receiving.

5 Safety monitoring

Your health will be closely monitored throughout the study for any side effects or adverse reactions.

Electrocardiograms (heart rhythm tests) will be performed at selected visits to monitor your heart function.

Laboratory tests will be conducted regularly to check your blood counts, liver function, kidney function, and other health indicators.

Any side effects will be assessed and graded according to standard medical criteria.

6 Quality of life assessments

You will be asked to complete questionnaires about your symptoms and quality of life at regular intervals.

These questionnaires will ask about pain levels using the Brief Pain Inventory.

You will complete questions about fatigue using the Brief Fatigue Inventory.

Additional questionnaires will assess your overall well-being, daily functioning, and prostate cancer-specific symptoms.

You will also complete a general health status questionnaire.

7 Ongoing treatment period

You will continue taking the study medications daily as long as your cancer does not progress and you do not experience unacceptable side effects.

Your doctor will monitor for signs of disease progression through regular scans, blood tests, and physical examinations.

The study will track the time until your cancer shows signs of progression, until it becomes resistant to hormone therapy, or until you require additional cancer treatment.

8 End of treatment

Your treatment in the study will end if your cancer progresses, if you experience unacceptable side effects, or if you decide to stop participating.

If your disease progresses or becomes resistant to hormone therapy, your doctor will discuss other treatment options with you.

The study team will continue to collect information about your health and survival status even after you stop taking the study medication.

Who Can Join the Study?

    To be able to join this clinical trial, you must meet all of these requirements:

  • You must be a male participant who is 18 years of age or older at the time of screening
  • You must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of cancer that starts in the gland cells of the prostate. This diagnosis must be confirmed through a tissue sample examined under a microscope. The cancer should not have small cell features, although other minor cell types are allowed if adenocarcinoma is the main type
  • You must have metastatic prostate cancer, which means the cancer has spread from the prostate to other parts of your body. This spread must be shown on imaging tests such as a bone scan showing cancer in the bones, or a CT scan or MRI scan showing cancer in soft tissues or organs
  • Any side effects from previous treatments must have improved to either your normal baseline level or to a mild level, unless your doctor determines that remaining side effects do not pose a safety risk
  • You cannot have received certain types of prostate cancer treatments before joining the study, with some exceptions. You cannot have had chemotherapy or specific hormone-blocking medications. However, you may have had androgen deprivation therapy or ADT, which is a treatment that lowers male hormone levels, for up to 3 months before joining, and you must continue this treatment during the study. You may have used certain older hormone medications until joining the study, but these must be stopped before you start. You may have had one session of radiation therapy or surgery to relieve symptoms, as long as it was completed at least 2 weeks before joining the study
  • You must have an ECOG performance status of 0 or 1, which is a measure of how well you can perform daily activities. A score of 0 means you are fully active, and a score of 1 means you have some restrictions but can still do light work

Who Cannot Join the Study?

  • Women cannot participate in this study because it is only for male patients
  • Children and teenagers cannot participate in this study as it is designed for adults
  • Patients who are part of vulnerable populations, which means groups of people who need special protection in medical research, cannot participate

