Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Taxane efficacy in metastatic prostate cancer is modest due to resistance development. Several clinical phase III studies in metastatic castration-naïve prostate cancer (mCNPC) patients have shown that adding an androgen receptor signalling inhibitor (ARSi) to patients receiving a taxane and androgen deprivation therapy (ADT) improves survival endpoints. Adding ARSi darolutamide to docetaxel+ADT in mCNPC patients resulted in a robust OS benefit (HR 0.68). Importantly, the combination of a taxane and darolutamide is not prone to a drug-drug interaction, while there is a detrimental CYP3A4 inducing effect in the case of enzalutamide, resulting in a significant and clinically relevant reduction of cabazitaxel plasma concentrations. The investigators have previously reported preclinical data showing that addition of an androgen receptor signaling inhibitor (ARSi) improves cabazitaxel efficacy, even in metastatic castration-resistant prostate cancer (mCRPC). As treatment options for mCRPC) patients are scarce and patients often develop drug resistance relatively early, a new treatment regimen for this population to delay drug resistance is highly desired. The investigators propose a randomized phase II trial to investigate the efficacy of docetaxel or cabazitaxel plus darolutamide compared to docetaxel or cabazitaxel monotherapy in men with metastatic CRPC, who have progressed on an ARSI.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Potwierdzony zaawansowany rak prostaty, który nie reaguje już na hormony i ma wskazania do chemioterapii (docetaxel lub cabazitaxel)
- •Wcześniejsza progresja nowotworu pomimo leczenia co najmniej jednym lekiem hamującym receptory androgenowe
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (skala WHO ≤ 2)
- •Chęć podpisania świadomej zgody na udział w badaniu
- •Prawidłowe wyniki morfologii, funkcji nerek i wątroby
✗ Disqualifies
- •Niezdolność lub brak chęci do przyjmowania leków doustnych
- •Nadwrażliwość na taksany (rodzina leków chemioterapeutycznych)
- •Poważne choroby układowe uniemożliwiające uczestnictwo (HIV, zapalenie wątroby, przeszczepy narządów, ciężka niewydolność nerek lub wątroby, choroby serca lub płuc)
- •Neuropatia obwodowa (uszkodzenie nerwów) o średniej lub wysokiej nasileniu
- •Ponowne zastosowanie docetaxelu (jeśli pacjent go już wcześniej otrzymywał)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 10, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Erasmus MC Cancer Institute
Rotterdam, Netherlands
Trial contact
Tanja van Dijk
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/11/2026.
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