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New hope for Hard-to-Treat prostate cancer: experimental drug combo trial opens

NCT ID NCT06353386

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This clinical trial is testing an experimental drug called opevesostat (MK-5684), either alone or combined with other cancer drugs, in people with a type of advanced prostate cancer that no longer responds to standard hormone therapy. The study involves 220 participants and has two phases: first to find safe doses, then to see if the treatments shrink tumors or lower PSA levels. It is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Opevesostat (MK-5684), olaparib, docetaxel, cabazitaxel, fludrocortisone acetate, dexamethasone, prednisone
What this could lead to
If successful, this could lead to a new treatment option that helps control advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 220 participants, so the treatments may not prove effective or safe in larger groups. Side effects from the drug combinations could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology. * Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening. * Evidence of disease progression from either, \>4 weeks from last flutamide treatment, or \>6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy. * Current evidence of metastatic disease. * Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment. * Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for \>4 weeks before randomization. * Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to \<Grade 1 or baseline. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy. * Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load. * Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * History of pituitary dysfunction. * Poorly controlled diabetes mellitus. * Active or unstable cardio/cerebro-vascular disease, including thromboembolic events and history of stroke or transient ischemic attack within 6 months before the first dose of study intervention, history of myocardial infarction within 6 months before the first dose of study intervention, New York Heart Association Class III or IV cardiac disease or congestive heart failure, coronary heart disease that is symptomatic, or unstable angina * History or family history of long corrected QT interval (QTc) syndrome. * Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML. * History or current condition of adrenal insufficiency. * History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications. * Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention. * Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization). * Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. * Received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities, requiring corticosteroids. * Received a live or live-attenuated vaccine within 30 days before the first does of study intervention. Administration of killed vaccines is allowed. * Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention. * Known additional malignancy that is progressing or has required active treatment within the past 3 years. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Active autoimmune disease that has required systemic treatment in the past 2 years. * Active infection requiring systemic therapy. * Concurrent active HBV or HCV infections.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostatic neoplasms, castration-resistant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    68 sites in 20 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aalborg Universitetshospital, Syd ( Site 0503)

    RECRUITING

    Aalborg, North Denmark, 9000, Denmark

  • Addenbrooke's Hospital ( Site 1902)

    RECRUITING

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

  • Ankara Bilkent Şehir Hastanesi ( Site 1801)

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center-Oncology ( Site 1500)

    RECRUITING

    Songpagu, Seoul, 05505, South Korea

  • Auckland City Hospital ( Site 1333)

    RECRUITING

    Auckland, 1023, New Zealand

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedal-Centro Ricerche Cliniche di Verona ( Site 1100)

    RECRUITING

    Verona, 37134, Italy

  • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1802)

    RECRUITING

    Adana, 01250, Turkey (Türkiye)

  • Bradfordhill ( Site 0300)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • CIDO SpA-Oncology ( Site 0302)

    ACTIVE_NOT_RECRUITING

    Temuco, Biobio, 4810218, Chile

  • Centre Hospitalier de l'Université de Montréal ( Site 0200)

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207)

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1402)

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

  • Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1702)

    RECRUITING

    Taoyuan, 333, Taiwan

  • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1704)

    RECRUITING

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800)

    ACTIVE_NOT_RECRUITING

    Berlin, 10117, Germany

  • China Medical University Hospital ( Site 1703)

    RECRUITING

    Taichung, 404332, Taiwan

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402)

    RECRUITING

    Bogotá, Bogota D.C., 111321, Colombia

  • Clinica Universidad Catolica del Maule-Oncology ( Site 0304)

    RECRUITING

    Talca, Maule Region, 3465584, Chile

  • Cork University Hospital ( Site 0902)

    RECRUITING

    Cork, T12 DC4A, Ireland

  • Docrates Syöpäsairaala ( Site 0602)

    RECRUITING

    Helsinki, Uusimaa, 00180, Finland

  • FALP ( Site 0301)

    ACTIVE_NOT_RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406)

    RECRUITING

    Bogotá, Bogota D.C., 110131, Colombia

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1103)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1102)

    COMPLETED

    Rome, Lazio, 00168, Italy

  • Fundación Valle del Lili-Oncology CIC ( Site 0403)

    RECRUITING

    Cali, Valle del Cauca Department, 760032, Colombia

  • Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)

    RECRUITING

    Greenslopes, Queensland, 4120, Australia

  • Gustave Roussy ( Site 0701)

    RECRUITING

    Villejuif, Île-de-France Region, 94805, France

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1800)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604)

    RECRUITING

    Helsinki, Uusimaa, 00029, Finland

  • Herlev and Gentofte Hospital ( Site 0501)

    RECRUITING

    Copenhagen, Capital Region, 2730, Denmark

  • Hopitaux Universitaires de Strasbourg ( Site 0700)

    RECRUITING

    Strasbourg, Bas-Rhin, 67200, France

  • Hospital Clinico San Carlos-Oncology Department ( Site 1604)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital General Universitario Gregorio Marañón ( Site 1601)

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1602)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1600)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702)

    RECRUITING

    Paris, 75015, France

  • IMAT S.A.S ( Site 0404)

    RECRUITING

    Montería, Departamento de Córdoba, 230002, Colombia

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703)

    RECRUITING

    Bordeaux, Aquitaine, 33076, France

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 1603)

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1804)

    RECRUITING

    Istanbul, 34668, Turkey (Türkiye)

  • Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1101)

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Jewish General Hospital ( Site 0206)

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Kyushu University Hospital ( Site 1204)

    RECRUITING

    Fukuoka, 812-8582, Japan

  • MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020)

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)

    RECRUITING

    Macquarie University, New South Wales, 2109, Australia

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400)

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Pontificia Universidad Catolica de Chile ( Site 0303)

    RECRUITING

    Santiago, Region M. de Santiago, 832000, Chile

  • Queen Elizabeth Hospital Birmingham ( Site 1903)

    ACTIVE_NOT_RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Rabin Medical Center ( Site 1001)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus-Oncology Division ( Site 1002)

    RECRUITING

    Haifa, 3109601, Israel

  • Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)

    ACTIVE_NOT_RECRUITING

    Preston, Lancashire, PR2 9HT, United Kingdom

  • Rutgers Cancer Institute of New Jersey ( Site 0033)

    ACTIVE_NOT_RECRUITING

    New Brunswick, New Jersey, 08903-2681, United States

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 1501)

    RECRUITING

    Seoul, 06351, South Korea

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1502)

    RECRUITING

    Seoul, 03722, South Korea

  • Sheba Medical Center ( Site 1000)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400)

    RECRUITING

    Valledupar, Cesar Department, 200001, Colombia

  • St. Vincent's University Hospital ( Site 0901)

    RECRUITING

    Dublin, Dublin, D04 T6F4, Ireland

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1803)

    RECRUITING

    Istanbul, 34722, Turkey (Türkiye)

  • Taipei Veterans General Hospital ( Site 1701)

    RECRUITING

    Taipei, 112, Taiwan

  • Tallaght University Hospital ( Site 0900)

    RECRUITING

    Dublin, D24 NR0A, Ireland

  • The Beatson West of Scotland Cancer Centre ( Site 1904)

    RECRUITING

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • The Jikei University Hospital ( Site 1202)

    COMPLETED

    Mitato, Tokyo, 105-8471, Japan

  • Toho University Sakura Medical Center ( Site 1201)

    RECRUITING

    Sakura, Chiba, 285-8741, Japan

  • UCLA Hematology/Oncology - Santa Monica ( Site 0044)

    RECRUITING

    Los Angeles, California, 90404, United States

  • UCSD Moores Cancer Center ( Site 0039)

    RECRUITING

    La Jolla, California, 92037, United States

  • Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804)

    RECRUITING

    Hamburg, 20246, Germany

  • Universitaetsklinikum Heidelberg ( Site 0805)

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitaetsklinikum Tuebingen-Urologie ( Site 0801)

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University College London Hospital ( Site 1905)

    RECRUITING

    London, London, City of, NW1 2PG, United Kingdom

  • University Hospitals Cleveland Medical Center ( Site 0043)

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049)

    ACTIVE_NOT_RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051)

    RECRUITING

    Miami, Florida, 33136, United States

  • Uniwersyteckie Centrum Kliniczne ( Site 1405)

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Vaasan Keskussairaala ( Site 0603)

    RECRUITING

    Vaasa, Pohjanmaa, 65130, Finland

  • Yokohama City University Medical Center ( Site 1203)

    RECRUITING

    Yokohama, Kanagawa, 232-0024, Japan

  • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0802)

    RECRUITING

    Munich, Bavaria, 81675, Germany

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