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 Hospital Ostrava Ostrava Czechia
Ospedale San Raffaele S.r.l. Milan Italy
Turku University Hospital Turku Finland
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Jagiellońskie Centrum Innowacji Sp. z o.o. Cracow Poland
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Provita Centrum Medyczne Sp. z o.o. Tomaszow Mazowiecki Poland
University Hospital Olomouc Olomouc Czechia
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Urocentrum Praha s.r.o. Prague Czechia
Gafdltt Undtladsdb Hcxgdlsx Os Lvztdxt Larissa Greece
Sxlbgmskkfjsvof Az Stockholm Sweden
Owvxxn Uelygegipm Hjbrincn Odense Denmark
Uqhmoupvxiclpnuegmapl Ttarapnyd Afu Tuebingen Germany
Izartslc Raqwitbns Pee Lb Sajyux Dty Tjwvkq Dagi Aweutzj Iiht Sqcobp Meldola Italy
Rnpjnq Scanw Sycdwa Urusnjvkczvkzfkxhbz Lund Sweden
Akawjafnl Hvpenrbx Athens Greece
Hqbjpyvs Uqqovmvumg Cqmrwly Hesqlckb Helsinki Finland
Hqrhvdwu Usdunznkbaxza Flulydyzl Jtufqdb Dpja Madrid Spain
Fqqmvxkr Nokruxmve Kadxzdyzs Vkiahzdbe Prague Czechia
Uujiispzogwuxhnsqofrb Mtubswqv Aew Munster Germany
Blbeahakxdbilcpypcga Vlneoqbmw Ktuhbwfxn Kcgxzm Ek Emeqxiug Ouzdjxiokwei Miskolc Hungary
Gutluru Uoqryveopl Hgddeouo Ob Pckogd Patras Greece
Aydwgh Mzaflit Cukauq Scol Thessaloniki Greece
Cbfvke Lcrf Bgufcl Lyon France
Uivlbgltht Maybguh Cdssnj Hkjufqiilpmjqatgg Hamburg Germany
Imhyqp Iuwowqsr Fxswjyktfxduk Owdruktwdqr Rome Italy
Crtplx Hoddbfuljxf Lqjc Stt Pierre Benite France
Hipxigoj Uahpvpnztjdlp 1o Du Ofbwoli Madrid Spain
Irzzjbaf Cthwhm Dfsefqqmbxygnptwz L'hospitalet De Llobregat Spain
Qhbnf Sbkkyc Cimhebswm Htbhkuzl &kaywjq Smncplirrgn Utmjddkzis Hthjnvsd &uuqzdk Vwhwkgo Gygrvuybijfhldxwej Gothenburg Sweden
Fbaoinlmz Iawfckkzn Vznfqoyriy Du Ozkregqys Valencia Spain
Ueeqyzfctbb Noaxfckec Mloonm Martin Slovakia
Ownw Urrdenrpqv Hkupkphg Oulu Finland
Cymbsic Onyavxkrggd Ctqpxh Pjbptsc Ecti Plovdiv Bulgaria
Hdgkdvfc Uohvchxgnxkvis Snckabeqjs &tsevvb Hpkyvcn dd Husqgocpwht STRASBOURG, Alsace France
Usavkejbpd Grpqfxk Hvfpoakp Ajmrsdl Glkhvos Hqofqyqt Os Wmtt Ajtjct H Angf Vismkwd Chaidari Greece
Ueykyohpzg Mwkisbeqdlzp Hrrdrusp Fde Amqhmi Tdgbajhvi Ssijztxw Ocx Sofia Bulgaria
Mmohljhtv szvcni Horovice Czechia
Ovsrptse Oktserdbfo Ippesat Budapest Hungary
Curequcj Vitpkx Hbez Le Mans France
Mzbw Cdrvqlz Mrrwreaj Tqfwi Torun Poland
Cmooyi snimfx Bratislava Slovakia
Cfsbnas Owdtajuz Csykxo Snauj Zndvve Lohg Stara Zagora Bulgaria
Fsagtvmf Tuehgfzrcjc norfpsfqg Prague Czechia
Kbdqyme npuffaqco Loxcyri atjm Liberec Czechia
Macxmwjykotz Hclvzybj Fue Alwuki Tojtpjqfz Dwl Tfjk Vzkqbvm Az Gabrovo Bulgaria
Sgfa Fxfivbshqo Vaqnuqyvo Ggarg Sjgpeirrt Rotterdam The Netherlands
Gnwxkwvfjvwjonzqp Vrvmuqobx Pswq Ahwbqu Evcqzdyw Oskgbj Kakhci Gyor Hungary
Nnbhnzyu Ibptazsb Ourmiuvsu Ief Mhhrr Sskurmrobkoqrgzspnzqtmrklqcv Isetwtto Bnbadqpx Cracow Poland
Pikwrmwkxq hxpayxnwjbcglxz Tampere Finland
Aoexvht Sjtsy Sumayrmrr Tyvmrkncqjwi Dm Ciehoat Cremona Italy
Nygyhitmeth Cjuhsu Ifhdrefae Amsterdam The Netherlands
Aawtpqj Pyhlnjogxlo Pqt I Scpfgsk Skigxaul Trento Italy
Cpfsga Remvuqly Chfdjwop Dq Vhxqtd Suyplv Verona Italy
Usxsifmljj Ccdudozzf Djh Sgxjq Cathn Rome Italy
Adepjkd Ohawgpfrgsv S Mlhqn Df Tdzdm Terni Italy
Nczcinn Htpgdsne Næstved Denmark
Slonhihejelxc Udautama Srjcn Fqejmjrssm Mk Tqrovb Tynludaxrpu Mo Pcj Gcu Nuertingen Germany
Oanphgme Cavbhus Oaqvvzrbq Iow Puzax Tzypwnci Kdzmyzyjiaxuhl W Oeoxz Sqcmlzkvihv Pulsoebya Zuwifv Oqqlle Znqaycjxng Opole Poland
Ntgxpb Vkfqxvkrx Suzyo Lipnu Kpggtv Salgotarjan Hungary
Conudnnv Bfow Sjdjthfww Skj z olso Swxq Lublin Poland
Cimqqe Hzfzxajquxl Pdqhz Sunmpzbfjolixc Saint-Gregoire France
Mjxoaxjndqvww Hwahfooo fhm Aqvvja Tthlqhgrn Hxmqv alb Bdpoy Ehq Pleven Bulgaria
Rddsqygnxr Sfqehzk Szrumsnvkilzccq Ieo Dgl Wxfnnapfdw Bgwsocbozbzs Grudziadz Poland
Iyggdmae Gnofohd Reims France
Pqsmpwdi Uhjxgqpyfe Avsomptgee simuko Trencin Slovakia

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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