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
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
Biochemical recurrence develops in approximately 30-40% of men with locally advanced prostate cancer who undergo radical prostatectomy. To date, the effect of statins on prostate cancer recurrence has been investigated in several retrospective studies with inconsistent results. The purpose of this study is to determine the impact of statin on biochemical recurrence after 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
Inclusion Criteria:
Patients must have correspond to one of the following three pathologic criteria.
A. Gleason scores 8 or greater B. Positive resection margin C. pT3-T4
Patients must have pathologically adenocarcinoma
Patients must be enrolled within 60 days after radical prostatectomy
Patients must be able to provide written informed consent
Exclusion Criteria: