Abiraterone Acetate for Castrate Resistant Prostate Cancer

If a patient agrees to participate in this research study, he will be asked to undergo some
screening tests and procedures to confirm eligibility. Many of these tests and procedures are
likely to be part of regular cancer care and may be done even if it turns out the patient
does not take part in the research study. These tests and procedures include: a medical
history, physical exam, performance status, EKG, MUGA scan, bone scan, evaluation of the
patient's disease, blood tests and a urine test. If these tests show that the patient is
eligible to participate in the research study, he will begin the study treatment. If the
patient does not meet the eligibility criteria, he will not be able to participate.

Once confirmed eligible to participate in the study, the patient will be started on the
treatment. Patients will be seen in an outpatient setting. All patients will receive the
study drugs, abiraterone acetate and prednisone. For the purposes of this description, study
treatment will refer to abiraterone acetate in combination with prednisone.

Patients will take 4 tablets of abiraterone acetate by mouth daily. Patients will also take 1
tablet of prednisone by mouth twice a day. Patients will be given a study diary which
includes instructions on how and when to take the study medication.

During the first two months in the study, patients will make about 3 visits to the clinic.
Afterwards, patients will visit the clinic about once a month.

This study uses bone scans to assess worsening of subjects' prostate cancer (tumor
progression) in the bones. Because arthritis can cause spots to appear on the bone scans, the
scan is repeated a few weeks later. Cancer spots remain the same, but arthritis spots may
disappear. Prostate Specific Antigen (PSA) tests can also be unreliable in the first few
weeks after starting any new prostate cancer therapy. This is because the death of prostate
cancer cells as a result of a new treatment can release PSA leading to an initial higher
level in your blood. Such early rises in PSA can be mistaken for progression of a patient's
cancer.

Cancer treatments can be divided into periods of time called cycles. A cycle in this study
will last 28 days. At the start of each cycle of treatment, patients will be asked to visit
the clinic to have regular pre-scheduled checkups and lab assessments. During Cycle 1 of this
study, patients will be asked to come to the clinic twice for assessments, on Day 1 and Day
15. At these visits the study staff will talk to patients about the study in greater detail,
perform all study visit procedures and provide the study treatment. The staff may also
perform more tests and evaluations if needed.

If a subject continues to qualify for the study after Cycle 1, he will undergo a medical
review, physical exam and blood sample on Day 1 of each cycle. Throughout the study, patients
will be asked if you are experiencing any side effects. Subjects will be responsible for
keeping your doctor informed if they feel they are having a reaction to the study treatment.
In addition, subjects will be responsible for taking the medications on a daily basis as
directed. It is very important to inform the treating clinician of any missed doses and the
reasons why doses were missed, at each study visit. Patients will also be responsible for
returning unused medication or the empty bottle at each study visit.

On Day 1 of Cycles 4, 7, 10 and every third cycle for as long as patients remain on study a
blood sample for the CTC tests (about 2 tablespoons) will be collected. The following
additional procedures will be done on Day 1 of Cycles 4, 7, 10 and every third cycle
thereafter, and at Treatment Discontinuation: CT or MRI of abdomen and pelvis and bone scans.

After the final dose of study drug, patients will return for an End of Study Treatment Visit
(15-28 days from treatment discontinuation). The tests completed at this end of study visit
are the same as Cycle 1 Day 1.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Able to swallow the study drug whole as a tablet

- Willing to take abiraterone on an empty stomach

- Willing to use a method of birth control with adequate barrier protection

- Metastatic disease as documented by positive bone scan or metastatic lesions other
than liver or visceral metastasis on CT, MRI

- Asymptomatic or mildly symptomatic from prostate cancer

- Surgically or medically castrated

- Previous anti-androgen therapy and progression after withdrawal

- Life expectancy of at least 6 months

Exclusion Criteria:

- Active infection or other medical condition that would make corticosteroid use
contraindicated

- Uncontrolled hypertension

- Severe hepatic impairment

- History of pituitary or adrenal dysfunction

- Clinically significant heart disease as evidenced by myocardial infarction or arterial
thrombotic events in the past 6 months, severe or unstable angina, or NYHA Class III
or IV heart disease

- Have any condition that, in the opinion of the investigator, would compromise the well
being of the subject or the study or prevent the subject from meeting or performing
study requirements

- Have poorly controlled diabetes

- Have a history of gastrointestinal disorders that may interfere with the absorption of
the study agents

- Have a pre-existing condition that warrants long-term corticosteroid use in excess of
study dose

- Have known allergies, hypersensitivity or intolerance to abiraterone acetate or
prednisone or their excipients

- Pathologic finding consistent with small cell carcinoma of the prostate

- Liver, visceral organ or brain metastasis

- Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC

- Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1

- Radiation or radionuclide therapy for treatment of metastatic CRPC tumor within 2 or 6
weeks, respectively, of Cycle 1, Day 1

- Previous treatment with ketoconazole for prostate cancer for greater than 7 days

- Prior systemic treatment with an azole drug

- Prior flutamide treatment within 4 weeks of Cycle 1, Day 1

- Bicalutamide, nilutamide within 6 weeks of Cycle 1, Day 1

- Active or symptomatic viral hepatitis or chronic liver disease

- History of a different malignancy except for the following circumstances: disease-free
for at least 5 years and deemed by the investigator to be at low risk for recurrence
of that malignancy. Individuals with the following cancers are eligible if diagnosed
and treated within the past 5 years: basal cell or squamous cell carcinoma of the skin

- Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1