Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT00512668
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
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00512668
Study Brief:
Protocol Section:
NCT00512668