Combining Docetaxel or Cabazitaxel with Darolutamide for Advanced Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of combining docetaxel or cabazitaxel with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). The study aims to evaluate whether the addition of darolutamide, an androgen receptor signaling inhibitor, can enhance the effectiveness of taxane chemotherapy in this patient population. Participants must have previously experienced disease progression on at least one androgen receptor signaling inhibitor and meet specific health criteria. The trial will assess treatment outcomes based on established progression criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years;
2. 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.
3. 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.
4. WHO performance ≤ 2
5. Able and willing to sign the Informed Consent Form prior to screening evaluations
6. Adequate haematological, renal and liver function and chemistry.

Exclusion Criteria:

1. Impossibility or unwillingness to take oral drugs
2. Hypersensitivity to taxanes
3. 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)
4. Symptomatic peripheral neuropathy CTCAE grade ≥2
5. Docetaxel-rechallenge.

Where it's running

• Erasmus MC Cancer Institute
  Rotterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Tanja van Dijk
• Email: interne.oncologie@erasmusmc.nl
• Phone: 0031107040704

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.