Everolimus in Treating Patients With Newly Diagnosed Localized Prostate Cancer

Exclusion Criteria

• •Known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus or temsirolimus) or to its excipients
• •Gastrointestinal (GI) disease, condition, or symptoms that may significantly impair GI function and alter the absorption of everolimus, including any of the following:
• •* Ulcerative disease
• •* Uncontrolled nausea
• •* Vomiting
• •* Diarrhea
• •* Malabsorption syndrome
• •Other active malignancy or malignancy at ≥ 30% risk for relapse after completion of therapy, except nonmelanoma skin cancer
• •Uncontrolled concurrent illness including, but not limited to, any of the following:
• •* Ongoing or active infection (e.g., bacterial, viral or fungal)
• •* Severely impaired lung function
• •* Uncontrolled diabetes (fasting serum glucose \> 1.5 times ULN)
• •* Liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent hepatitis)
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia
• •Psychiatric illness or social situation that would limit study compliance
• •Any underlying medical condition which, in the principal investigator's opinion, will make the administration of everolimus hazardous OR obscure the interpretation of adverse events
• •PRIOR CONCURRENT THERAPY:
• •More than 4 weeks since major surgery
• •More than 3 months since finasteride
• •No prior or concurrent radiotherapy to the prostate gland or pelvis
• •No prior hormones (e.g., luteinizing hormone-releasing hormone \[LHRH\] agonists, LHRH antagonists, or antiandrogens \[e.g., bicalutamide, flutamide, or nilutamide\]) and/or PC-SPES (or PC-x product) or estrogen-containing nutraceuticals
• •No prior rapamycin mTOR inhibitor
• •No prior small bowel resection that may significantly impair GI function and alter the absorption of everolimus
• •No prior or concurrent immunotherapy, chemotherapy, or other investigational therapy for prostate cancer
• •No other concurrent investigational or commercial agents
• •No other concurrent anticancer agents
• •No concurrent, chronic treatment with systemic steroids (except inhaled or topical steroids) or another immunosuppressive agent
• •No concurrent live vaccines
• •No concurrent strong inhibitors or inducers of the isoenzyme CYP3A administered as systemic therapy