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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Atorvastatin 20mg


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin 20mg<br>Atorvastatin 20mg daily for 1 year | Drug: Atorvastatin 20mg<br>* Atorvastatin 20mg daily for 1 year<br>|
| Placebo Comparator: Placebo<br>Placebo daily for 1 year | Drug: Atorvastatin 20mg<br>* Atorvastatin 20mg daily for 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of biochemical recurrence |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical recurrence free survival |  | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatectomy, Statins