Study Comparing MK-5684 with Abiraterone Acetate or Enzalutamide for Patients with Advanced Prostate Cancer After Hormonal 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, which is a type of advanced prostate cancer that continues to grow even when the amount of testosterone in the body is reduced to very low levels. The trial is comparing a new treatment called MK-5684 to existing medications, specifically abiraterone acetate and enzalutamide. These medications are used to treat prostate cancer that has spread to other parts of the body and has not responded to previous hormonal treatments.

The purpose of the study is to evaluate how well MK-5684 works compared to the other medications in terms of delaying the progression of the cancer and improving overall survival. Participants in the study will be randomly assigned to receive either MK-5684 or one of the alternative treatments. The study will involve regular check-ups and assessments to monitor the cancer’s response to the treatment. These assessments may include imaging tests like MRI or CT scans to track changes in the cancer.

Throughout the study, participants will be closely monitored for any side effects or changes in their condition. The trial aims to provide valuable information on the effectiveness and safety of MK-5684 as a potential new treatment option for patients with advanced prostate cancer. The study will continue for a set period, during which participants will receive the assigned treatment and undergo regular evaluations to assess their health and the progression of their cancer.

1 enrollment

Upon joining the study, confirmation of prostate cancer diagnosis is required. This includes a review of medical history and current health status.

Eligibility is determined based on specific criteria, such as previous treatments and current health conditions.

2 randomization

Participants are randomly assigned to receive either the new treatment MK-5684 or an alternative approved medication, such as abiraterone acetate or enzalutamide.

This process ensures that each participant has an equal chance of receiving any of the treatments.

3 treatment administration

The treatment involves taking oral medications. The specific medication and dosage depend on the group assignment.

Participants will take the medication as prescribed, with regular monitoring to assess the response to treatment.

4 monitoring and assessments

Regular check-ups are scheduled to monitor health status and treatment effects. This includes blood tests, imaging scans, and other necessary evaluations.

Participants are assessed for any side effects or adverse reactions to the treatment.

5 follow-up

After completing the treatment phase, follow-up visits are conducted to evaluate long-term effects and overall health.

The follow-up period helps in understanding the duration of response and any delayed side effects.

Who Can Join the Study?

Must have a confirmed diagnosis of prostate cancer, specifically a type called adenocarcinoma, without any small cell features.
Must have prostate cancer that has progressed while receiving a treatment called androgen deprivation therapy (ADT) or after surgical removal of the testicles within 6 months before the study starts.
Must have evidence of cancer that has spread to other parts of the body, shown by bone scans or imaging tests like CT or MRI.
Must have cancer that got worse during or after treatment with a specific type of hormonal therapy for prostate cancer, for at least 8 weeks (or 14 weeks if the cancer spread to bones). Participants may have received certain drugs like abiraterone acetate and docetaxel or darolutamide and docetaxel, but no more than six cycles of docetaxel and no worsening of cancer on scans while on docetaxel.
Must have had previous treatment with a type of drug called Poly polymerase inhibitors (PARPi) or have been considered unsuitable for this treatment by the doctor or have refused it.
Must be continuing with androgen deprivation therapy, with a testosterone level below 50 ng/dL.
Must have a performance status of 0 or 1 on a scale used to assess how well a person can perform daily activities, evaluated within 7 days before joining the study.
Must have adequate organ function, meaning the organs are working well enough.
Must provide a sample of tumor tissue from a recent biopsy of soft tissue that hasn’t been treated with radiation before. Samples from tumors that have grown back in a previously treated area are allowed.
If positive for hepatitis B, must have received antiviral therapy for at least 4 weeks and have no detectable virus before joining the study.
If previously infected with hepatitis C, must have no detectable virus at the time of screening.
If there were side effects from previous cancer treatments, they must have improved to a mild level or returned to the level before treatment. If there are hormone-related side effects, they must be well-managed with hormone replacement therapy, or if there is mild nerve damage, it is acceptable.
If infected with HIV, must have the infection well-controlled with antiretroviral therapy.

Who Cannot Join the Study?

