Atorvastatin Calcium in Preventing Metabolic Syndrome in Patients With Prostate Cancer Receiving Long-Term Androgen-Deprivation Therapy

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.

II. To assess the impact of Atorvastatin on mean change in prostate specific antigen (PSA)
and PSA velocity.

III. The collection and banking of blood and serum on subjects for future analysis that will
be proposed in future institutional review board (IRB) submissions.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive placebo orally once daily for 6 months in the absence of disease
progression or unacceptable toxicity.

ARM II: Patients receive atorvastatin calcium orally once daily for 6 months in the absence
of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, and at 6 months
thereafter.

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condition, with the understanding that consent may be withdrawn by the subject at any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