At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ifinatamab deruxtecan (drug), Docetaxel (drug), Prednisone (drug), Rescue Medication (drug)
- How long the study runs
- Study runs about 68 months (dates as stated)
- About the drug or intervention
- Ifinatamab deruxtecan — drug: Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment · Docetaxel — drug: Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment · Prednisone — drug: Oral tablet administered once per day or per approved product label · Rescue Medication — drug: Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 1,440
- Started
- 2025-05-13
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • Phase3 - 1,440 participants
- • Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer
- • Male only
Where?
- • Cambridge - Addenbrooke's Hospital ( Site 0915)
- • London - University College London Hospital ( Site 0920)
- • Exeter - Royal Devon & Exeter Hospital ( Site 0924)
- • Birmingham - Queen Elizabeth Hospital Birmingham ( Site 0923)
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
What the study is looking for
- ✓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...
- ✓Has current evidence of distant that has spread disease (M1 disease) documented by either bone lesions on bone scan...
- ✓Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after...
Who cannot take part
- ✗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:
- ✗Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did...
- ✗Has current ILD/pneumonitis
See the full criteria
Where Is This Study? (8 UK sites)
Addenbrooke's Hospital ( Site 0915)
Cambridge CB2 2QQ, United Kingdom
University College London Hospital ( Site 0920)
London NW1 2PG, United Kingdom
Royal Devon & Exeter Hospital ( Site 0924)
Exeter EX2 5DW, United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 0923)
Birmingham B15 2TH, United Kingdom
Mount Vernon Hospital ( Site 0921)
Northwood HA6 2RN, United Kingdom
St Bartholomew s Hospital ( Site 0925)
London EC1A 7BE, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 0922)
Sutton SM2 5PT, United Kingdom
Torbay Hospital ( Site 0918)
Devon TQ2 7AA, United Kingdom
How to Get in Touch
Toll Free Number
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