Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

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