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centre Antoine Lacassagne Nice France
Institut Jules Bordet Anderlecht Belgium
Medical Centre Futuremeds EOOD Plovdiv Bulgaria
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Tergooiziekenhuizen Hilversum The Netherlands
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
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
AZ Sint-Lucas & Volkskliniek Gent Belgium
Urocentrum Praha s.r.o. Prague Czechia
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Vychodoslovensky Onkologicky Ustav a.s. Kosice Slovakia
Oulu University Hospital Oulu Finland
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte Bulgaria
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Manresa Spain
Clinique Pasteur Lanroze Brest France
Institut Godinot Reims France
Privatna Urologicka Ambulancia s.r.o. Trencin Slovakia
Vaasa Central Hospital Vaasa Finland
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Zachodniopomorskie Centrum Onkologii Szczecin Poland
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universita’ Degli Studi Di Verona Verona Italy
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Narodny Onkologicky Ustav Bratislava Slovakia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Turku University Hospital Turku Finland
Hospital General Universitario De Valencia Valencia Spain
Jessa Ziekenhuis Hasselt Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Centre Hospitalier De La Cote Basque Bayonne France
Medikard s.r.o. Presov Slovakia
Reinier de Graaf Groep Delft The Netherlands
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
University Hospital Olomouc Olomouc Czechia
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Pirkanmaan hyvinvointialue Tampere Finland
Hospital Alvaro Cunqueiro Vigo Spain
Netherlands Cancer Institute Amsterdam The Netherlands
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Fakultni Thomayerova nemocnice Prague Czechia
Hospital Universitario Virgen De La Victoria Malaga Spain
Metropolitan Hospital Athens Greece
Azorg Aalst Belgium
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
EMC Instytut Medyczny S.A. Poznan Poland
Urologie Neandertal Mettmann Germany
Cxmypd Lpag Bmxfvz Lyon France
Uialurnwkh Mjktjlz Cwamhx Hnplmdxhwqjxqabol Hamburg Germany
Injaaw Iviuxjte Fxklmbpmkiygu Oahuzgutabl Rome Italy
Ibuvnnyq Cdbsmk Dsnxuflahcjscvgkl L'hospitalet De Llobregat Spain
Syourlpo Pmjqknsim Sqi z ocau Gdynia Poland
Dbpadxom Oq Helsinki Finland
Lwrsi Gfylgeo Hmygzjoi On Alsgru Athens Greece
Fldyashn nlmuljvoo Muacd a Hljfxrj Prague Czechia
Ijksdpzr Rinasvklm Pzu Lc Skenzp Daj Tsmpdg Deeo Ajeahwg Iwzf Siisjd Meldola Italy
Ufumxsbjgdmoqyhjsggtf Dmjihelopnn Aft Duesseldorf Germany
Bqhssudw Utikktaknd Hdwvjjus Cvkupm Besançon France
Hvimukgv Ustyzxivyi Cxzkkub Hljuqqhx Helsinki Finland
Uzfkbgjuidhzkbaslvwpj Mzfhlbew Akz Munster Germany
Axouwy Mocfigg Cfdmcn Sbvx Thessaloniki Greece
Ahnlfrk Uuftk Sgebmckaf Liobvl Dq Bwwwekd Bologna Italy
Pvwbtez Cuzvzx Sus z otcu Wroclaw Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
30.08.2025
Bulgaria Bulgaria
Recruiting
30.08.2025
Czechia Czechia
Recruiting
30.08.2025
Finland Finland
Recruiting
30.08.2025
France France
Recruiting
30.08.2025
Germany Germany
Recruiting
30.08.2025
Greece Greece
Recruiting
30.08.2025
Italy Italy
Recruiting
30.08.2025
Poland Poland
Recruiting
30.08.2025
Slovakia Slovakia
Recruiting
30.08.2025
Spain Spain
Recruiting
30.08.2025
The Netherlands The Netherlands
Recruiting
30.08.2025

Trial locations

Mevrometostat is an investigational medication being studied in this trial. It is given in combination with enzalutamide to see if it can help slow down the progression of prostate cancer that has spread to other parts of the body. This medication works by blocking certain proteins that cancer cells need to grow.

Enzalutamide is a medication used to treat prostate cancer. It works by blocking the effects of male hormones like testosterone that can help prostate cancer cells grow. In this trial, it is being given to all participants, either alone or together with mevrometostat.

Placebo is an inactive substance that looks like the study medication but contains no active ingredients. Some participants will receive placebo instead of mevrometostat, along with enzalutamide, to help researchers compare the effects of the actual medication.

Investigated diseases:

Metastatic Castration-Sensitive Prostate Cancer – This is a type of prostate cancer that has spread beyond the prostate gland to other parts of the body, such as bones or distant lymph nodes. The term castration-sensitive means that the cancer still responds to treatments that lower testosterone levels in the body. Testosterone is a male hormone that can fuel the growth of prostate cancer cells. In this stage, the cancer cells continue to depend on male hormones to grow and multiply. As the disease progresses, cancer cells spread through the bloodstream or lymphatic system to distant sites. Over time, this type of cancer may eventually stop responding to hormone-lowering treatments and progress to a more advanced form called castration-resistant prostate cancer.

Trial ID:
2024-519369-24-00
Protocol code:
C2321008
NCT ID:
NCT07028853
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Docetaxel and Apalutamide in Patients with Metastatic Hormone-Sensitive Prostate Cancer Who Did Not Have a Deep PSA Response After Initial Apalutamide Treatment

    Recruiting

    3 1 1 1
    Investigated drugs:
    France Germany Italy Portugal Spain
  • Study of ifinatamab deruxtecan alone or in combination with other treatments for patients with metastatic castration-resistant prostate cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    France Germany Ireland Italy The Netherlands Poland +1