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

OBJECTIVES:

• Evaluate the impact of neoadjuvant sargramostim (GM-CSF) and thalidomide on pathologic response (histologic P0, margin positivity, capsular penetration), prostate-specific antigen (PSA) response, and other investigational endpoints in patients with high-risk prostate cancer undergoing prostatectomy.
• Determine the safety and feasibility of GM-CSF and thalidomide.

OUTLINE: This is an open-label study.

Patients receive sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5 and oral thalidomide on days 1-5 or 1-7 in weeks 1-4. Treatment repeats every 4 weeks for 2 courses in the absence of unacceptable toxicity.

Patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.

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