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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Given PO
Given PO
Overall change of metabolic syndrome score (divided into 6 groups according to the number of constituents [0-5] of metabolic syndrome)
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.
Time frame: At 6 months
Change in effectiveness of atorvastatin calcium on the prevention of metabolic syndrome
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.
Time frame: At 3 and 6 months
Change in Safety and tolerability of atorvastatin calcium
Safety will be assessed when approx 30 patients (50%) have completed the 3 month assessment based on the frequency and % of adverse events. 5 patients experiencing any non-hematologic, non-androgen deprivation related grade 3 or greater AE would trigger a systematic review of the AE experience. The frequency of AEs will be compared between the placebo and Atorvastatin groups using a Fisher's Exact test. A p-value of 0.20 will be considered significant for the interim assessment.
Time frame: Adverse Events (AE) at 3 and 6 months
Impact of atorvastatin calcium on mean change in PSA and PSA velocity
The effectiveness of Atorvastatin (atorvastatin calcium) on the prevention of metabolic syndrome is evaluated in men undergoing or who have undergone androgen-deprivation therapy for treatment or the control of prostate cancer.
Time frame: At 3 and 6 months
Optional collection and banking of blood and serum on subjects for future analysis
Optional samples collected for future research that will be proposed in future IRB submissions.
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Time frame: Number of samples collected at baseline and then at 3 and 6 months