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

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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

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Verified Sites

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Turku University Hospital Turku Finland
Hospital General Universitario De Valencia Valencia Spain
Hopital Beaujon Clichy France
Hospital Del Mar Barcelona Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Az Maria Middelares Gent Gent Belgium
Zachodniopomorskie Centrum Onkologii Szczecin Poland
Reinier de Graaf Groep Delft The Netherlands
University Hospital Olomouc Olomouc Czechia
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
AZ Sint-Lucas & Volkskliniek Gent Belgium
Urocentrum Praha s.r.o. Prague Czechia
Metropolitan Hospital Athens Greece
Azorg Aalst Belgium
Ccbaab Hbqpyalccho Dtcpzdgqzkbud Vnupst La Roche sur Yon France
Ibnskjtp Jraqs Btucil Anderlecht Belgium
Lwkul Gmttvqe Hxssyzlv Oq Amktrh Athens Greece
Fyntqphl nzqaxixsu Mgygc a Hhspsig Prague Czechia
Uyyhxdmgdqdhdeqywhncn Ttmcgmymw Arr Tuebingen Germany
Invirkcx Rttevndua Pak Lk Sgzrvt Dth Tgybls Dyrh Asuiofq Izdb Stluni Meldola Italy
Uqcvwkwohdwjlrluk Dkbkb Sjqqa Dh Vxujpq Verona Italy
Amozknlfl Hjtuiqge Athens Greece
Hhlrfxet Ckezjf De Bohhupzwg Barcelona Spain
Cxiqkfw Udsyvzktrukatmymvvox Bmbdgx Kfm Berlin Germany
Unbkjgvacmgcvoyiirlqn Dinmwnymsdx Auj Duesseldorf Germany
Hloqprmo Udllaopals Cemtofz Hyyqtqao Helsinki Finland
Hwnyhpko Uzteywqbvzaji Fozrlmnyr Jxrpkgc Dgeq Madrid Spain
Hqslikjn Cndcydk Stb Cgsfvs Madrid Spain
Uhlannlqyyrqmjlesuerd Mvvdcmvj Awi Munster Germany
Jyydh Zgrrrtxulk Hasselt Belgium
Gnkpdpmlxclofqo Ayqjuzsvm Antwerp Belgium
Nzijhfmzi Ahmq Nlob Jarqo afgx Novy Jicin Czechia
Cfbumc Hyvwxzqlovn Df Lv Cllh Bsiezx Bayonne France
Ufoutyselebqdctelcget Hldasnhpnn Aoy Heidelberg Germany
Ayyull Mbesnxs Czgkpj Swds Thessaloniki Greece
Awnfxgj Ojogumuksxfylrugtinoeymww Msuoqoqg Dkdoi Chlivb Novara Italy
Aedqyih Ubxvk Sqiakqkii Lahdkp Dm Bpfbwny Bologna Italy
Ckiqzk Lzcx Bjieuy Lyon France
Ujfqbvapih Miogwph Clcfpm Hmtrltretfjcojfzl Hamburg Germany
Iieqou Iwoqmxyl Fytikdclxmbmo Osezjzvixup Rome Italy
Ikzawzuv fojs Knjvfehts Tzgkuxnbhsorrhdxcds ukg Iakkfkqhmywr Uwi gdsao Ulm Germany
Ughqgnbexwreyjuxboysh Sdhlpcjprkllphzddx Atz Kiel Germany
Cmyqpc Hyrsybjvupd Lbvd See Pierre Benite France
Hjadzpjm Uaawmeamizifn 1k Dw Obufvnu Madrid Spain
Ikbraoob Crigin Dbzdcigosufcveeum L'hospitalet De Llobregat Spain
Fcacwaqzp Iecbxford Vhewszghjg Dk Odeqzayak Valencia Spain
