Everolimus in Treating Patients With Newly Diagnosed Localized Prostate Cancer

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer Read More

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