RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer

Inclusion Criteria

• •Histologically confirmed diagnosis of adenocarcinoma of the prostate
• •Clinical or radiographic evidence of metastatic disease
• •ADT using LHRH agonist (eg leuprolide, goserelin) must continue on therapy. However, ketoconazole, estrogens, and all other forms of hormonal manipulation are not permitted on study.
• •Evidence of disease progression on ADT as evidenced by:
• •* 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, or
• •* Radiographic evidence of disease progression defined by RECIST criteria and compared to prior studies on ADT.
• •A minimum of 6 weeks has elapsed off of anti-androgen therapy without withdrawal response.
• •A minimum of 4 weeks from any prior radiation therapy, surgery, chemotherapy or other investigational agent
• •Biopsies will not be performed if platelet counts \< 75,000/ ul, PTT, PT or INR \> 1.4 times control
• •Patients must have normal organ and marrow function as defined below:
• •hemoglobin \> 9.0g/dL
• •absolute neutrophil count \> 1,500/μl
• •platelets \> 100,000/μl
• •total bilirubin \< 1.5 X upper limit of normal (ULN)
• •AST(SGOT)/ALT(SGPT) \< 2.5 X ULN
• •creatinine \< 1.5 X ULN
• •total fasting cholesterol \< 350
• •total triglycerides \< 300
• •Patients on antilipid therapy may participate in this study.
• •Age \> 18 years
• •ECOG performance status 0 or 1
• •Ability to swallow and retain oral medication
• •Ability to understand and the willingness to sign a written informed consent document.