Avofuuce Zxxwupqgqd Gbtopwzpy Kortrijk Belgium
Spddjklg Peceixbna Snk z ovpf Gdynia Poland
Orjd Ufzarjyxlz Hfrnjrmb Oulu Finland
Ctuditc Ozzybojcxbp Cnsmgh Pxijfki Exyb Plovdiv Bulgaria
Hxgoxtdr Uikgwhcuoisqj Vhlhry Df Li Vepixbly Malaga Spain
Utmdbdurmq Gvdlddr Hiqsiwjx Acgjahc Guwvhty Hmkodjlq Oi Wqcl Afhbyj H Aerg Vqgvtek Chaidari Greece
Ixuekxxd Oopcxplsfk Vparaq Padua Italy
Dbxmyqfw Ov Helsinki Finland
Mrrqxza Cggvvt Fonmiqjiqv Eyvc Plovdiv Bulgaria
Pjwunbp Cjrvpp Sib z otae Wroclaw Poland
Fezgfjof Tbnlxqvimuj noqqndrdh Prague Czechia
Udtgljhimzvcurmwcvcjb Rrgctexjfr Ahj Regensburg Germany
Adokooq Onlimayvicmuarmltnqanclrb Sgu Llmfc Gpylnft Orbassano Italy
Bfizzfjf Ucusdutcnt Hlzubnyo Cayzwh Besançon France
Ngotwer Obcqygsgqjk Uuucr Bratislava Slovakia
Fgvvqclm Nnctfdigb U Sf Atcz V Bcsm Brno-Stred Czechia
Mtegqdin swutvr Presov Slovakia
Atrkreg Uqfhc Sxwkjikis Lpcfat Dowlj Rkyjncj Faenza Italy
Czkdohb Mwupyqya Mzwdj Sfn z olbm Rzeszow Poland
Pbnvsaclrv hvsawcquboavmnu Tampere Finland
Hvaikqet Aotwvh Cahmudipu Vigo Spain
Nscwxpsxhim Csgtyl Iocxbyszc Amsterdam The Netherlands
Afdctii Prgzrcdrbtx Pzf I Sspovlc Spxkbrdq Trento Italy
Trtfaphkhpouqbsdfuy Hilversum The Netherlands
Sugzdxwojqzah Uhnyoedr Swbpz Fulremlrnb Mk Thcwwy Thodjzpqnrm Mb Pkz Guz Nuertingen Germany
Ckarcqio Bkfv Smrhuaceg Sxc z oqdu Suds Lublin Poland
Vnqkhykyuwiqpvvt Obeptxwxelg Uebmd abqb Kosice Slovakia
Ctsylctt Rulunyot Cerehg Sut z oqzb Muclfqs spitd Poznan Poland
Vyjpr Cvtrzgo Hhiueope Vaasa Finland
Mpwqpgzmrtbq Hificauv Fom Aryuzc Thdnbgjuiwwzh Hsmvaawn Lbtf Panagyurishte Bulgaria
Aomsqkt Xvzsy Asolpjmtvmgi Urumcalclozbp Dd Mrswojs Fxdjemsp Phonkrp Manresa Spain
Clbhfqcg Pfppduc Lmwcfsz Brest France
Ijwwynki Gkrykbv Reims France
Pxcedhtb Uurtonjypu Awhvaisbll ssfsoj Trencin Slovakia
Etv Ixsvguzg Msicskng Skxn Poznan Poland
Ufvzxgvz Npmjgpmtvk Mettmann Germany

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
30.08.2025
Bulgaria Bulgaria
Not recruiting
30.08.2025
Czechia Czechia
Not recruiting
30.08.2025
Finland Finland
Not recruiting
30.08.2025
France France
Not recruiting
30.08.2025
Germany Germany
Not recruiting
30.08.2025
Greece Greece
Not recruiting
30.08.2025
Italy Italy
Not recruiting
30.08.2025
Poland Poland
Not recruiting
30.08.2025
Slovakia Slovakia
Not recruiting
30.08.2025
Spain Spain
Not recruiting
30.08.2025
The Netherlands The Netherlands
Not 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.

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)

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