Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study
- Patients must have histologically proven adenocarcinoma of the prostate.
- Patients must meet at least one of the following high risk criteria:
- PSA > 20
- Gleason score 8 or greater
- Presence of pathological Gleason grade 4 or higher as the majority sum on biopsy
- Greater than 50% of cores at time of biopsy positive for cancer
- Clinical Stage T3 Disease
- Patients must have PS of 0-1(ECOG) and medically deemed a surgical candidate for
- Age > or = to 18.
- Patients with a pre-existing peripheral neuropathy of equal to or greater than
grade two are ineligible.
- Serum Creatinine must be < or equal to 2.0mg/dl.
- Patients must currently not receiving any drug which is metabolized by
cytochrome P450-3A4 including the statins, cyclosporin, terfenadine and
- Prior to receiving any dose of docetaxel, patients should have absolute
neutrophil counts > 1,500, hemoglobin > 8.0 g/dl and platelet counts >
- Patients with bilirubin elevated above institutional upper limit of normal
(ULN)must be excluded. Transaminases (SGOT and/or SGPT) may be up to 5.0 x
institutional upper limit of normal (ULN) if alkaline phosphatase is < ULN, or
alkaline phosphatase may be up to 5 x ULN if transaminases are < ULN. However,
patients who have both transaminase elevation > 1.5 x ULN and alkaline
phosphatase > 2.5 x ULN are not eligible for this study (due to decrease
clearance of docetaxel and increased risk of toxicity).
- Patients receiving concurrent warfarin are eligible but require monitoring of
protime on a weekly basis.
- Patients with clinical stage T4 disease are not eligible.
- Patients must not had have received prior treatment with surgery, radiation or
- Patients with other primary malignancies previously treated with
chemotherapeutic agents are not eligible.
- Patients must not have had a history of peptic ulcer disease requiring treatment
with surgery or endoscleral.
- Patients requiring corticosteroids for other systemic diseases are not eligible.
- Patients with a history of severe hypersensitivity reaction to docetaxel or
other drugs formulated with polysorbate 80 are not eligible.
- All patients must sign informed consent.
- Men of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter.