GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the prostate meeting any of the following criteria for high-risk disease:
• * Clinical stage II or III (T2b, T2c, or T3 with any grade or prostate-specific antigen \[PSA\])
• * Gleason score 7 (4+3 only) or ≥ 8 (any stage or PSA)
• * Serum PSA ≥ 10 ng/dL (any grade or stage)
• * Any stage, PSA, or Gleason score with ≥ 35% chance of biochemical failure at 5 years based on Kattan's nomogram
• No clinical evidence of CNS metastases
• No metastatic disease as demonstrated by radiological exam (CT scan, MRI, bone scan, x-ray) within 8 weeks of study entry
• Appropriate medical candidate for radical prostatectomy
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-1
• Creatinine ≤ 2.0 mg/dL
• Granulocyte count ≥ 1,800/mm³
• Platelet count ≥ 100,000/mm³
• AST \< 3 times upper limit of normal
• Bilirubin ≤ 1.5 mg/dL
• Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
• No active unresolved infection
• No pre-existing peripheral neuropathy \> grade 1
• No known HIV positivity
• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or controlled Ta transitional cell carcinoma of the bladder
• No known contraindication to sargramostim (GM-CSF) or thalidomide
• PRIOR CONCURRENT THERAPY:
• No prior radiotherapy to the prostate or pelvis
• No prior chemotherapy or hormonal therapy for prostate cancer
• No parenteral antibiotics within the past 7 days