Combining Docetaxel or Cabazitaxel with Darolutamide for Advanced Prostate Cancer
A Randomized Phase II Trial of Docetaxel or Cabazitaxel With or Without Darolutamide in Men With Metastatic Castration-resistant Prostate Cancer
This study is testing if adding darolutamide to chemotherapy drugs docetaxel or cabazitaxel can help men with advanced prostate cancer feel better and improve their treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 245 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT05762536 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed progressive mCRPC who have previously progressed on at least one androgen receptor signaling inhibitor.
Not a fit: Patients who are hypersensitive to taxanes or have serious medical conditions that could interfere with the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with advanced prostate cancer.
How similar studies have performed: Previous studies have shown promising results with similar combinations in metastatic castration-naïve prostate cancer, suggesting potential for success in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rotterdam
- Erasmus MC Cancer Institute — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Tanja van Dijk
- Email: interne.oncologie@erasmusmc.nl
- Phone: 0031107040704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.