Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer
Conditions
Prostatic Neoplasms
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
Prostatectomy, Statins
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Intervention
Name: Atorvastatin 20mg
Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Male
Criteria: 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.
Location
Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Choung-Soo Kim, MD - 82-2-3010-3734 - cskim@amc.seoul.kr
Start Date
October 2012
Completion Date
October 2015
Sponsors
Asan Medical Center
Source
Asan Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page