Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer

An Extension Multicenter Phase II Open Label Non-comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer.

The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refractory prostate cancer.

Inclusion Criteria:

Patients who completed the 10 cycles of docetaxel administrations in the preceding XRP6976J/2101 study and wish to continue docetaxel administrations,and who have no alternative therapy for hormone refractory prostate cancer according to the Investigator's judgment.

Exclusion Criteria:

• Continuation in the study would be detrimental to the patient's well-being
• Development of life-threatening and/or toxic conditions not manageable by symptomatic care, dose reduction, or delay of dosing
• Obvious disease progression (rising prostate specific antigen, any increase of ≥ 20 % in the sum of the measurable lesion in comparison to the nadir value, and progression in non-measurable lesion)
• Patients treated with anti-cancer treatment other than study therapy after completion of 10 cycles of study treatment in the XRP6976J/2101 study