Study of PF-06821497 and Enzalutamide for Men with Advanced Prostate Cancer Resistant to Hormone Therapy

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What is this study about?

This clinical trial is focused on studying a condition known as metastatic castration-resistant prostate cancer. This is a type 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 investigating the effects of a new investigational medicine called PF-06821497, also known as Mevrometostat, in combination with another medication called enzalutamide. Enzalutamide is a treatment that is already used to manage prostate cancer. The purpose of the study is to see if the combination of PF-06821497 and enzalutamide is more effective than enzalutamide with a placebo in slowing down the progression of the cancer.

Participants in the study will be randomly assigned to receive either the combination of PF-06821497 and enzalutamide or enzalutamide with a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the investigational medicine and who is receiving the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for a period of time, during which participants will take the medications orally in the form of capsules or tablets. Regular check-ups and assessments will be conducted to monitor the participants’ health and the progression of the cancer.

The main goal of the study is to determine if the combination of PF-06821497 and enzalutamide can extend the time before the cancer worsens compared to the use of enzalutamide with a placebo. The study will also look at other outcomes, such as overall survival and the time it takes for the cancer to start growing again. Participants’ experiences with pain and quality of life will also be assessed throughout the study. This research aims to provide valuable information that could lead to improved treatment options for men with metastatic castration-resistant prostate cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current health status.

A diagnosis of metastatic castration-resistant prostate cancer is confirmed through medical records and imaging tests.

2 randomization

Participants are randomly assigned to one of two groups: one receiving the investigational medicine PF-06821497 with enzalutamide, and the other receiving a placebo with enzalutamide.

This process ensures that the study results are unbiased.

3 medication administration

Participants take the assigned medication orally. Enzalutamide is administered as a tablet.

The investigational medicine PF-06821497 or placebo is also administered orally in tablet form.

The dosage and frequency are determined by the study protocol and are monitored by the study team.

4 regular monitoring

Participants attend regular visits to monitor health status and response to treatment.

These visits include physical examinations, blood tests, and imaging studies to assess the progression of the disease.

5 assessment of treatment response

The effectiveness of the treatment is evaluated by measuring progression-free survival, which is the time during and after the treatment that the patient lives with the disease without it getting worse.

Other assessments include overall survival, time to pain progression, and changes in quality of life.

6 completion of study participation

Participants complete the study after a specified period or if the disease progresses significantly.

Final assessments are conducted to gather data on the long-term effects and benefits of the treatment.

Who Can Join the Study?

  • Male participants aged 18 years or older at the time of screening.
  • Confirmed diagnosis of prostate cancer, specifically a type called adenocarcinoma, without small cell features. If there is no previous diagnosis, a new biopsy is needed to confirm it.
  • The cancer has spread to the bones or soft tissues, as shown by specific scans like a bone scan or CT/MRI scan.
  • Participants must have low levels of testosterone, either due to surgery or medication, with a specific measurement of 50 ng/dL or less.
  • The disease must be getting worse despite low testosterone levels, shown by one or more of the following:
    • Increasing levels of a protein called prostate-specific antigen (PSA), with at least two rising measurements taken at least 7 days apart within the last year.
    • Worsening of soft tissue disease as defined by specific criteria called RECIST 1.1.
    • Worsening of bone disease with two or more new bone lesions, as shown by a whole-body bone scan.
  • Any side effects from previous treatments must have improved to a mild level or returned to the level they were before treatment, except for certain side effects like hair loss or nerve damage that are not considered a safety risk.
  • Participants must have a good level of daily functioning, as measured by a scale called ECOG performance status, with a score of 0 or 1, and a life expectancy of at least 12 months as assessed by the investigator.

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. Female patients are not eligible.
  • Patients who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.

