BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study

Inclusion Criteria:

- Histologic documentation of prostatic adenocarcinoma. Patients with small cell,
neuroendocrine or transitional cell carcinomas are not eligible.

- 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

Exclusion Criteria:

- 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