Testing ifinatamab deruxtecan against docetaxel in advanced prostate cancer
Compares a study medicine with chemotherapy in men with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Key facts
- Where
- Chūō, Fukuoka, Gifu, Ginowan, Hamamatsu, Hiroshima, Kagoshima, Kahoku-gun, Kamakura, Kitakyushu, Kobe, Koshigaya, Kumamoto, Kurume, Kyoto, Minato, Nagano, Nagasaki, Nagoya, Niigata, Sakai, Sakura, Sapporo, Shinjuku, Tokushima, Tōon, Ube, and Yufu, JapanSee the 31 sites
- Phase
- Phase 3
Where in Japan
- University of Yamanashi Hospital (Site 1506)Chūō, JapanTaking people
- Harasanshin Hospital (Site 1517)Fukuoka, JapanTaking people
- Kyushu University Hospital (Site 1515)Fukuoka, JapanTaking people
- Gifu University Hospital (Site 1527)Gifu, JapanTaking people
- University of the Ryukyus Hospital (Site 1519)Ginowan, JapanTaking people
- Hamamatsu University Hospital (Site 1520)Hamamatsu, JapanTaking people
- Hiroshima University Hospital (Site 1512)Hiroshima, JapanTaking people
- Kagoshima City Hospital (Site 1528)Kagoshima, JapanNo longer taking part
- Kagoshima University Hospital (Site 1518)Kagoshima, JapanNo longer taking part
- Kanazawa Medical University Hospital (Site 1507)Kahoku-gun, JapanTaking people
- Shonan Kamakura General Hospital (Site 1530)Kamakura, JapanTaking people
- Hospital of the University of Occupational and Environmental Health, Japan (Site 1510)Kitakyushu, JapanTaking people
- Kobe University Hospital (Site 1511)Kobe, JapanTaking people
- Dokkyo Medical University Saitama Medical Center (Site 1502)Koshigaya, JapanTaking people
- National Hospital Organization Kumamoto Medical Center (Site 1524)Kumamoto, JapanTaking people
- Kurume University Hospital (Site 1516)Kurume, JapanTaking people
- University Hospital,Kyoto Prefectural University of Medicine (Site 1525)Kyoto, JapanTaking people
- The Jikei University Hospital (Site 1504)Minato, JapanTaking people
- Nagano Municipal Hospital (Site 1526)Nagano, JapanTaking people
- Nagasaki University Hospital (Site 1523)Nagasaki, JapanTaking people
- Nagoya University Hospital (Site 1508)Nagoya, JapanTaking people
- Niigata Cancer Center Hospital (Site 1529)Niigata, JapanTaking people
- Bell Land General Hospital (Site 1509)Sakai, JapanTaking people
- Toho University Sakura Medical Center (Site 1503)Sakura, JapanTaking people
- Hokkaido University Hospital (Site 1500)Sapporo, JapanTaking people
- Sapporo Medical University Hospital (Site 1501)Sapporo, JapanTaking people
- Tokyo Women's Medical University (Site 1505)Shinjuku, JapanNo longer taking part
- Tokushima University Hospital (Site 1513)Tokushima, JapanTaking people
- Ehime University Hospital (Site 1514)Tōon, JapanTaking people
- Yamaguchi University Hospital (Site 1522)Ube, JapanTaking people
- Oita University Hospital (Site 1521)Yufu, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06925737EU 2024-517423-40-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
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.
Inclusion: 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: 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 any of the following indicators of interstitial lung disease (ILD)/pneumonitis:; Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids; Has current ILD/pneumonitis; 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; The main exclusion criteria include but are not limited to the following:; Is unable to swallow tablets/capsules; Has a "superscan" bone scan.