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Investigator(s):
William L. Dahut, M.D. Principal Investigator Phone: 301-435-8183 dahutw@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov

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Key Eligibility Criteria:

• Histologically or cytologically proven metastatic, progressive, castrate-resistant prostate cancer
• Radiographic evidence of disease after primary treatment with surgery or radiotherapy that has continued to progress radiographically or biochemically (rising PSA levels on successive measurements) despite adequate androgen-deprivation therapy
• Metastatic disease, defined as at least one lesion on bone scan or at least one lesion that can be accurately measured in at least one dimension
• Must have had prior treatment with docetaxel
• No more than 7 days of treatment with ketoconazole in the past 12 months
• ≥ 18 years of age
• ECOG performance status ≤ 2
• Adequate organ function as defined by liver, kidney, and hematologic laboratory testing

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Study Outline:

• Screening physical examination and imaging studies to determine eligibility for the study
• Open-label, randomized, Phase II trial with a two-part design
• Part 1
• AMG 386 will be administered IV (through a vein) every week, on Days 1, 8, 15 and 22 of each 28-day cycle; abiraterone taken once daily by mouth and prednisone twice daily by mouth
• Part 2
• Patients will be placed in one of two groups:
• One group will have AMG 386 administered IV (through a vein) every week, on Days 1, 8, 15 and 22 of each 28-day cycle; abiraterone taken once daily by mouth and prednisone twice daily by mouth
• The other group will have abiraterone taken once daily by mouth and prednisone twice daily by mouth
• Cycles continue for as long as there is no progressive disease or unacceptable toxicity
• Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/6/12
Updated: 9/7/12