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

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborators: Dong-A Pharmaceutical; Dong-A Pharmaceuticals. Inc
• Treatments: Atorvastatin; Atorvastatin Calcium

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.