A Pilot Study of Atorvastatin on Prevention of Metabolic Syndrome in Subjects With Prostate Cancer on Long Term Androgen-deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Overall change of metabolic syndrome score (divided into 6 groups according to the number of constituents [0-5] of metabolic syndrome)
研究概览
简要总结
This randomized pilot clinical trial studies atorvastatin calcium in preventing metabolic syndrome in patients with prostate cancer receiving long-term androgen-deprivation therapy. Atorvastatin calcium may help prevent or reduce metabolic syndrome caused by long-term androgen-deprivation therapy
详细描述
PRIMARY OBJECTIVES:
I. To evaluate in a pilot study a preliminary estimate of the overall change of metabolic syndrome score in men undergoing or who have undergone androgen-deprivation therapy for treatment or the control of prostate cancer.
II. To assess the effectiveness of Atorvastatin (atorvastatin calcium) on the prevention of metabolic syndrome in men undergoing or who have undergone androgen-deprivation therapy for treatment or the control of prostate cancer.
SECONDARY OBJECTIVES:
I. To document the safety and tolerability of Atorvastatin in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed prostate cancer, any stage disease allowed Androgen deprivation for treatment or control of prostate cancer including any of the following:
- •Bilateral orchiectomy
- •Luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide, goserelin, bicalutamide, flutamide, or similar agents) with or without antiandrogen therapy
- •No statin therapy, antihyperlipidemic, lipid-lowering medications, HMG-COA reductase inhibitor, atorvastatin calcium, or LIPITOR ® use
- •Patients must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care based on current diagnosis and clinical condition, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- •Karnofsky Performance Status >= 70
- •Able to adhere to the study visit schedule and other protocol requirements
- •No serious disease or condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study
- •Absolute neutrophil count (ANC) >= 1000 cells/mm^3
- •Platelet Count >= 100 mm^3
- •Serum creatinine < 2.0 mg/dL
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 2 x the upper limits of normal
- •Hepatic alkaline phosphatase < 2 x the upper limits of normal
排除标准
- •Treatment with a cytotoxic chemotherapy or participation in any other studies involving investigational or marketed products, concomitantly within 30 days before Day 1 of study treatment; palliative radiation therapy is allowed
- •Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C or active Hepatitis
- •Known alcohol and/or any other drug abuse
- •History of intolerance or hypersensitivity to statins and known hypersensitivity to atorvastatin
- •Known history of non-low-density lipoprotein (LDL) cholesterol > 150 mg/dL, peripheral artery disease, coronary heart disease, myocardial infarction (MI) or angina, coronary artery disease or diabetes (as should be receiving statin therapy per current standards); in addition, patients with a known history of smoking, hypertension, family history of myocardial events, and non-LDL > 100 mg/dL
- •Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) as assessed by the investigator
- •Known cerebrovascular accidents within 6 months before Day 1 of study treatment
- •Treatment with drugs not permitted by the study protocol or the likelihood of requiring treatment during the study period with drugs which might interfere with the absorption and evaluation of study drugs during the study protocol
- •Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
研究组 & 干预措施
Arm I (placebo)
Patients receive placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: placebo (Drug)
Arm II (atorvastatin calcium)
Patients receive atorvastatin calcium PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: atorvastatin calcium (Drug)
结局指标
主要结局
Overall change of metabolic syndrome score (divided into 6 groups according to the number of constituents [0-5] of metabolic syndrome)
时间窗: At 6 months
A total of 60 subjects will yield 80% power at the 0.05 two-sided level of significance to detect 3.40 difference of the mean change in metabolic syndrome scores after 6 months between arms using a Mann-Whitney test.
Change in effectiveness of atorvastatin calcium on the prevention of metabolic syndrome
时间窗: At 3 and 6 months
The overall change of metabolic syndrome score is evaluated in men undergoing or who have undergone androgen-deprivation therapy for treatment or the control of prostate cancer.
次要结局
- Optional collection and banking of blood and serum on subjects for future analysis(Number of samples collected at baseline and then at 3 and 6 months)
- Change in Safety and tolerability of atorvastatin calcium(Adverse Events (AE) at 3 and 6 months)
- Impact of atorvastatin calcium on mean change in PSA and PSA velocity(At 3 and 6 months)