Atorvastatin Calcium in Preventing Metabolic Syndrome in Patients With Prostate Cancer Receiving Long-Term Androgen-Deprivation Therapy
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Drug: atorvastatin calcium
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Atorvastatin on Prevention of Metabolic Syndrome in Subjects With Prostate Cancer on Long Term Androgen-deprivation Therapy|
- Overall change of metabolic syndrome score (divided into 6 groups according to the number of constituents [0-5] of metabolic syndrome) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
- Change in Safety and tolerability of atorvastatin calcium [ Time Frame: Adverse Events (AE) at 3 and 6 months ] [ Designated as safety issue: Yes ]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.
- Impact of atorvastatin calcium on mean change in PSA and PSA velocity [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
- Optional collection and banking of blood and serum on subjects for future analysis [ Time Frame: Number of samples collected at baseline and then at 3 and 6 months ] [ Designated as safety issue: No ]Optional samples collected for future research that will be proposed in future IRB submissions.
|Study Start Date:||March 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Arm I (placebo)
Patients receive placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
Other Name: PLCB
Experimental: Arm II (atorvastatin calcium)
Patients receive atorvastatin calcium PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
Drug: atorvastatin calcium
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555632
|Principal Investigator:||Jue Wang||University of Nebraska|