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Prostatic Neoplasms, Castration-ResistantPhase 1/2NCT06353386

Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)

A Phase 1/2 study testing Opevesostat, Olaparib and Docetaxel in people with Prostatic Neoplasms, Castration-Resistant, run by Merck Sharp & Dohme LLC at 77 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Opevesostat, Olaparib and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
77 sitesin 20 countries
Study dates
20 May 2024to 15 Jan 2029
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

77 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

77 sites in 20 countries

United States7 sites, 5 recruiting

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

    Baltimore, Maryland, 21201

    Active, not recruiting

  • University Hospitals Cleveland Medical Center ( Site 0043)

    Cleveland, Ohio, 44106

    Study Coordinator, 216-844-3951

    Recruiting

  • UCSD Moores Cancer Center ( Site 0039)

    La Jolla, California, 92037

    Study Coordinator, 858-822-6100

    Recruiting

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

    Los Angeles, California, 90404

    Study Coordinator, 310-825-2631

    Recruiting

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

    Miami, Florida, 33136

    Study Coordinator, 305-243-1543

    Recruiting

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

    Milwaukee, Wisconsin, 53226

    Study Coordinator, 414-955-8296

    Recruiting

  • Rutgers Cancer Institute of New Jersey ( Site 0033)

    New Brunswick, New Jersey, 08903-2681

    Active, not recruiting

Other trials in United States

Chile5 sites, 3 recruiting

  • Fundación Arturo López Pérez ( Site 0301)

    Santiago, Region M. de Santiago, 7500921

    Active, not recruiting

  • Pontificia Universidad Catolica de Chile ( Site 0303)

    Santiago, Region M. de Santiago, 832000

    Study Coordinator, +56934331806

    Recruiting

  • Bradfordhill ( Site 0300)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56229490970

    Recruiting

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

    Talca, Maule Region, 3465584

    Study Coordinator, +56947532700

    Recruiting

  • CIDO SpA-Oncology ( Site 0302)

    Temuco, Biobio, 4810218

    Active, not recruiting

Other trials in Chile

Colombia5 sites, 5 recruiting

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

    Bogotá, Bogota D.C., 110131

    Study Coordinator, +573147968518

    Recruiting

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

    Bogotá, Bogota D.C., 111321

    Study Coordinator, 573103469453

    Recruiting

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

    Cali, Valle del Cauca Department, 760032

    Study Coordinator, +576023319090 - 4022

    Recruiting

  • IMAT S.A.S ( Site 0404)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, 605 3135342052

    Recruiting

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

    Valledupar, Cesar Department, 200001

    Study Coordinator, 57 3128385292

    Recruiting

Other trials in Colombia

Germany5 sites, 4 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800)

    Berlin, 10117

    Active, not recruiting

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

    Hamburg, 20246

    Study Coordinator, +4915222815585

    Recruiting

  • Universitaetsklinikum Heidelberg ( Site 0805)

    Heidelberg, Baden-Wurttemberg, 69120

    Study Coordinator, +496221565982

    Recruiting

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

    Munich, Bavaria, 81675

    Study Coordinator, +498941402522

    Recruiting

  • Universitaetsklinikum Tuebingen-Urologie ( Site 0801)

    Tübingen, Baden-Wurttemberg, 72076

    Study Coordinator, +4970712987235

    Recruiting

Other trials in Germany

Spain5 sites, 5 recruiting

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

    Barcelona, 08035

    Study Coordinator, +34934894374

    Recruiting

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

    L'Hospitalet de Llobregat, Barcelona, 08908

    Study Coordinator, +34932607744

    Recruiting

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

    Madrid, Madrid, Comunidad de, 28034

    Study Coordinator, 34913368263

    Recruiting

  • Hospital General Universitario Gregorio Marañón ( Site 1601)

