A Randomized Double Blind, Placebo-controlled Study Determining the Role of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer
Estimated Enrollment: 354
Study start date: October 2012
Estimated Study Completion Date: October 2015
Statin Group: Treatment with Atorvastatin 20mg daily after radical prostatectomy during 1
year.
Control Group: Treatment with Placebo daily after radical prostatectomy during 1 year.
Follow up: every 3 months for the first year. Check PSA, Total/LDL-cholesterol and
Triglyceride.
Primary End Point Rate of Biochemical recurrence
Secondary End Point Clinical progression of prostate cancer Change of Total/LDL- cholesterol
and Triglycerides 5 year-Biochemical recurrence free survival
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Rate of biochemical recurrence
One year
No
Choung-Soo Kim, MD
Principal Investigator
Department of Urology,Asan Medical Center, Seoul
Korea: Institutional Review Board
AMC-PC2012002
NCT01759836
October 2012
October 2015
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