PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone

A 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

• To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer
• To evaluate PSA (tumor marker) response rate
• To evaluate safety

Inclusion Criteria:

• Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.

Exclusion Criteria:

• 1.Body temperature > 38 degree centigrade.
• 2.Prior radiotherapy to > 25% of bone marrow.
• 3.Prior isotope therapy and/or brachytherapy
• 4.Prior gene therapy.
• 5.Active double cancer.
• 6.Known brain or leptomeningeal involvement.
• 7.History of hypersensitivity reaction to drug
• 8.Other serious illness or medical condition
• 9.Subjects whom the investigators consider inappropriate from social or medical aspects.