| Exclusion Criteria: | 1) Subjects from whom sufficient diagnostic biopsy material is not available for full characterization of the tumor.
2) Active infection requiring antibiotic therapy, or serious intercurrent illness, active bleeding, or ongoing urinary tract infection necessitating rapid or emergent surgical resection.
3) Severely immunocompromised subjects, including those known to be human immunodeficiency virus (HIV) positive.
4) Subjects with acute or chronic hepatitis B (HBsAg) or C (anti-HCV).
5) The use of immunosuppressive agents, including intravenous (IV) corticosteroids within 3 weeks of screening.
6) Presence of unstable angina, recent myocardial infarction (within the previous 6 months), or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia, known pulmonary hypertension, or pneumonitis.
7) History of malignancy in the 5 years before study entry, except basal cell and squamous cell skin cancer.
8) Subjects who have had an Orchiectomy.
9) Subjects who have had hormonal injection or implants, which will last longer than six months.
10) Subjects who have had antiandrogen treatment within 28 days prior to study entry.
11) Any other major illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study.
12) Concomitant therapy with any other experimental drug.
13) Therapy with other experimental drugs within 1 month of study entry.
14) Major surgery within 3 months of study entry.
15) Unwillingness or inability to comply with procedures required in this protocol. |