Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

INCLUSION CRITERIA * Histologically-confirmed adenocarcinoma of the prostate, characterized as symptomatic castration-resistant prostate cancer (CRPC) * Serum PSA ≥ 2 ng/mL * Rising PSA on 3 consecutive occasions at least 1 week apart (not limited to the 30-day screening period) * Failure of bilateral orchiectomy and/or therapy with an LHRH agonist and bicalutamide * Castrate level of testosterone (\< 50 ng/dL) * Currently being treated with bicalutamide * No prior antiandrogen therapy except bicalutamide * Age ≥ 18 years * Life expectancy \> 6 months * Performance status * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * OR * Karnofsky performance status ≥ 80% * Ability to understand and the willingness to sign a written informed consent EXCLUSION CRITERIA * Radiotherapy for prostate cancer within 28 days prior to Day 1, except single-fraction radiotherapy for pain control * Prior treatment with mTOR inhibitors * Prior treatment with chemotherapy for prostate cancer * Symptomatic bone metastases (ie, asymptomatic bone metastases are eligible) * Visceral metastases * Absolute neutrophil count (ANC) \< 1500/uL * Platelet count ≤ 100 x 10e9/L * Total bilirubin ≥ 1.5 x Upper Limit of Normal (ULN) * Alkaline phosphatase \> 2.5 x ULN * AST \> 2.5 x ULN * ALT \> 2. 5x ULN * Serum creatinine \> 2.0 mg/dL * Hemoglobin \< 9 g/dL * Men with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period and for at least 3 months after completion of the study treatment * History of other malignancies within 5 years except for tumors with a negligible risk for metastasis or death, such as adequately-controlled basal cell carcinoma, squamous-cell carcinoma of the skin, or early-stage bladder cancer * Participation in another experimental drug study either planned or within 4 weeks of the first study treatment * Persistent Grade ≥ 1 AEs due to prior drug therapy, including investigational drugs, administered more than 14 days before study enrollment * Previously treated or other known brain metastases * Ongoing or active infection * Symptomatic congestive heart failure, New York Heart Association Grade II or greater * Unstable angina pectoris * Cardiac arrhythmia * Significant vascular disease (eg, aortic aneurysm, aortic dissection) * Symptomatic peripheral vascular disease * Psychiatric illness/social situations that would limit compliance with study requirements * Other uncontrolled intercurrent illness * Known to be positive for the human immunodeficiency virus (HIV) infection and receiving antiretroviral therapies (HIV positive not requiring antiretroviral therapy iseligible if all other entry criteria are meet) * Inability to comply with study and/or follow-up procedures