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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	David Draper, R.N. Research Nurse Phone: 301-435-5614 draperd@mail.nih.gov	Lea Latham, R.N., B.S.N. Research Nurse Phone: 301-402-9137 llatham@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed metastatic androgen independent prostate cancer
• Radiographic evidence of disease by CT scan or bone scan after primary treatment that has continued to progress despite hormonal agents
• Progressive disease after one prior docetaxel-based cytotoxic chemotherapy but may have had no more than one previous cytotoxic chemotherapeutic line
• Patients who have not undergone bilateral surgical castration must continue suppression of testosterone production by appropriate usage of GnRH agonists
• No known active brain metastases
• Recovered from all prior therapy
• Concurrent bisphosphonates allowed provided the patient has been previously receiving that drug
• Patients on a chronic stable steroid for a non-cancerous condition are allowed
• Prior samarium-153 allowed
• No prior satraplatin or other platinum-containing compounds
• No prior radiotherapy to > 30% of the bone marrow
• No prior strontium chloride Sr 89, rhenium Re186, or rhenium Re188
• ECOG 0–2
• Leukocytes ≥ 3,000/μL; absolute neutrophil count ≥ 1,500/μL; platelets ≥ 100,000/μL; total bilirubin ≤ 1.5 x upper limits of normal (ULN) (except for patients with Gilbert disease); AST and ALT ≤ 2.5 x ULN; creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 60 mL/min
• Fertile patients must use effective contraception
• Must be able to swallow capsules
• No history of allergic reactions to compounds of similar chemical or biologic composition to satraplatin or prednisone
• No medical condition that would preclude study participation

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Treatment Plan:

• Patients receive oral satraplatin once daily on Days 1–5 and oral prednisone twice daily on Days 1–35
• Courses repeat every 35 days in the absence of disease progression or unacceptable toxicity
• Blood samples are collected for genotyping of ERCC1 and other gene polymorphisms via polymerase chain reaction

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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.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/6/08
Updated: 12/5/08