Everolimus in Treating Patients With Newly Diagnosed Localized Prostate Cancer

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed newly diagnosed, localized adenocarcinoma of the prostate, meeting any of the following criteria:

  * Clinical stage T2a, T2b, T2c, or T3 disease (any grade or 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 AND ≥ 35% chance of biochemical failure at 5 years based on Kattan's nomogram
* Recommended for radical prostatectomy
* Normal testosterone level
* No pure neuroendocrine or small cell prostate cancer
* No metastatic disease by CT scan, MRI, bone scan, or X-ray
* No clinical evidence of CNS metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

* ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
* ANC ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Hemoglobin ≥ 8 g/dL
* AST and ALT ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 1.5 times ULN
* PT/PTT normal (no anticoagulants)
* No active unresolved infection
* No known HIV positivity
* Fertile patients must use effective contraception during and for 6 months after completion of study therapy

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