Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy

Inclusion Criteria

• •Signed informed consent
• •Histologically or cytologically confirmed prostate cancer that has progressed within 60 days of the start of screening despite castrate levels of testosterone from treatment with an LHRH agonist. Progression will be defined as one or more of the following: \*A rising PSA, defined as at least two consecutive rises in PSA over a reference value (PSA #1). The first rising PSA (PSA #2) must be taken at least one week after PSA #1. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2, OR
• •* The appearance of new metastatic lesions on a bone scan, OR
• •* Progression of known lesions or the appearance of new metastatic lesions on CT, MRI, chest x-ray, or other radiographic evaluations.
• •Subject whose hormonal therapy includes an anti-androgen must have the anti-androgen discontinued prior to the start of screening (at least 6 weeks for bicalutamide and at least 4 weeks otherwise). If there is a reduction in the PSA after anti-androgen withdrawal, the subject must continue to demonstrate progression as defined above after anti- androgen withdrawal to be eligible.
• •ECOG Performance Status ≤ 3
• •Age ≥ 18 years of age
• •Life expectancy ≥ 6 months
• •Serum testosterone less than or equal to 50 ng/dL
• •PSA ≥ 5 ng/mL (if progression is determined from a rise in PSA)
• •WBC greater than or equal to 3,000/mm3
• •Hematocrit ≥ 30%
• •Platelet count greater than or equal to 100,000/mm3
• •Serum creatinine less than or equal to 2 x upper limit of normal (ULN)
• •Bilirubin (direct or total) less than or equal to 2 x ULN
• •SGPT (ALT) and SGOT (AST) less than or equal to 2 x ULN