Sirolimus Before Surgery in Treating Patients With Advanced Localized Prostate Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically determined adenocarcinoma of the prostate
• •* Stage T1c-T3b disease
• •* No evidence of disease that has spread beyond the prostate or seminal vesicles
• •No metastatic prostate cancer, including bone, visceral, brain, and lymph node metastases
• •Tumor Gleason score sum of 7-10 (4+3 and 3+4 allowed) with tumor involving at least 2 discrete core biopsy sections
• •Scheduled to undergo radical prostatectomy
• •No other subtypes of prostate cancer, including any of the following:
• •* Sarcoma
• •* Neuroendocrine tumors
• •* Small cell cancer
• •* Ductal cancer
• •* Lymphoma
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-1
• •WBC \> 3,500/mm\^3
• •Absolute neutrophil count \> 1,500/mm\^3
• •Platelet count \> 100,000/mm\^3
• •Hemoglobin \> 9 g/dL
• •Creatinine \< 2.0 mg/dL
• •Bilirubin \< 2 mg/dL
• •ALT and AST \< 2 times upper limit of normal (ULN)
• •Alkaline phosphatase \< 2 times ULN
• •Triglycerides and total cholesterol \< 2 times ULN
• •No history of allergy to sirolimus (rapamycin) or its derivatives
• •No uncontrolled medical condition that would increase risk or limit compliance with study requirements, including the following:
• •* Immunodeficiency
• •* Gastrointestinal disease that would limit ability to swallow, take oral medications, or absorb them
• •No active infections
• •No other concurrent malignancy
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •No prior chemotherapy, biologic therapy, radiotherapy, or immunotherapy for prostate cancer
• •No concurrent chronic treatment with immunosuppressants or medications that interfere with the metabolism of sirolimus (rapamycin)
• •No concurrent medication or agents that would interfere with the metabolism or excretion of rapamycin or its derivatives, including any of the following:
• •* Phenytoin
• •* Carbamazepine
• •* Cyclosporine
• •* Clarithromycin
• •* Clotrimazole
• •* Erythromycin
• •* Amiodarone
• •* Protease inhibitors used to treated HIV infection
• •* Cisapride
• •* Grapefruit juice
• •* Diltiazem
• •* Tacrolimus
• •* Hypericum perforatum (St. John's wort)
• •* Barbiturates
• •* Rifampin
• •* Phenobarbital
• •* Rifabutin
• •* Efavirenz
• •* Nevirapine
• •At least 7 days since prior herbal medicines and medications, including any of the following:
• •* Hydrastis canadensis (goldenseal)
• •* Uncaria tomentosa (cat's claw)
• •* Echinacea angustifolia roots
• •* Trifolium pretense (wild cherry)
• •* Chamomile
• •* Glycyrrhiza glabra (licorice)
• •* Dillapiol
• •* Naringenin
• •* Norfloxacin
• •* Atorvastatin
• •* Pravastatin
• •* Cimetidine
• •* Fluconazole