The purpose of this study is to evaluate the activity of FK228 in patients with metastatic prostate cancer who have developed a rising prostate specific antigen (PSA) while undergoing hormonal therapy.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

• Males > or equal to 18 years old
• Histological or cytological confirmation of metastatic prostate cancer with documented progression on hormonal therapy
• Patients must have either measurable disease or bone metastasis
• Rising PSA, with a minimum study entry PSA of > or equal to 5 ng/mL
• For patients treated with anti-androgens, elevation of PSA must be demonstrated after cessation of anti-androgen treatment

Exclusion Criteria:

• Prior treatment with chemotherapy
• Significant cardiac disease including congestive heart failure, history of myocardial infarction within one year of study entry, uncontrolled dysrhythmias, or poorly controlled angina
• QTc > or equal to 500 msec
• Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Previous extensive radiotherapy involving > or equal to 30% of bone marrow
• Coexistent second malignancy or history of prior malignancy within previous 5 years