Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer

Exclusion Criteria

• •1. Prior radionuclide therapy for CRPC
• •2. Prior docetaxel for CRPC. (Permitted if given for castration sensitive disease \> 6 months prior).
• •3. Antiandrogen therapy within 4 weeks of enrollment. However, patients with primary failure of secondary anti-androgen therapy OR symptomatic progression, objective progression and/or biochemical evidence of rising PSA less than 4 weeks after discontinuation of anti-androgen therapy will not have anti-androgen withdrawal responses and will not be excluded.
• •4. Preexisting peripheral neuropathy grade 2 or higher.
• •5. Other serious medical condition as judged by the investigator.
• •6. Active second malignancy that requires therapy.
• •7. Known brain or leptomeningeal metastases
• •8. Concurrent enrollment in any other investigational anticancer therapy
• •9. Treatment with any myelosuppressive agent within 30 days of enrollment
• •10. Presence of bulky visceral metastases, defined as any of the following:
• •1. ≥ 4 lung lesions (at least 1cm each in size in the longest diameter) or pulmonary lymphangitic metastasis
• •2. Liver metastases with sum of lesion diameters totaling ≥ 5cm
• •11. Evidence of neuroendocrine or small cell differentiation on prior biopsy
• •12. History of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80