Inclusion Criteria:

1. Patients must have a histologic or cytologic diagnosis of adenocarcinoma of the
prostate.

2. Patients must have low-bulk asymptomatic metastatic or biochemical recurrent disease
for which no curative therapy exists.

3. Patients must have documented evidence of PSA progression while receiving androgen
ablative therapy, i.e. must be hormone refractory.

4. The PSA must be > 5 μg/L at the time of study entry.

5. ECOG performance status of 0 or 1.

6. Age 18 years of age or older

7. Patients must have a life expectancy of at least 12 weeks.

8. Chemotherapy: No prior cytotoxic chemotherapy is permissible. Neoadjuvant or adjuvant
chemotherapy is permissible provided it was > 12 months prior to registration.

9. Hormonal Therapy:

- Prior hormone therapy in the form of medical or surgical castration is required.
Patients must be hormone refractory and have been previously and currently
treated with androgen ablative therapy.

- Patients may have received up to one line of non-steroidal anti- androgens in
combination with chemical or surgical castration. Use of prior Bicalutamide is
restricted to less than 3 months of continuous usage. Patients must be off
anti-androgens for at least 6 weeks prior to study entry.

10. Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks
has elapsed between the last dose and enrollment to the trial.

11. Steroids. Current treatment with steroids ≤ an equivalent of prednisone 20 mg day is
permitted.

12. Men of childbearing potential must use an effective form of contraception i.e. double
barrier method.

13. Laboratory Requirements - within 7 days prior to enrollment Hematology: Hemoglobin ≥
100g/L Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L INR ≤ 1.5 x upper limit of
normal Biochemistry: AST, ALT within normal limits Bilirubin within normal limits
Serum creatinine ≤1.5 x upper limit of normal

15. Patient consent must be obtained 16. Patients must be accessible for treatment and
follow-up. 17. Protocol treatment is to begin within 5 working days of patient
registration.

Exclusion Criteria:

1. Prior use of BAY 43-9006 or other VEGF/VEGFR or EGFR targeting agents.

2. Patients with a history of other malignancies, except: adequately treated
non-melanoma skin cancer or other solid tumours curatively treated with no evidence
of disease for > 5 years.

3. Patients with known brain metastases or leptomeningeal disease

4. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to BAY 43-9006 or other agents used in the study.

5. Other serious intercurrent illness or medical condition that might be aggravated by
protocol treatment including:myocardial infarction within 6 months prior to study
entry:

- myocardial infarction within 6 months prior to study entry

- congestive heart failure

- unstable angina

- cardiomyopathy

- unstable ventricular arrhythmia

- uncontrolled hypertension (systolic blood pressure ≥ 160, diastolic blood
pressure ≥100)

- controlled psychotic disorders

- serious infections

- peptic ulcer disease

- history of bleeding diathesis

6. Upper gastrointestinal or other conditions that would preclude compliance with oral
medication.

7. Patients with immune deficiency are at increased risk of lethal infections when
treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving
combination anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with BAY 43-9006. Appropriate studies will be undertaken
in patients receiving combination anti-retroviral therapy when indicated.

8. Patients who require large amounts of narcotic therapy to control pain (e.g. morphine
equivalent dose > 30 mg/day) since these patients would more appropriately be offered
systemic chemotherapy.

9. Patients who require therapeutic anticoagulation.