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A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate Prostate01)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517423-40-00
Acronym
MK-2400-001
Enrollment
508
Registered
2025-06-10
Start date
2025-06-23
Completion date
Unknown
Last updated
2025-12-05

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), Radiographic progression-free survival (rPFS)

Detailed description

Time to first subsequent therapy (TFST), Objective response rate (ORR), Duration of Response (DOR), Time to pain progression (TTPP), Time to prostate-specific antigen (PSA) progression, PSA response rate, Time to first symptomatic skeletal-related events (SSRE), Number of Participants Who Experience One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Treatment Due to an AE

Interventions

DRUG-
DRUGPARACETAMOL
DRUGPREDNISONE
DRUGDOCETAXEL
DRUGPREDNISOLONE

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS), Radiographic progression-free survival (rPFS)

Secondary

MeasureTime frame
Time to first subsequent therapy (TFST), Objective response rate (ORR), Duration of Response (DOR), Time to pain progression (TTPP), Time to prostate-specific antigen (PSA) progression, PSA response rate, Time to first symptomatic skeletal-related events (SSRE), Number of Participants Who Experience One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Treatment Due to an AE

Countries

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

Outcome results

None listed

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