Clinical trial NCT00512668 (phase 1, status: terminated)
Conditions: adenocarcinoma of the prostate, recurrent prostate cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: leuprolide acetate, goserelin acetate, bicalutamide, nilutamide, flutamide, temsirolimus
SMILES: CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O, CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O, [H][C@]12SCC(C)=C(N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=C(O)C=C1)C(O)=O, CC1(C)NC(=O)N(C1=O)C1=CC(=C(C=C1)[N+]([O-])=O)C(F)(F)F, CC(C)C(=O)NC1=CC(=C(C=C1)[N+]([O-])=O)C(F)(F)F, CN1N=NC2=C(N=CN2C1=O)C(N)=O
Eligibility criteria:

        Inclusion Criteria:

          -  All patients must sign an informed consent indicating that they are aware of the
             investigational nature of this study; patients must also have signed an authorization
             for the release of their protected health information

          -  Patients must have histologically confirmed adenocarcinoma of the prostate recurring
             after local therapy (radical prostatectomy and/or radiation therapy) as evidenced by
             rising serum PSA

          -  Prostate-Specific Antigen (PSA) Doubling Time (PSADT) =< 12 months after local therapy
             (prostatectomy and/or definitive radiation) as determined by linear regression of all
             available PSA values within 6 months of initiation of androgen ablation (for patients
             who underwent prostatectomy, at least one PSA measurement of >= 1.0 ng/mL; for
             patients who underwent radiation, at least one PSA measurement of >= 3.0 ng/mL and >=
             150% postradiation nadir)

          -  No evidence of metastasis as determined by bone scan or computed tomography (CT) scan

          -  Initiation of Androgen Ablation of less than 8 weeks' duration prior to study entry is
             permitted

          -  Leukocytes ≥ 3,000/mcl

          -  Absolute neutrophil count ≥ 1,000/mcl

          -  Hemoglobin ≥ 8.0g/dl

               -  Eligibility level for hemoglobin may be reached by transfusion

          -  Platelet count >= 100,000/μL

          -  Total bilirubin ≤1.5 X laboratory ULN

          -  AST and/or ALT ≤ 3 X laboratory ULN

          -  Creatinine ≤ 1.5 X laboratory ULN OR calculated creatinine clearance ≥ 60 ml/min/1.73
             m^2 for patients w/creatinine levels above the laboratory ULN

          -  Serum cholesterol level < 350 mg/dl

          -  Triglyceride level < 300mg/dl

          -  ECOG performance status 0, 1 or 2

          -  The effects of Temsirolimus on the developing human fetus are unknown; for this reason
             men must agree to use contraception from the time of study enrollment continuing for
             the duration of study participation

          -  Patients must be registered in the MDACC institutional database prior to treatment
             with study drug

          -  PSA < 40 ng/ml

        Exclusion Criteria:

          -  Patients with histologic variants other than adenocarcinoma in the primary tumor

          -  Patients may not be receiving any other investigational agents

          -  Patients may not be receiving concomitant immunotherapy or immunosuppressive therapy

          -  Patients may not have received prior systemic treatment for prostate cancer (other
             than no more than 3 months of prior treatment with androgen ablation in neoadjuvant
             and/or adjuvant setting and at least a year must have elapsed since last
             administration) unless initiation of Androgen Ablation of less than 8 weeks' duration
             prior to study entry is permitted

          -  Patient with uncontrolled intercurrent illness including, but not limited to ongoing
             or active infection requiring parenteral therapy on day 1 of protocol treatment,
             symptomatic congestive heart failure resulting in a resting O2 saturation of < 92% on
             room air, unstable angina pectoris, myocardial infarction within the previous 6
             months, or use of ongoing maintenance therapy for life-threatening ventricular
             arrhythmia, known pulmonary hypertension or pneumonitis

          -  Patients in a severely compromised immunological state, including being positive for
             the human immunodeficiency virus (HIV) due to possible pharmacokinetic interactions
             with HAART therapy

          -  Patients diagnosed with acute or chronic hepatitis B or C

          -  Patients using immunosuppressive agents, including intravenous corticosteroids, within
             3 weeks of study entry

          -  Patients must not have a history of any other cancer (except nonmelanoma skin cancer),
             unless in complete remission and off of all therapy for that disease for a minimum of
             3 years