Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

Inclusion criteria

• Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC.
• Patient must have a serum testosterone > 180 ng/dl.
• Karnofsky performance status (KPS)>_70%.
• Patients must have adequate organ function as defined by the following
• laboratory criteria:
• WBC >_ 3500/mm3
• ANC >_1500/mm3
• Platelet count >100,000/mm3
• Hemoglobin >8.0g/dL
• Creatinine <1.6mg/dl
• Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL)
• SGOT and SGPT If alkaline phosphatase is _< 2.5 x ULN, any elevations in
• AST/ALT; OR if AST/ALT is _<1.5 x ULN, any elevation in alkaline phos
• Prior hormonal therapy is allowed as:

• Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy).
• One cycle of intermittent therapy up to a maximum exposure of 6 months (Proscar is not considered a hormone therapy).
• Patients must be at least 18 years of age.
• Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment

Exclusion criteria

• Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
• Uncontrolled serious active infection.
• Anticipated survival of less than 3 months.
• Active CNS or epiduraltumor
• Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
• Peripheral neuropathy >_ grade 3.
• Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
• Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment.
• Prior chemotherapy
• Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.