    Madrid, 28007

    Study Coordinator, +34914269393

    Recruiting

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

    Madrid, 28040

    Study Coordinator, +34 91 330 35 46

    Recruiting

Other trials in Spain

Turkey (Türkiye)5 sites, 5 recruiting

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

    Adana, 01250

    Study Coordinator, 03223272727

    Recruiting

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1800)

    Ankara, 06230

    Study Coordinator, +90312 305 43 30

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 1801)

    Ankara, 06800

    Study Coordinator, 0090312 552 60 00

    Recruiting

  • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1804)

    Istanbul, 34668

    Study Coordinator, +902124143434

    Recruiting

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

    Istanbul, 34722

    Study Coordinator, +90 216 606 52 00

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom5 sites, 2 recruiting

  • Queen Elizabeth Hospital Birmingham ( Site 1903)

    Birmingham, B15 2TH

    Active, not recruiting

  • Addenbrooke's Hospital ( Site 1902)

    Cambridge, Cambridgeshire, CB2 2QQ

    Study Coordinator, +441223216083

    Recruiting

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

    Glasgow, Glasgow City, G12 0YN

    Active, not recruiting

  • University College London Hospital ( Site 1905)

    London, London, City of, NW1 2PG

    Study Coordinator, +442034472930

    Recruiting

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

    Preston, Lancashire, PR2 9HT

    Active, not recruiting

Other trials in United Kingdom

France4 sites, 4 recruiting

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

    Bordeaux, Aquitaine, 33076

    Study Coordinator, +33556333261

    Recruiting

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

    Paris, 75015

    Study Coordinator, +33 1 56 09 20 00

    Recruiting

  • Hopitaux Universitaires de Strasbourg ( Site 0700)

    Strasbourg, Bas-Rhin, 67200

    Study Coordinator, +33368766767

    Recruiting

  • Gustave Roussy ( Site 0701)

    Villejuif, Île-de-France Region, 94805

    Study Coordinator, +33 1 42 11 42 11

    Recruiting

Other trials in France

Italy4 sites, 3 recruiting

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

    Milan, Lombardy, 20133

    Study Coordinator, +390223904449

    Recruiting

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

    Rome, Lazio, 00168

    Completed

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

    Rozzano, Milano, 20089

    Study Coordinator, +390282244080

    Recruiting

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

    Verona, 37134

    Study Coordinator, +390458126564

    Recruiting

Other trials in Italy

Japan4 sites, 3 recruiting

  • Kyushu University Hospital ( Site 1204)

    Fukuoka, 812-8582

    Study Coordinator, +81-92-641-1151

    Recruiting

  • The Jikei University Hospital ( Site 1202)

    Mitato, Tokyo, 105-8471

    Completed

  • Toho University Sakura Medical Center ( Site 1201)

    Sakura, Chiba, 285-8741

    Study Coordinator, +81-43-462-8811

    Recruiting

  • Yokohama City University Medical Center ( Site 1203)

    Yokohama, Kanagawa, 232-0024

    Study Coordinator, +81-45-261-5656

    Recruiting

Other trials in Japan

Taiwan4 sites, 4 recruiting

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

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

    Study Coordinator, +886-77317123x3267

    Recruiting

  • China Medical University Hospital ( Site 1703)

    Taichung, 404332

    Study Coordinator, +886-975681629

    Recruiting

  • Taipei Veterans General Hospital ( Site 1701)

    Taipei, 112

    Study Coordinator, +886228757519

    Recruiting

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

    Taoyuan, 333

    Study Coordinator, +88633281200

    Recruiting

Other trials in Taiwan

Australia3 sites, 3 recruiting

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

    Greenslopes, Queensland, 4120

    Study Coordinator, +61 7 33947284

    Recruiting

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

    Macquarie University, New South Wales, 2109

    Study Coordinator, +61402856430

    Recruiting

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

    Melbourne, Victoria, 3000

    Study Coordinator, +61385595000

    Recruiting

Other trials in Australia

Canada3 sites, 3 recruiting

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

    Montreal, Quebec, H2X 3E4

    Study Coordinator, 5148908000x27466

    Recruiting

  • Jewish General Hospital ( Site 0206)

