Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation

Inclusion criteria

• Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following:

• Node positive disease post-operatively
• Capsule involvement
• Seminal Vesicles involvement
• Gleason score ≥ 8
• >50% of core biopsies that are positive
• Clinical Stage T2c and T3
• Pre-op PSA > 15 plus Gleason score of 7

• Age greater than 18
• ECOG Performance Status 0-1
• Serum creatinine <= 1.5 mg/dl
• Granulocyte count >= 1500/m3, Hemoglobin > 8.0 g/dl, and platelet count >= 100,000/m3
• Total bilirubin <= ULN
• AST, ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
• Signed patient informed consent.
• Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.

Exclusion criteria

• Peripheral neuropathy > grade 1
• History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate 80.
• Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent.
• Active infection within 14 days of beginning treatment
• Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection.
• Patients with a current malignancy. Patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.