Clinical trial NCT01020305 (phase 1/phase 2, status: terminated)
Conditions: prostate cancer, prostatic neoplasms, castrate-resistant prostate cancer (crpc), androgen-insensitive prostate cancer, hormone-refractory prostate cancer, metastatic disease
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, B38.81, N42.31, Z87.430, N40.0, N40.1, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: temsirolimus, casodex (bicalutamide)
SMILES: CN1N=NC2=C(N=CN2C1=O)C(N)=O, CC(O)(CS(=O)(=O)C1=CC=C(F)C=C1)C(=O)NC1=CC(=C(C=C1)C#N)C(F)(F)F
Reason stopped: 
    decision by funding sponsor due to poor accrual
  
Eligibility criteria:

        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