Astra Zeneca – Prostate Cancer – D361EC00001

People with Metastatic Castration-Resistant Prostate Cancer (mCRPC) are asked to participate in a research study being conducted by Montefiore Medical Center

You may be eligible to participate in this study if you:

• Are a male at least 18 years of age (≥ 20 years of age in Japan)
• Have histologically-confirmed prostate adenocarcinoma
• Have metastatic disease documented prior to randomization
• Have been previously treated with a next-generation hormonal agent (NHA) for prostate cancer for at least 3 months and shown evidence of disease progression
• Have evidence of mCRPC with the progression of disease despite androgen deprivation therapy
• Are a candidate for docetaxel and steroid therapy
• Able and willing to swallow and retain oral medication
• Agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm

You may NOT participate in this study if you:

• Have had Radiotherapy within 4 weeks before the start of study treatment
• Have had major surgery (excluding placement of vascular access, transurethral resection of the prostate, bilateral orchiectomy, or internal stents) within 4 weeks of the start of the study treatment
• Have brain metastases or spinal cord compression
• Have clinically significant abnormalities of glucose metabolism
• Have inadequate bone marrow reserve or organ function
• Have had previous allogeneic bone marrow transplant or solid organ transplant
• Have known human immunodeficiency virus (HIV) infection, Hepatitis B, or C

Contact Information
Mary Portes, Study Coordinator
1695 Eastchester Road Bronx, NY 10461
Phone: (718) 405-8209