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

Phase 2

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Drug: Atorvastatin 20mg

• Registration Number: NCT01759836
• Lead Sponsor: Asan Medical Center

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

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-01
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-03
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-09
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 364

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Atorvastatin 20mg	Placebo daily for 1 year
Atorvastatin 20mg	Atorvastatin 20mg	Atorvastatin 20mg daily for 1 year

Primary Outcome Measures

Name	Time	Method
Rate of biochemical recurrence	One year

Secondary Outcome Measures

Name	Time	Method
Biochemical recurrence free survival	Five years

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of