A Randomized Phase II Trial of Doxil With or Without Dexamethasone in Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer

Inclusion Criteria:

1. Patients with metastatic hormone refractory prostate cancer as defined by resistance
to both ablative therapy (with either LHRH agonists or orchiectomy) & anti-androgens.

2. Patients must have symptoms related to disease.

3. Patients must have PS 0,1,2 (ECOG).

4. Patients must have measurable disease (RECIST) or PSA > 5.

5. Patients must have adequate organ function as defined as follows: leukocytes >/=
3,000/mm3, absolute neutrophil count >/= 1,500/mm3, hemoglobin >/= 8.0g/dl, platelets
>/= 100,000/mm3, serum creatinine ULN. Liver transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional ULN if
alkaline phosphatase is transaminases are
6. Patients must have a left ventricular ejection fraction (LVEF) 50% by echocardiogram

7. Patients must have failed to respond to discontinuation of anti-androgens.

8. No previous therapy with anti-androgens, corticosteroids or estrogens in the last 4
weeks.

9. Previous radiation therapy is allowed if completed at least 4 weeks prior to study
entry & therapy was cumulatively administered to
10. Patients must be >18 years of age

11. Patients must have an expected survival of at least 4 months.

12. Patients must have the ability to understand & the willingness to sign a written
informed consent document.

13. Patients must be willing to use adequate contraceptive method during treatment and
for 3 months after completing treatment.

Exclusion Criteria:

1. Patients with previous history of cancer are excluded unless they have had curative
treatment completed >/= 5 years prior to entry onto study or had 1 of the following:
in situ carcinoma (any location), basal cell carcinoma, or non-metastatic squamous
cell carcinoma of the skin.

2. Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, uncontrolled diabetes mellitus, or psychiatric illness/social situations
that would limit compliance with study requirements or the ability to provide
informed consent.

3. Patients requiring any non study corticosteroids for any reason are excluded.

4. Patients who have received previous chemotherapy.

5. A history of cardiac disease with New York Heart Class II or greater, or clinical
evidence of congestive heart failure.

6. Patients may not be receiving any other investigational agents or have participated
in any investigational drug study within 4 weeks preceding initiation of treatment.

7. Major surgery within 4 weeks prior to study treatment start, or lack of complete
recovery from major surgery.

8. Patients with a lack of physical integrity of the upper gastrointestinal tract or
those who have malabsorption syndrome or inability to swallow tablets.

9. History of hypersensitivity reactions attributed to a conventional formulation of
doxorubicin HCL or the components of Doxil®