Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer

This is an interventional treatment trial for Adenocarcinoma of the Prostate Read More

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