A Study Looking at Novel Scheduling of Cabazitaxel for Patients With Metastatic Prostate Cancer

Inclusion Criteria:¨ * Histological confirmed prostate cancer * Macroscopic metastatic disease * Prior treatment with Docetaxel * Castration resistant disease defined as:Serum testosterone (\< 0.5 ng/ml) and: * Increase in measurable disease (RECIST 1.1, see appendix 10) or * For non-measurable disease, the appearance of at least one new lesion on nuclear scintigraphy) or * A rising PSA from the previous reference value on 2 consecutive occasions at least one week apart * Written informed consent Exclusion Criteria: * Less than 21 days since prior treatment with chemotherapy * Less than 14 days since radiotherapy or surgery to the start of cabazitaxel - Less than 4 weeks after stopping endocrine therapies including antiandrogen, abiraterone or other new agents. * Prior isotope therapy or radiotherapy to \> 30% of bone marrow (whole pelvic radiotherapy is not an exclusion criteria) * Persistent adverse events from previous cancer therapies \> grade 1 (CTCAE - Version 4.0) with the exception of alopecia. (With respect to peripheral neuropathy and nail changes grade 2 is acceptable) * ECOG performance status \> 1 * Known CNS malignancy * Within 6 months of randomization: * myocardial infarction, * unstable angina, * angioplasty, * bypass surgery, * stroke, * TIA, or * congestive heart failure NYHA class III or IV * Within 3 months prior to randomization: * treatment resistant peptic ulcer disease, * infectious or inflammatory bowel disease, * pulmonary embolism * Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results * History of hypersensitivity to docetaxel or polysorbate 80 * Inadequate organ and bone marrow function as evidenced by: * Hemoglobin \< 9.0 g/dL * Absolute neutrophil count \< 1.5 x 109/L, * Platelet count \< 100 x 109/L, * AST/SGOT and/or ALT/SGPT \> 1.5 x ULN; * Total bilirubin \> 1.0 x ULN, * Serum creatinine \> 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \< 60 mL/min should be excluded (http://mdrd.com/ for on-line calculation) * Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5. A one week wash out period is necessary for patients who are already on these treatments. * Patients with reproductive potential not implementing accepted and effective method of contraception.