Study of PF-06821497 with Enzalutamide for Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate

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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 (mCRPC). 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 will explore the effects of an investigational medicine called PF-06821497 (also known as mevrometostat) when used in combination with another medication called enzalutamide. Enzalutamide is a treatment that helps to block the effects of testosterone on prostate cancer cells. The study will also compare this combination to the use of enzalutamide alone or another medication called docetaxel, which is a chemotherapy drug used to treat various types of cancer.

The purpose of the study is to determine if the combination of PF-06821497 and enzalutamide is more effective in prolonging the time patients live without their cancer getting worse, compared to enzalutamide or docetaxel alone. Participants in the study will be randomly assigned to receive either the combination of PF-06821497 and enzalutamide, enzalutamide alone, or docetaxel. The study will involve taking medications in the form of tablets or capsules, and for those receiving docetaxel, it will be administered as an infusion into a vein. The study will last for several weeks, and participants will have regular check-ups to monitor their health and the progress of their cancer.

Throughout the study, participants will be closely monitored for any changes in their condition and any side effects they may experience. The study aims to provide valuable information on the effectiveness and safety of the new treatment combination for men with metastatic castration-resistant prostate cancer who have previously been treated with another medication called abiraterone acetate. This research could potentially lead to new treatment options for patients with this challenging form of prostate cancer.

1 initial assessment

Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history and a series of tests to ensure you meet the study criteria.

You will be asked to provide consent to participate in the study, acknowledging that you understand the procedures and potential risks involved.

2 randomization

After the initial assessment, you will be randomly assigned to one of the treatment groups. This means you will either receive the investigational medicine PF-06821497 in combination with enzalutamide, enzalutamide alone, or docetaxel.

The assignment is random to ensure fairness and scientific accuracy.

3 treatment administration

If you are assigned to the PF-06821497 and enzalutamide group, you will take PF-06821497 orally in tablet form and enzalutamide as soft capsules. The specific dosage and frequency will be provided by the study team.

If you are in the enzalutamide group, you will take enzalutamide as soft capsules orally.

If you are in the docetaxel group, you will receive docetaxel intravenously, which means it will be administered through a vein.

4 monitoring and follow-up

Throughout the study, you will have regular visits to monitor your health and the effects of the treatment. This includes blood tests, imaging scans, and other assessments as needed.

You will be asked to report any side effects or changes in your health to the study team.

5 completion of study

At the end of the study period, you will have a final assessment to evaluate your overall health and the outcomes of the treatment.

The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who Can Join the Study?

Must be a male participant.
Must be at least 18 years old or older.
Must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of prostate cancer. If there is no previous diagnosis, a new biopsy (a small tissue sample) is needed to confirm it.
Must have metastatic disease, meaning the cancer has spread to other parts of the body, either in the bones or soft tissues, as shown by scans like bone scans, CT, or MRI.
Must be castrated, either surgically or medically, which means having low levels of testosterone (a male hormone) in the blood.
Must have progressive disease, meaning the cancer is getting worse, shown by one or more of the following:
- Rising levels of PSA (a protein produced by the prostate) in the blood, with at least two increases over a week apart in the last year. The PSA level at the screening must be at least 1 ng/mL if this is the only sign of progression.
- Progression of soft tissue disease as defined by specific criteria (RECIST v1.1).
- Progression of bone disease with two or more new bone lesions on a bone scan.
Must have recovered from any side effects of previous treatments to a mild level or to the level they were before treatment, except for hair loss or nerve damage in the hands and feet, which are not considered a safety risk.
Must have an ECOG performance status of 0 to 2, which is a scale used to assess how well a person can perform daily activities. Must also have a life expectancy of at least 6 months, as judged by the doctor.

Who Cannot Join the Study?

Patients who do not have metastatic castration-resistant prostate cancer. 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.
Patients who are not male. This study is only for male participants.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care, such as children or those unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Jean Perrin	Clermont Ferrand	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Hospital Universitario Hm Sanchinarro	Madrid	Spain
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
Frisius	Heerenveen	The Netherlands

