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

Asan Medical Center1 site in 1 country364 target enrollmentOctober 2012

ConditionsProstatic Neoplasms

InterventionsAtorvastatin 20mg

DrugsAtorvastatin 20mg

Overview

Phase: Phase 2
Intervention: Atorvastatin 20mg
Conditions: Prostatic Neoplasms
Sponsor: Asan Medical Center
Enrollment: 364
Locations: 1
Primary Endpoint: Rate of biochemical recurrence
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

September 30, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Asan Medical Center

Responsible Party

Principal Investigator

In Gab Jeong, MD

professor

Asan Medical Center

Eligibility Criteria

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

•Patients who have received neoadjuvant androgen deprivation therapy
•Patients who have the participation of other clinical trial within the past 3 months
•Patients who have treated with statin
•Patients who have lymph node metastasis or distant metastasis
•Patients who have 10 year risk of cardiovascular disease over 10% based on NCEP ATP III guideline.