Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
- 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 >=
- Total bilirubin <= ULN
- AST, ALT and Alkaline Phosphatase must be within the range allowing for
- 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.
- Peripheral neuropathy > grade 1
- History of severe hypersensitivity to Taxotere® or other drugs formulated with
- 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.