A Pilot Study of Atorvastatin on Prevention of Metabolic Syndrome in Subjects With Prostate Cancer on 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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.
At 6 months
No
Jue Wang
Principal Investigator
University of Nebraska
United States: Institutional Review Board
429-11
NCT01555632
March 2012
February 2013
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