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Phase III

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

  • Study HIC#:2000040718
  • Last Updated:12/09/2025

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy,

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Katie Wildman

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    You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

    Eligibility Criteria

    Inclusion Criteria:

    The main inclusion criteria include but are not limited to the following:

    • Has diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
    • Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to entering the study
    • Has received prior treatment with 1 or 2 androgen receptor pathway inhibitor (ARPI) and progressed during or after at least 8 weeks of treatment

    Exclusion Criteria:

    The main exclusion criteria include but are not limited to the following:

    • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids
    • Has uncontrolled or significant cardiovascular disease
    • Has received prior treatment with a taxane-based chemotherapy agent for mCRPC

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: