Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

Exclusion Criteria

• •All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.
• •Clinically Localized Disease: Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:
• •Either CT or MRI of the abdomen and pelvis, that demonstrate no nodes \> 1 cm: or endorectal MRI(If one or more lymph nodes(s) measures \> 1 cm, a negative biopsy is required.)
• •Negative bone scan (with plain films and /or MRI and/or CT scan confirmation, if necessary).(Positive PET and Prostascint scans are not considered proof of metastatic disease.)
• •Patients must have high risk disease defined as either:
• •* Gleason Score 8-10
• •* PSA \> 15 ng/ml
• •* Stage T3a
• •* Stage T2c and Gleason score of 7
• •* Stage T2b, Gleason score of 7, greater than 50% of the cores positive from a single lobe.
• •No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, chemotherapy or hormone therapy.
• •Patient must be appropriate candidates for radical prostatectomy with an estimated life expectancy \> 10 years as determined by an urologist.
• •ECOG PS 0-1
• •Age \> 18 years of age.
• •Required initial laboratory values:
• •* ANC \> 1500/ul
• •* Platelet count \> 100,000/mm3
• •* Creatinine \< 2.0 mg/dl
• •* Serum PSA \< 100 ng/ml
• •* Bilirubin \< upper institutional limit of normal (ULN)
• •* AST/ALT \< 2.5 X ULN
• •Active or uncontrolled infection.
• •Patients must not have other coexistent medical condition that would preclude protocol therapy.
• •Previous severe hypersensitivity reaction to a drug formulated in CremophoreL (polyoxyethylated castor oil).
• •Grade 1 or greater neuropathy (motor or sensory) at study entry