Tests darolutamide with docetaxel or cabazitaxel in advanced prostate cancer
Tests adding darolutamide to chemotherapy in men whose prostate cancer stopped responding.
Plain-language title generated from the registry record
Registry title: Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
Key facts
- Where
- Rotterdam, NetherlandsSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with metastatic prostate cancer that keeps growing despite hormone therapy (castration-resistant) and has already progressed on an ARSi drug. They would receive docetaxel or cabazitaxel with or without darolutamide.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Confirmed progressive metastatic castration-resistant prostate cancer (mCRPC), with an indication for docetaxel or cabazitaxel. Castrate testosterone level below 0.5 ng/mL.
- Earlier treatment
- Disease must have progressed on at least one ARSi (abiraterone, apalutamide, darolutamide or enzalutamide). Earlier docetaxel together with hormone therapy is allowed only if cabazitaxel is given in this trial. Docetaxel-rechallenge is not allowed.
Main reasons for not taking part
- Cannot take oral drugs or is unwilling to
- Hypersensitivity to taxanes
- Serious or unstable illness that could interfere with the trial, such as HIV, hepatitis, shingles, organ transplant, kidney failure, serious liver or heart or lung disease
- Symptomatic peripheral neuropathy of grade 2 or higher
- Docetaxel-rechallenge
Read by machine on 9 November 2026.
Where in Netherlands
- Erasmus MC Cancer InstituteRotterdam, NetherlandsTaking 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
- Erasmus Medical Center
- Trial code
- NCT05762536
- Record updated
- 10 September 2026
- Original description
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.Read full original descriptionShow less
A Randomized Phase II Trial of Docetaxel or Cabazitaxel With or Without Darolutamide in Men With Metastatic Castration-resistant Prostate Cancer
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.
Inclusion: Age ≥ 18 years; A confirmed diagnosis of progressive mCRPC (progression according to Prostate cancer Working Group (PCWG) 3 criteria, castration defined as castrate levels of testosterone of <0.5 ng/mL) with an indication for docetaxel or cabazitaxel; Patients should have had disease progression previously on at least one ARSi (abiraterone, apalutamide, darolutamide or enzalutamide). ARSi administration is allowed both in the mCNPC and in the mCRPC setting. Previous co-administration of docetaxel in mCNPC (triplet-therapy) is allowed, if patients will receive cabazitaxel in this study; WHO performance ≤ 2; Able and willing to sign the Informed Consent Form prior to screening evaluations; Adequate haematological, renal and liver function and chemistry.
Exclusion: Impossibility or unwillingness to take oral drugs; Hypersensitivity to taxanes; Known serious illness or medical unstable conditions that could interfere with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster, organ transplants, kidney failure, serious liver disease (e.g. severe cirrhosis), cardiac and respiratory diseases); Symptomatic peripheral neuropathy CTCAE grade ≥2; Docetaxel-rechallenge.