RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

Inclusion Criteria:

18 years of age or older
Histologically documented prostate cancer
Castration resistant prostate cancer defined as two rising PSAs on castration therapy
Baseline PSA of 2ns/mL or greater
Testosterone of 50ng/mL or less
Patients on LHRH agonist/antagonist must continue therapy at the recommended dosing intervals
Prior bicalutamide is allowed as long as treatment was for 6 months or longer
Metastatic disease is not required
Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
ECOG Performance Status equal to or less than 2
Adequate bone marrow and liver function as outlined by parameters in the protocol

Exclusion Criteria:

Prior treatment with any investigational drug within the preceding 4 weeks
Prior treatment with an mTOR inhibitor
Fasting lipids over the parameters outlined in the protocol
Chronic treatment with systemic steroids or another immunosuppressive agent
Patients should not receive immunization with attenuated live vaccines during study period or within one week of study entry
Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
Other malignancies within the past 3 years except for adequately treated or basal squamous cell carcinomas of the skin
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Known history of HIV seropositivity
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
Men able to conceive and unwilling to practice an effective method of birth control
Known hypersensitivity to RAD001 or other rapamycins or to its excipients
History of noncompliance to medical regimens