UPCC 21825: A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)

Study of Investigational Medication Versus Chemotherapy in Metastatic Castration-Resistant Prostate Cancer

Enrolling By Invitation
18 years or above
Male
Phase 3
1440 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prostate Cancer, Prostatic Neoplasms
  • Age: 18 years or above
  • Gender: Male

Inclusion Criteria:

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

  • Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
  • Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening
  • Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI)
  • Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
  • Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy
  • Has recovered from adverse events (AEs) due to previous anticancer therapies

Exclusion Criteria:

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

  • Is unable to swallow tablets/capsules
  • Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis:
    1. Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids
    2. Has current ILD/pneumonitis
    3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary

    illnesses

  • Has uncontrolled or significant cardiovascular disease
  • Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)
  • Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities
  • Has a "superscan" bone scan

This study investigates metastatic castration-resistant prostate cancer (mCRPC). The purpose of this study is to compare the effectiveness of an investigational medication, ifinatamab deruxtecan, against standard chemotherapy in extending the lives of participants and delaying cancer progression.

Participants in the study will receive either the investigational medication or chemotherapy. The study will monitor how long participants live and how long they live without the cancer worsening. The study involves regular assessments, including imaging tests, to track the progression of the disease.

  • Who can participate: Men with confirmed adenocarcinoma of the prostate and progression of cancer while on androgen deprivation therapy are eligible. Participants must have metastatic disease and prior treatment with androgen receptor pathway inhibitors.
  • Study details: Participants will receive either the investigational medication or chemotherapy to evaluate the efficacy in treating prostate cancer.
Updated on 17 Jul 2026. Study ID: 25-1065
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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