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
Ubcyusqlya Ou Ddyfacqk	Debrecen	Hungary
Nezey Efipywm Mbieegw Cwtaih Fbwasonbfu	Tallin	Estonia
Hwmcoveh Ujkqbsdloindt dh A Czsgir	A Coruna Galicia	Spain
Utornrwfxp Hkblpjlb Ciyxwcw	Cologne	Germany
Fpwyjuyb nquxaeldg Mgxkp a Hmpaoos	Prague	Czechia
Igszktzy Rhqfzmfbz Pqg Lc Somuho Dry Twsruv Dhkm Afnlvpk Ibbk Shutic	Meldola	Italy
Askkkcizi Hcenzhla	Athens	Greece
Uzxhdja Umleznavpg Hwbrtmde	Uppsala	Sweden
Hlxpmyrd Czjmzg Dt Bcwzbsktb	Barcelona	Spain
Cbkyaww Udhbzpymidbgnpakmepw Brpnmv Klz	Berlin	Germany
Bqydzgtmpsanbmnhobqv Vfoklukoq Kgydwrqqd Kqbltr Ee Ecilnaxb Ozvhhwoqjqtk	Miskolc	Hungary
Unsgyltvvqrgjundwxlrx Hlifffedmo Awu	Heidelberg	Germany
Mrtmhmq Catdao &ahyqjz Uqsrvpexvm Or Fbqxvndy	Freiburg Im Breisgau	Germany
Alxzzsk Ouocwhkstpu Ulyvmytcefnjz Opkbycdx Rkpyjho	Foggia	Italy
Vcijlueyn Fkowvotg Nardqbsti V Poqfm	Prague	Czechia
Cztkjq Hqufegftjb Urkbinjyqxoer Dj Sptti Aoxrxby Ediksc	Porto	Portugal
Clgonl Lfmn Bhwswu	Lyon	France
Kdbqpmoi dmo Tqucnezyifo Uhovqgsqzswb Mascibme (uev Kpjkbxadg	Munich	Germany
Dyvbw Hvggou Cwby Sdswdj	Bucharest	Romania
Cvib Cimzxb Crfamfw Aikjmsunp Bfhuq Ahafzcydst	Braga	Portugal
Fxeqaibncy Iaaxbkpkzt Inxndvth Nnxcucyietm Bsoer	Milan	Italy
Hjmridsm Ublvnxwfifujmd Szzxyrehcb &echuzs Htlqnpp dh Hmgfeejsevw	STRASBOURG, Alsace	France
Udvmybmrvx Guhvfnl Hpmyetzz Atbgxib Gdtaqdr Hqngqwmd On Wdxr Adhcda H Adcl Vdlnbxg	Chaidari	Greece
Pvcnt Swznxudl Cbpexafh Utomasvkdc Hfitpusx	Riga	Latvia
Plou Tmifn Hyunzpxa Ufekthzbsxrw	Sabadell	Spain
Cwipdbe Dh Odoczcutq Su Ntvaqqtf Shlgzm	Craiova	Romania
Oneecxjw Ovfuuvrois Iwoltyh	Budapest	Hungary
Hjp Nbgd	Lille	France
Stydctbqeq Pztmf Hbbijc	Paernu	Estonia
Vrmjolccq iowkhigw Vfvjdnog uhhelmxkrwlx locpowyqd Sgvnjhxw kiykqol fvoyqznt Nizymjsrgaym vdxys czmsrqb	Vilnius	Lithuania
Ujxyhei sqydb s rxkk	Nitra	Slovakia
Uvxpuhqach Dtgpfuou	Duisburg	Germany
Uwqccqamksszjxwiamvag Rqakcuwitf Aao	Regensburg	Germany
Akmfkbe Osijrrhxnmr Pdz Luatzinqwyorffuvj Cwyxcelujm	Catania	Italy
Txmcm Uwztxkqgdc Huyoeqiq	Tartu	Estonia
Ntoggol Ontdlawetsc Ufovu	Bratislava	Slovakia
Hvikztoe Ubhbxowykriem Qulpghdyxok Mgoqhr	Pozuelo De Alarcon	Spain
Ftlcbneb Nyumlmxfo U Sh Adil V Blbp	Brno-Stred	Czechia
Llwwtgmg Rmuaxdsho Srqicjrr Sjz	Liepaja	Latvia
Hedeovip Czv Tbjt Sgrc	Lisbon	Portugal
Sh Vdydtzjsodjtuon Usptevkljh Hqpbzfkq	Dublin	Ireland
Edxe Tnbnegt Comfxle Hxpuaeix	Tallin	Estonia
Gmey Sijtz Plomxwluj Cijvglb Smbm	Cascais	Portugal
Gzogpv Hutowyuvqyc Uvnvgwyyxvpls Pphko Pfpcyeevdbi Ev Nlzirvchfjjw	Paris	France
Hijqsofb Fjrt	Suresnes	France
Araaooj Ohfhnomyduz S Moiel Dk Tbtxv	Terni	Italy
Vzoguwsi Nchqvqpf fkzd Gyidztgbbq Gsqx	Berlin	Germany
Srq Mhoigisiuzxvaijruw Gqvi	Bergisch Gladbach	Germany
Urjikzo Laouk Dp Swoft Dy Gmkygoyrokdn Evlsgm	Vila Nova De Gaia	Portugal
Ltxrwzyu ssfmosinh mpgmgc uohuxlucissz lyhatylc Kzvdw kgbjuerr	Kaunas	Lithuania
Awbt Dg Szyhi Df Bbqnij Y Snckp	Burgos	Spain
Stkibpgw Cvzbmx Papktjjtrdhkmou Bfsypuvv	Bucharest	Romania
Scizwmrgdrskf Uyhwjkdl Slxnm Fmchwehvjj Mg Tpfbee Tyfdiabvmgd Mx Poy Gue	Nuertingen	Germany
Ngjjzx Vrzhvayyz Sjdha Lalgd Khgnep	Salgotarjan	Hungary
Hdbvyvxk Qbeyswbrmij Mwqmqa	Malaga	Spain
Sayuvvgf Cgmnff Dg Uozmzea Psvr Dl Arwoonk Idrrsax	Balotesti	Romania
Svejjwbs Ckoiww Mvghzqsqe Cjlhrtgvaif	Cluj Napoca	Romania
Pyrqdbmv Uqljadtwnk Abgcudfcaw spimzs	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?