A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen

Inclusion Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of the prostate that is
refractory to hormone therapy and previously treated with a Taxotere®-containing
regimen.

2. Documented progression of disease (demonstrating at least one visceral or soft tissue
metastatic lesion, including a new lesion). Patients with non-measurable disease
must have documented rising prostate-specific antigen (PSA) levels or appearance of
new lesion.

3. Surgical or hormone-induced castration

4. Life expectancy > 2 months

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Exclusion criteria

1. Previous treatment with mitoxantrone

2. Previous treatment with <225 mg/m^2 cumulative dose of Taxotere (or docetaxel)

3. Prior radiotherapy to ≥ 40% of bone marrow

4. Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior
to enrollment in the study

5. Other prior malignancy, except for adequately treated superficial basal cell skin
cancer, or any other cancer from which the patient has been disease-free for less
than 5 years

6. Known brain or leptomeningeal involvement

7. Other concurrent serious illness or medical conditions

8. Inadequate organ function evidenced by unacceptable laboratory results

The investigator will evaluate whether there are other reasons why a patient may not
participate.