Other Sites

Site Name	City	Country
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Antoine Lacassagne	Nice	France
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
Orszagos Onkologiai Intezet	Budapest	Hungary
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Alexandra Hospital	Athens	Greece
Hospital Clinic De Barcelona	Barcelona	Spain
Narodny Onkologicky Ustav	Bratislava	Slovakia
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Meander Medical Center	Amersfoort	The Netherlands
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
Hospital Foch	Suresnes	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Tergooiziekenhuizen	Hilversum	The Netherlands
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR	Nuertingen	Germany
Univerzitna Nemocnica Martin	Martin	Slovakia
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Opole	Poland
Fakultna Nemocnica Trnava	Trnava	Slovakia
Vychodoslovensky Onkologicky Ustav a.s.	Kosice	Slovakia
Centre Hospitalier Prive Saint-Gregoire	Saint-Gregoire	France
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Institut Godinot	Reims	France
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
Medikard s.r.o.	Presov	Slovakia
Centre Hospitalier Lyon Sud	Pierre Benite	France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Fakultni Thomayerova nemocnice	Prague	Czechia
Oncoradio Centre Oncogard	Nimes	France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Soedersjukhuset AB	Stockholm	Sweden
Ijyuozen Rwbooorul Pre Lk Sonsdr Duo Taodmv Dijh Algssxv Ixit Sfehna	Meldola	Italy
Govyjwsbifzinxpjp Vgtuwjwqr Pudi Aqdkej Etghnspk Ohgwpf Kimroj	Gyor	Hungary
Haekuguc Dy Lt Syqei Cuny I Sofm Pkp	Barcelona	Spain
Cxvalz Lkyw Bxahgt	Lyon	France
Uekpqrinfq Mhfzwsl Cebpas Heiuofszixcheitnk	Hamburg	Germany
Ijoajk Inebjiva Fzyhohhlycawb Orudhljlnei	Rome	Italy
Ieevckcg Caxbhg Dkspgvysfuemrkqac	L'hospitalet De Llobregat	Spain
Rmtzbpftwd Segxbce Spftrdzowfuepst Ikj Dfl Wxvpcxwzzf Bxhvupnsyeyj	Grudziadz	Poland
Mnjliwbfp Iuexnnincc Ciulfzpq Svqhbzvj Sbz z oveu	Warsaw	Poland
Mtshxqeky spbqgq	Horovice	Czechia
Ufrmdonw Ndttrzcdot	Mettmann	Germany
Ueykuoinuwqozstqxxmjm Mxlpcoap Atj	Munster	Germany
Aypsfp Msedvmq Cagalk Sfpp	Thessaloniki	Greece
Cpykmp Oszdi Lwtzbqt	Lille	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	15.12.2024
France	Not recruiting	15.12.2024
Germany	Not recruiting	15.12.2024
Greece	Not recruiting	15.12.2024
Hungary	Not recruiting	15.12.2024
Italy	Not recruiting	15.12.2024
Poland	Not recruiting	15.12.2024
Slovakia	Not recruiting	15.12.2024
Spain	Not recruiting	15.12.2024
Sweden	Not recruiting	15.12.2024
The Netherlands	Not recruiting	15.12.2024

Trial locations

Investigated drugs:

PF-06821497 (Mevrometostat) is an experimental medication being tested in this clinical trial. It is being studied to see if it can help treat prostate cancer that has spread to other parts of the body and is resistant to standard hormone therapy. This medication is being used in combination with another drug to see if it can improve the outcomes for patients who have already been treated with a medication called abiraterone acetate.

Enzalutamide is a medication that is already 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 being used both on its own and in combination with the experimental drug PF-06821497 to see if the combination is more effective than enzalutamide alone.

Docetaxel is a type of chemotherapy drug that is used to treat various types of cancer, including prostate cancer. It works by stopping cancer cells from dividing and growing. In this study, docetaxel is being compared to the combination of PF-06821497 and enzalutamide to determine which treatment is more effective in prolonging the time patients live without their cancer getting worse.

Investigated diseases:

Prostate cancer metastatic

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to progress despite treatments that lower testosterone levels. It is characterized by the spread of cancer cells beyond the prostate gland to other parts of the body, such as bones and lymph nodes. The disease progresses as cancer cells grow and multiply, often leading to increased pain and other symptoms. Over time, the cancer may become resistant to hormone therapy, which is initially used to control its growth. As the disease advances, patients may experience a range of symptoms related to the spread of cancer, including bone pain and urinary issues. The progression of the disease can vary, with some patients experiencing rapid changes while others may have a slower progression.

Trial ID:

2024-511650-50-00

Protocol code:

C2321014

NCT ID:

NCT06551324

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of PF-06821497 with Enzalutamide for Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?