Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer

Asan Medical Center364 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

364

Conditions

Prostatic Neoplasms

Interventions

Atorvastatin 20mgDRUG

Atorvastatin 20mg daily for 1 year

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. Patients must have pathologically adenocarcinoma 3. Patients must be enrolled within 60 days after radical prostatectomy 4. Patients must be able to provide written informed consent Exclusion Criteria: 1. Patients who have received neoadjuvant androgen deprivation therapy 2. Patients who have the participation of other clinical trial within the past 3 months 3. Patients who have treated with statin 4. Patients who have lymph node metastasis or distant metastasis 5. Patients who have 10 year risk of cardiovascular disease over 10% based on NCEP ATP III guideline.

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Rate of biochemical recurrence

Time frame: One year

Secondary Outcomes

Biochemical recurrence free survival

Time frame: Five years

Data from ClinicalTrials.gov

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