Overview
Atorvastatin Calcium in Preventing Metabolic Syndrome in Patients With Prostate Cancer Receiving Long-Term Androgen-Deprivation Therapy
Status:
Withdrawn
Withdrawn
Trial end date:
2013-02-01
2013-02-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
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 therapyPhase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of NebraskaCollaborator:
National Cancer Institute (NCI)Treatments:
Androgens
Atorvastatin
Atorvastatin Calcium
Calcium
Calcium, Dietary
Criteria
Inclusion Criteria:- 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understanding that consent may be withdrawn by the subject at any time without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
Exclusion Criteria:
- 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