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
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
Orszagos Onkologiai Intezet Budapest Hungary
Azienda Socio Sanitaria Territoriale Di Cremona Cremona Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Universita Cattolica Del Sacro Cuore Rome Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Næstved Hospital Næstved Denmark
Hospital Universitario 12 De Octubre Madrid Spain
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Urocentrum Praha s.r.o. Prague Czechia
Univerzitna Nemocnica Martin Martin Slovakia
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Poland
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Oulu University Hospital Oulu Finland
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Institut Godinot Reims France
Privatna Urologicka Ambulancia s.r.o. Trencin Slovakia
Region Skane Skanes Universitetssjukhus Lund Sweden
General University Hospital Of Larissa Larissa Greece
Jagiellońskie Centrum Innowacji Sp. z o.o. Cracow Poland
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Odense University Hospital Odense Denmark
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Alexandra Hospital Athens Greece
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Turku University Hospital Turku Finland
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
General University Hospital Of Patras Patras Greece
University Hospital Olomouc Olomouc Czechia
Pirkanmaan hyvinvointialue Tampere Finland
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Lyon Sud Pierre Benite France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Fakultni Thomayerova nemocnice Prague Czechia
Clinique Victor Hugo Le Mans France
Provita Centrum Medyczne Sp. z o.o. Tomaszow Mazowiecki Poland
University Hospital Ostrava Ostrava Czechia
Krajska nemocnice Liberec a.s. Liberec Czechia
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Soedersjukhuset AB Stockholm Sweden
Csuhxj Lfaa Bxgizi Lyon France
Uxsywekvsi Mtoljhh Ckirrd Hhlxphezzecslgkyz Hamburg Germany
Ikmhgq Ifcbrziw Ftwfguyoszrsa Ouiyhmmjdew Rome Italy
Iiopyuwu Chpdco Dpxtcucsqyeoiihha L'hospitalet De Llobregat Spain
Roiawdtfzf Sqxxqnf Sxilqaporrxhgod Irb Dmu Wlcafmwatq Bkhyoekfmojf Grudziadz Poland
Mmpj Cenrpjv Mchuxklh Trnpd Torun Poland
Cxcdxl swhyoo Bratislava Slovakia
Cgjmqii Oigswizc Cbordn Sspuk Zhbnxf Lfnc Stara Zagora Bulgaria
Nxqehd Vkpcylzqv Srpzt Lbrmp Konxok Salgotarjan Hungary
Mwudcutry smeknd Horovice Czechia
Ihnbjvql Rvtwooaoo Pyk Lv Sostat Dtw Ttreet Devg Aueywkm Iihp Sdkqbk Meldola Italy
Htppqolf Umkasqgrtn Chzxtoe Hhhaqqep Helsinki Finland
Ucezubkhvlwliwchdxtcu Mlzzduhw Amr Munster Germany
Grbxljjxsfvrxpaxu Vshhbarbl Pwzc Aepsae Ekytgpwg Odymog Kixgic Gyor Hungary
Asrnyb Mbkxfov Cpbccg Sacy Thessaloniki Greece
Nwmzdtxa Iftnnfzt Ooakfonfd Iyd Mpjcx Sqkorjyrdogumdyorffbqooatpdz Iznvreju Bcdaydrm Cracow Poland
Hnefedwn Uouxkquviawrgv Seneixpusd &vsnovu Hmrpxmt du Hhibkvpizml STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
10.01.2025
Czechia Czechia
Recruiting
10.01.2025
Denmark Denmark
Recruiting
10.01.2025
Finland Finland
Recruiting
10.01.2025
France France
Recruiting
10.01.2025
Germany Germany
Recruiting
10.01.2025
Greece Greece
Recruiting
10.01.2025
Hungary Hungary
Recruiting
10.01.2025
Italy Italy
Recruiting
10.01.2025
Poland Poland
Recruiting
10.01.2025
Slovakia Slovakia
Recruiting
10.01.2025
Spain Spain
Recruiting
10.01.2025
Sweden Sweden
Recruiting
10.01.2025
The Netherlands The Netherlands
Recruiting
10.01.2025

Trial locations

PF-06821497 (Mevrometostat) is an experimental medication being studied for its potential to treat metastatic castration-resistant prostate cancer. It is being tested to see if it can help slow down the progression of the disease when used in combination with another medication.

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 study, enzalutamide is used in combination with PF-06821497 to see if the combination is more effective than enzalutamide alone.

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to progress despite treatments that lower testosterone levels. It has spread to other parts of the body, such as bones or lymph nodes, beyond the prostate gland. The cancer cells in this condition are no longer responsive to hormonal therapy aimed at reducing male hormones. As the disease advances, it may cause symptoms like bone pain or urinary issues. The progression of the disease can vary, with some patients experiencing a more rapid spread than others. It is a challenging condition that requires ongoing management to control symptoms and slow progression.

Trial ID:
2024-511652-40-00
Protocol code:
C2321003
NCT ID:
NCT06629779
Trial Phase:
Therapeutic confirmatory (Phase III)

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