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MK-5684-003: A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504899-25-00
Acronym
MK-5684-003
Enrollment
393
Registered
2024-03-18
Start date
2024-04-04
Completion date
Unknown
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic castration resistant prostate cancer

Brief summary

Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) mutation-positive participants, OS in AR LBD mutation-negative participants

Detailed description

Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD mutation-positive participants, rPFS Per Prostate Cancer Working Group-modified RECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD mutation-negative participants, Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST), Objective Response (OR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review, Duration of Response (DOR) Per PCWG-modified RECIST 1.1 as Assessed by Blinded Independent Central Review, Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score), Time to Prostate-specific Antigen (PSA) Progression, Time to First Symptomatic Skeletal-related Event (SSRE), Number of Participants Who Experience an Adverse Event, Number of Participants Who Discontinue Study Treatment Due to an Adverse Event

Interventions

DRUGHYDROCORTISONE
DRUGFLUDROCORTISONE
DRUGPREDNISONE
DRUGDEXAMETHASONE
DRUGABIRATERONE ACETATE
DRUGPREDNISOLONE
DRUGENZALUTAMIDE

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) mutation-positive participants, OS in AR LBD mutation-negative participants

Secondary

MeasureTime frame
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD mutation-positive participants, rPFS Per Prostate Cancer Working Group-modified RECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD mutation-negative participants, Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST), Objective Response (OR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review, Duration of Response (DOR) Per PCWG-modified RECIST 1.1 as Assessed by Blinded Independent Central Review, Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score), Time to Prostate-sp

Countries

Austria, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026