    Montreal, Quebec, H3T 1E2

    Study Coordinator, 5149479045

    Recruiting

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

    Québec, Quebec, G1J 1Z4

    Study Coordinator, 418-691- 5225

    Recruiting

Other trials in Canada

Finland3 sites, 3 recruiting

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

    Helsinki, Uusimaa, 00029

    Study Coordinator, 0035894711

    Recruiting

  • Docrates Syöpäsairaala ( Site 0602)

    Helsinki, Uusimaa, 00180

    Study Coordinator, 00358505001869

    Recruiting

  • Vaasan Keskussairaala ( Site 0603)

    Vaasa, Pohjanmaa, 65130

    Study Coordinator, 0035862136981

    Recruiting

Other trials in Finland

Ireland3 sites, 3 recruiting

  • Cork University Hospital ( Site 0902)

    Cork, T12 DC4A

    Study Coordinator, +353 0214922687

    Recruiting

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

    Dublin, Dublin, D04 T6F4

    Study Coordinator, +353012214000

    Recruiting

  • Tallaght University Hospital ( Site 0900)

    Dublin, D24 NR0A

    Study Coordinator, +353014144209

    Recruiting

Other trials in Ireland

Israel3 sites, 3 recruiting

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

    Haifa, 3109601

    Study Coordinator, 047776234

    Recruiting

  • Rabin Medical Center ( Site 1001)

    Petah Tikva, 4941492

    Study Coordinator, +97239378110

    Recruiting

  • Sheba Medical Center ( Site 1000)

    Ramat Gan, 5265601

    Study Coordinator, +972525505090

    Recruiting

Other trials in Israel

Poland3 sites, 3 recruiting

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

    Study Coordinator, +48523743525

    Recruiting

  • Uniwersyteckie Centrum Kliniczne ( Site 1405)

    Gdansk, Pomeranian Voivodeship, 80-952

    Study Coordinator, 48585844466

    Recruiting

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

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, 48225463381

    Recruiting

Other trials in Poland

South Korea3 sites, 3 recruiting

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

    Seoul, 03722

    Study Coordinator, +82222288138

    Recruiting

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

    Seoul, 06351

    Study Coordinator, +82234101767

    Recruiting

  • Asan Medical Center-Oncology ( Site 1500)

    Songpagu, Seoul, 05505

    Study Coordinator, +82230106095

    Recruiting

Other trials in South Korea

Denmark2 sites, 2 recruiting

  • Aalborg Universitetshospital, Syd ( Site 0503)

    Aalborg, North Denmark, 9000

    Study Coordinator, 97660000

    Recruiting

  • Herlev and Gentofte Hospital ( Site 0501)

    Copenhagen, Capital Region, 2730

    Study Coordinator, 38 68 94 38

    Recruiting

Other trials in Denmark

New Zealand1 site, 1 recruiting

  • Auckland City Hospital ( Site 1333)

    Auckland, 1023

    Study Coordinator, +6493074949

    Recruiting

Other trials in New Zealand

About this study

Official title: MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).

The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.

Being tested
Opevesostat, Olaparib, Docetaxel, Cabazitaxel, Fludrocortisone acetate
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OpevesostatDrug

