DAROTAXEL

You may be able to join if

• Age ≥ 18 years;
• A confirmed diagnosis of progressive mCRPC (progression according to Prostate cancer Working Group (PCWG) 3 criteria), with an indication for docetaxel or cabazitaxel. Progression defined as ≥ 1 of the following 3 criteria: a. Radiographic disease progression in soft tissue per RECIST v1.1 b. Radiographic disease progression in bone defined by the appearance of ≥ 2 new bone lesions on bone scan. c. PSA progression defined as ≥ 2 sequential rises in PSA obtained ≥ 1 week apart with a minimal starting value of ≥ 1 ng/mL. A PSA value ≥ 2 ng/mL is required at study entry.
• 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. Coadministration of docetaxel in mCNPC (triplet-therapy) is allowed.
• WHO performance ≤ 2 (see appendix A)
• Able and willing to sign the Informed Consent Form prior to screening evaluations
• Adequate haematological, renal and liver function and chemistry, defined as: a. Hemoglobin ≥ 6.0 mmol/L b. Platelets ≥ 100 x 109/L c. ALT/AST ≤ 3x ULN and ≤ 5x ULN in case of liver metastases d. Creatinine clearance ≥ 50 ml/min e. Serum testosterone ≤ 1.7 nmol/L