Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
Status:
Not yet recruiting
Trial end date:
2028-05-01
Target enrollment:
Participant gender:
Summary
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.