Study of Weekly Cabazitaxel for Advanced Prostate Cancer

Inclusion Criteria

• •1. Patients who have given written informed consent.
• •2. Age ≥ 18 years.
• •3. ECOG 0-2.
• •4. Patients with a histologic or cytologic diagnosis of advanced prostate cancer (any Gleason grade).
• •5. Previous and ongoing castration by orchiectomy or LHRH agonists. Antiandrogen must be discontinued prior to study start.
• •6. Disease progression, clinically or radiologically documented, during or after treatment with docetaxel, with a minimum cumulative dose of 225 mg/m2.
• •7. "Unfit" patients defined as patients who satisfy at least one of the following criteria:
• •* ECOG 2
• •* Dose reduction due to febrile neutropenia during the previous treatment with docetaxel
• •* Radiation therapy affecting more than 25% of bone marrow reserve
• •8. Documented metastatic disease and progressing after docetaxel treatment. Progression criteria is considered any of the following three or more than one at once:
• •* Progressive elevation of PSA measured in three successive determinations one week difference between them at least;
• •* Should be considered progression of measurable disease by RECIST criteria;
• •* Bone progression as evidenced by the appearance of two or more new lesions on bone scan.
• •9. Patients who have received a maximum of one prior chemotherapy for metastatic disease.
• •10. Prior anticancer therapy should have been interrupted 28 days before the start of study treatment (the patient may have continued treatment with prednisone 5 mg bid.
• •11. Adequate blood, liver and kidney function:
• •* Hemoglobin \> 9.0 g/dl
• •* ANC \> 1.5 x 10\*9/L
• •* Platelets \> 100 x 10\*9/L
• •* AST/SGOT and ALT/SGPT \< 2.5 x ULN
• •* Bilirubin \< 1.0 x ULN
• •* Creatinine \<1.5 mg/dL 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 (see Annex 7 for formula)
• •12. Adequate baseline cardiac function (LVEF ≥ 50%).
• •13. Life expectancy ≥ 12 weeks.
• •14. Patients must agree to use an effective contraceptive method during treatment with the study drug and up to 1 month after ending the treatment.