Primary objectives:

• To determine the response rate, measurable and non measurable, to Taxotere® in the second line setting.

Secondary objectives:

• To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as second line therapy in HRPC
• To evaluate PSA response (PSA: Prostate Specific Antigen)
• To evaluate symptomatic response
• To evaluate Quality of life
• To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.

Inclusion Criteria:

• Histologically/cytologically proven prostate adenocarcinoma

• Progression or non response with previous chemotherapy regimen (excluding Taxotere®)

• Received previous mitoxantrone/prednisone or one other chemotherapy regimen including emcyt +/- vinblastine

• Castration levels of testosterone (<50 ng/dL )

• ECOG performance status 0-2

• Laboratory requirements :

  1. Hematology:

     • Neutrophils ≥ 1.5 x 10^9/L
     • Hemoglobin > 10 g/dL (prior transfusion permitted).
     • Platelets ≥ 100 x 10^9/L

  2. Hepatic function:

     • Total bilirubin < the upper-normal limit of the institution.
     • ALAT (SGPT) and ASAT (SGOT) ≤ 1.5 times the upper-normal limit of the institution.

  3. Renal function:

     • Creatinine ≤1.5 times the upper normal limit (i.e., NCI grade ≤1)

• No severe or uncontrolled disease

Exclusion Criteria

• Chemotherapy within the last 4 weeks
• Anti-androgen therapy within the last 4 weeks.
• Prior malignancy except the following: adequately treated non-melanomatous skin cancer and superficial bladder cancer from which the patient has been disease-free for >2 years.
• Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
• Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or OTC products for the treatment of prostate cancer must be stopped prior to study entry.
• Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including active uncontrolled infection and significant cardiac dysfunction.