    Also called MK-5684

    Oral Tablet

  • OlaparibDrug

    Also called LYNPARZA®

    Oral Tablet

  • DocetaxelDrug

    Also called TAXOTERE®

    IV Infusion

  • CabazitaxelDrug

    Also called JEVTANA®

    IV Infusion

  • Fludrocortisone acetateDrug

    Oral Tablet

  • DexamethasoneDrug

    Oral Tablet

  • PrednisoneDrug

    Oral Tablet

Study groups in NCT06353386
Study groupRoleWhat they receive
Arm A1: OpevesostatExperimentalParticipants receive 5 mg of opevesostat twice daily (BID) via oral tablet plus dexamethasone 1.5 mg by oral tablets once daily (QD) and 0.1 mg fludrocortisone acetate by oral tablet QD until progression or discontinuation.
Receives: Drug: Opevesostat; Drug: Fludrocortisone acetate; Drug: Dexamethasone
Arm A2: Olaparib + OpevesostatExperimentalParticipants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 300 mg of olaparib BID via oral tablet until progressive disease or discontinuation.
Receives: Drug: Opevesostat; Drug: Olaparib; Drug: Fludrocortisone acetate; Drug: Dexamethasone
Arm A3: Docetaxel + OpevesostatExperimentalParticipants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 75 mg/m^2 of docetaxel once every 3 weeks (Q3W) via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.
Receives: Drug: Opevesostat; Drug: Docetaxel; Drug: Fludrocortisone acetate; Drug: Dexamethasone; Drug: Prednisone
Arm A4: Cabazitaxel + OpevesostatExperimentalParticipants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 20 mg/m^2 of cabazitaxel Q3W via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.
Receives: Drug: Opevesostat; Drug: Cabazitaxel; Drug: Fludrocortisone acetate; Drug: Dexamethasone; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who experience one or more dose-limiting toxicities (DLTs)

    The following events, if considered drug related by the investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not laboratory value); Grade 4 hematologic toxicity lasting >7 days, except thrombocytopenia (Grade 4 thrombocytopenia of any duration, Grade 3 thrombocytopenia associated with clinically significant bleeding); Any nonhematologic adverse event (AE) >Grade 3 in severity should be considered a DLT (with exceptions); Any Grade 3 or Grade 4 nonhematologic laboratory value (if certain criteria are met); Febrile neutropenia Grade 3 or Grade 4; Prolonged delay (>2 weeks) in initiating treatment after the first 28 days due to study intervention-related toxicity; Missing >25% of study intervention doses as a result of drug-related AE(s) during the first 28 days; Grade 5 toxicity.

    Measured: Up to approximately 28 days

  2. Number of participants who experience one or more adverse events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 46 months

  3. Number of participants who discontinue study intervention due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 46 months

  4. Prostate-specific antigen (PSA) response rate

    The Prostate-specific Antigen (PSA) response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level will be confirmed by an additional PSA evaluation performed ≥3 weeks from the original response per Prostate Cancer Working Group (PCWG) criteria.

    Measured: Up to approximately 46 months

Secondary outcomes (6)

  1. Objective response rate (ORR)

    The ORR is defined as the percentage of participants with complete response (CR: disappearance of all target lesions per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1); and no evidence of disease (NED) on base scan per Prostate Cancer Working Group (PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG). ORR will be assessed by Blinded Independent Central Review (BICR).

    Measured: Up to approximately 46 months

  2. Radiographic progression-free survival (rPFS)

    rPFS is defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per modified RECIST 1.1 is ≥20% increase in the sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria is the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for ≥6 weeks. rPFS will be assessed by BICR.

    Measured: Up to approximately 46 months

  3. Overall survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 46 months

  4. Duration of response (DOR)

    DOR is defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of a least 5 mm. PD per PCWG is the appearance of >2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for >6 weeks. DOR will be assessed by BICR.

    Measured: Up to approximately 46 months

  5. Time to first subsequent anticancer therapy (TFST)

    TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.

    Measured: Up to approximately 46 months

  6. Time to pain progression (TTPP)

    TTPP is defined as the time from randomization to pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 "worst pain in 24 hours" and by opiate analgesic use.

    Measured: Up to approximately 46 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start20 May 2024
  3. Primary completion15 Jan 2029 (estimated)
  4. Study completion15 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06353386
Sponsor's protocol ID
5684-01A
Other IDs
MK-5684-01A, 2023-506288-33-00, U1111-1292-6912, jRCT2031240224, 2023
Status last verified
Oct 2026
First submitted
3 Apr 2024
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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