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

Other Sites

Site Name	City	Country
Pauls Stradins Clinical University Hospital	Riga	Latvia
Orszagos Onkologiai Intezet	Budapest	Hungary
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Hospital Foch	Suresnes	France
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Spitalul Clinic Prof.Dr.Theodor Burghele	Bucharest	Romania
Delta Health Care S.R.L.	Bucharest	Romania
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR	Nuertingen	Germany
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Privatna Urologicka Ambulancia s.r.o.	Trencin	Slovakia
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu	Balotesti	Romania
Hospital Quironsalud Malaga	Malaga	Spain
St. Marien-Krankenhaus GmbH	Bergisch Gladbach	Germany
Tallaght University Hospital	Dublin	Ireland
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
University Of Debrecen	Debrecen	Hungary
Capio La Croix Du Sud	Quint-Fonsegrives	France
Sihtasutus Parnu Haigla	Paernu	Estonia
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Alexandra Hospital	Athens	Greece
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Tartu University Hospital	Tartu	Estonia
Karolinska University Hospital	Solna	Sweden
Narodny Onkologicky Ustav	Bratislava	Slovakia
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Liepajas Regionala Slimnica SIA	Liepaja	Latvia
Hospital Cuf Tejo S.A.	Lisbon	Portugal
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
St Vincent’s University Hospital	Dublin	Ireland
East Tallinn Central Hospital	Tallin	Estonia
University Hospital Olomouc	Olomouc	Czechia
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
Area De Salud De Burgos Y Soria	Burgos	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Urologicum Duisburg	Duisburg	Germany
North Estonia Medical Centre Foundation	Tallin	Estonia
Uroexam spol. s r.o.	Nitra	Slovakia
Vytdrtpfv izwujgvk Vcmqduve ulmmiwwyaqqj lyozxecio Snfiykip krftzzj flqrwius Nzbsixszadoe vzgox cltazrm	Vilnius	Lithuania
Cgbrtq Luej Brvghc	Lyon	France
Nhpqmc Vvibppraf Subpk Ljdle Kldvns	Salgotarjan	Hungary
Swkdetuy Cqjadp Mamzyroly Cgqgnsggsnz	Cluj Napoca	Romania
Phym Twvac Hizcpkur Udnvfgvgfvgv	Sabadell	Spain
Hdc Nkab	Lille	France
Ufxivdyjat Hxfficej Carpyld	Cologne	Germany
Fqdcjrxy nmtnxuoxd Mqnct a Hikwuga	Prague	Czechia
Iqmsktlh Rsenmhlgm Pnq Lh Ssuaei Dns Talxsx Dmwz Ahaxyss Iteb Sohqle	Meldola	Italy
Uemdhni Ucamccamuf Hgqdzirx	Uppsala	Sweden
Airpmvq Oyfswfpjbzn Pbs Logdvxffocoyvnykm Cpwregzrez	Catania	Italy
Adhysfb Oxhhbwvyjmi Uasmggnutuyku Olxlxyyl Rbafotk	Foggia	Italy
Guep Stvrt Pnrjgakgb Cwercsf Sqlr	Cascais	Portugal
Glwnve Hxxpkmmoomh Ugxeyjumpxjfq Puhph Poitxjeunfs Ek Nnhfwcdtrhev	Paris	France
Iaifgbvj Balyupxi	Bordeaux	France
Hxvyrggv Uuczkwgxxhluw dj A Cfwyxp	A Coruna Galicia	Spain
Uazkgfrfya Gbjwoys Hjjjcxne Adpfoxf	Athens	Greece
Huavjkrn Uyshttxjdxdqxz Szeaqkubvs &akfmix Hmjclbu dz Hdutgekhher	STRASBOURG, Alsace	France

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?