Participants 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.
Participants who are female, as the study is only for male subjects.
Participants who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Institut Gustave Roussy	Villejuif	France
Centre Jean Perrin	Clermont Ferrand	France
Universitaetsmedizin Goettingen	Goettingen	Germany

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Karolinska University Hospital	Solna	Sweden
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Capio La Croix Du Sud	Quint-Fonsegrives	France
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
University Hospital Olomouc	Olomouc	Czechia
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Ukfhmvkeit Ob Dksinlfi	Debrecen	Hungary
Nivwb Egixjib Matkgwl Cgtecc Fgpwokazav	Tallin	Estonia
Hkbbksbm Uhjpioizlpjxm du A Ctlhrl	A Coruna Galicia	Spain
Uvzhciwzxu Hkaarpwp Cenlcne	Cologne	Germany
Feuspdjl ntfnvioga Mpolb a Hfyizdx	Prague	Czechia
Ibezfxct Rxyoqzixf Pdr Ls Sygwsj Dld Tgszzp Drok Atnppqr Ieut Sutkud	Meldola	Italy
Ainetsuzp Hxkdegys	Athens	Greece
Uqhdngc Uvdvczfnto Hlvfdkfb	Uppsala	Sweden
Hxuirivl Cjrczi Dd Bgdhgqhdf	Barcelona	Spain
Cwboqeb Uujpyelcffczislivrot Buzubw Kim	Berlin	Germany
Bgsdxikzmtalnwlylyrv Vpjmvechd Kuvgpfmxu Kjrvlq Es Exrwmass Ovgslkvwsesr	Miskolc	Hungary
Umuyznsmbhmrrxggbnvcd Hspjyhratz Ahy	Heidelberg	Germany
Mqspjlr Cnwpjn &nkonba Ukgkntyesw Ob Fwtvnlhh	Freiburg Im Breisgau	Germany
Atfkblj Ootixhgzyiv Uzcfwrmlsijef Ousiuvur Rquweqo	Foggia	Italy
Viahgfaxw Fkmxmvxu Ndworkrsa V Pjgfk	Prague	Czechia
Ctwjzk Hihqahlyqv Urjrxgjatslkp Ds Slyex Aakqygl Epvkbm	Porto	Portugal
Cmjqtd Ldau Bttjdl	Lyon	France
Kmpmtfng dan Tiagdwpgbkl Uizupqxdkkvf Mauavqzy (blq Koewxqmmo	Munich	Germany
Devqr Hepiha Cvzo Srrvkb	Bucharest	Romania
Cpey Cenjeo Cfcqbvq Auaximhpt Bbvnw Ajmkvzhtiu	Braga	Portugal
Fudtyknxek Izogukrkjp Iognubnb Nosctplqzem Bblmc	Milan	Italy
Hrsuusjs Urpzdlngyzjrsh Smvhhfmsto &qsayme Hwscngm dy Hlgbadqqfhn	STRASBOURG, Alsace	France
Urrwuobgat Giqwswz Hydobjyt Anbqcaf Ggpcjml Hpslkwir Oz Wagp Aahdtf H Aibp Vyjxdxw	Chaidari	Greece
Ptonb Scgjcunj Cxcrstqd Ucwaetfsvj Huqxuyci	Riga	Latvia
Plry Tmchq Hgzrqzxi Uooecxylbjmg	Sabadell	Spain
Caoctrb Dq Owwsfkich Sx Nhuetnik Sgoqxy	Craiova	Romania
Otefswyt Oqnjtgjgvs Isqnsqp	Budapest	Hungary
Hyd Nnqi	Lille	France
Sjlgjbbwff Peknp Hcakdp	Paernu	Estonia
Vmclozcdj iyamolhi Vivyojvo uevbuibeuvbn lqfbjudab Smecjzyk kwcbmzw fhcevxns Nfbvmerfohez vcsnq cdjwryx	Vilnius	Lithuania
Uoucinr svpxc s rafb	Nitra	Slovakia
Uzdcepwcko Daiwgtzv	Duisburg	Germany
Uzjuqjpbietqzqgprwelw Rkkpqthjfe Aqn	Regensburg	Germany
Auaaxfo Ogonvbuxneq Pbj Lnsjdisgsmnjxekdc Czhqfbhtui	Catania	Italy
Tikco Unrachzibv Haedqlth	Tartu	Estonia
Niyinwn Olpyhygdkvc Uosay	Bratislava	Slovakia
Hrvcfcin Uvcnckmdinlzo Qpkpvqjurab Masxum	Pozuelo De Alarcon	Spain
Fstxtezr Nouzkyzji U Sp Agay V Bfzj	Brno-Stred	Czechia
Lhtwzzgr Rnxycebnq Sprxczmj Sps	Liepaja	Latvia
Hiwzlsuf Csl Tajn Sltr	Lisbon	Portugal
Sm Vjzbsnqhfuftnwk Umaymhwgya Hespxrfd	Dublin	Ireland
Eatq Tipwhim Cuhsewm Hwsaspss	Tallin	Estonia
Gxxj Sokoz Psxwtdlmg Cdgoqja Srmd	Cascais	Portugal
Gbpevd Hhyiyawruzx Uzlhszgbsthrb Pzxlq Pvxqmsygpik Ep Ngfgnolksqti	Paris	France
Hnikvitz Fpbj	Suresnes	France
Auddgnd Ogiwjovvaqv S Muyeb Dr Tgkqx	Terni	Italy
Vldcgjqf Nmdrvbfx ffju Ghudqjqevh Gszy	Berlin	Germany
Sxb Mywmnnkitkaewzzjdp Gtvy	Bergisch Gladbach	Germany
Udjzrig Lwtdg Dn Smxai Dt Gbvbaroyesxv Exmoio	Vila Nova De Gaia	Portugal
Lwtwllua sxjfmgghl mvtozj uilquyaqnbnc lmzubfiy Klnjc kkbkbilo	Kaunas	Lithuania
Aqnd De Suoyf Da Batozx Y Srxio	Burgos	Spain
Sptvmbit Cekpmo Pncqaxyrmgcyanb Beacbbyp	Bucharest	Romania
Sltnpcdkrxtaw Uzekpuzg Sjhvg Fjtypxvpwj Mi Thjqar Tmkfusthkkk Mv Pbg Gbg	Nuertingen	Germany
Nsmlat Vizogtwuq Suqix Lvwqk Keivrg	Salgotarjan	Hungary
Hwxduvsc Qongynbkbuu Mxvomr	Malaga	Spain
Sbbgsylx Cnhtqa Dj Uhwyevp Pzrc Dj Atsfgxs Ifxxjqy	Balotesti	Romania
Smrtnakh Cmqwbg Mqjqqozhg Cdtymtiflsp	Cluj Napoca	Romania
Pzwhfxxn Ueifuukkud Ajdpgyhnaa salcwb	Trencin	Slovakia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.03.2024
Estonia	Recruiting	01.03.2024
France	Recruiting	01.03.2024
Germany	Recruiting	01.03.2024
Greece	Recruiting	01.03.2024
Hungary	Recruiting	01.03.2024
Ireland	Recruiting	01.03.2024
Italy	Recruiting	01.03.2024
Latvia	Recruiting	01.03.2024
Lithuania	Recruiting	01.03.2024
Portugal	Recruiting	01.03.2024
Romania	Recruiting	01.03.2024
Slovakia	Recruiting	01.03.2024
Spain	Recruiting	01.03.2024
Sweden	Recruiting	01.03.2024

