Neoadjuvant CCI-779 Followed By Radical Prostatectomy in Treating Patients With Newly Diagnosed Prostate Cancer Who Have a High Risk of Relapse

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate
• Diagnosis based on a minimum of 6 core biopsy samples
• Clinically confirmed organ-confined disease
• Candidate for radical prostatectomy
• No evidence of metastatic disease by CT scan and bone scan
• High risk of relapse based on either of the following criteria:
• Any one of the following:
• Stage T2C or higher
• Gleason score greater than 7
• Prostate-specific antigen (PSA) greater than 20 ng/mL OR
• Any two of the following:
• Gleason score at least 7
• PSA 10-20 ng/mL
• Greater than 50% of total biopsy cores with cancer involvement

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• No active bleeding
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic

• No acute or chronic hepatitis B
• Hepatitis B surface antigen negative
• No acute or chronic hepatitis C
• No antibodies to hepatitis C
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 2 times ULN

Renal

• No ongoing urinary tract infection necessitating rapid or emergent surgical resection
• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No unstable angina
• No myocardial infarction within the past 6 months
• No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy

Pulmonary

• No known pulmonary hypertension
• No pneumonitis

Other

• Fertile patients must use effective contraception during and for 12 weeks after study participation
• HIV negative
• No other severe immunocompromised states
• No active infection requiring antibiotic therapy
• No serious concurrent illness
• No other major illness that would substantially increase the risk associated with study participation
• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy

Chemotherapy

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy

• More than 3 weeks since prior IV corticosteroids
• No concurrent systemic corticosteroids
• No prior or concurrent hormonal therapy for underlying malignancy

Radiotherapy

• No prior or concurrent radiotherapy

Surgery

• More than 3 months since prior major surgery

Other

• More than 1 month since prior experimental drugs
• More than 3 weeks since prior immunosuppressive agents
• No concurrent immunosuppressive therapies
• No other concurrent investigational agents
• No concurrent enzyme-inducing anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine)
• No concurrent ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, pimozide, or Hypericum perforatum (St. John's wort)
• No concurrent grapefruit or grapefruit juice