Trial locations

Investigated Drugs:

MK-5684 is an investigational medication being studied for its effectiveness in treating metastatic castration-resistant prostate cancer (mCRPC). This medication is being compared to other treatments to see if it can help slow down the progression of the cancer and improve overall survival in patients who have already been treated with another hormonal therapy.

Abiraterone Acetate is a medication used to treat prostate cancer by reducing the production of male hormones that can promote the growth of cancer cells. In this study, it is used as a comparison treatment to evaluate the effectiveness of MK-5684.

Enzalutamide is another treatment option for prostate cancer that works by blocking the effects of male hormones on cancer cells. It is used in this trial to compare its effectiveness against MK-5684 in patients with metastatic castration-resistant prostate cancer.

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread to other parts of the body despite treatments that lower testosterone levels. It is characterized by the cancer’s ability to resist hormonal therapy, which is typically used to slow its progression. The disease often spreads to bones, lymph nodes, and other organs, leading to various symptoms depending on the areas affected. Patients may experience pain, fatigue, and other symptoms related to the spread of cancer. The progression of this disease can vary, with some patients experiencing rapid advancement while others may have a slower progression. The focus of research and treatment is often on managing symptoms and slowing the spread of the disease.

Trial ID:

2023-504957-11-00

Protocol code:

MK-5684-004

NCT ID:

NCT06136650

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing MK-5684 with Abiraterone Acetate or Enzalutamide for Patients with Advanced Prostate Cancer After Hormonal Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?