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

January 9, 2022 updated by: In Gab Jeong, MD, Asan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

364

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atorvastatin 20mg
Atorvastatin 20mg daily for 1 year
Drug: Atorvastatin 20mg
Atorvastatin 20mg daily for 1 year
Placebo Comparator: Placebo
Placebo daily for 1 year
Drug: Atorvastatin 20mg
Atorvastatin 20mg daily for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of biochemical recurrence
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Biochemical recurrence free survival
Time Frame: Five years
Five years

Other Outcome Measures

Outcome Measure
Time Frame
Clinical progression-free survival
Time Frame: Five years
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Dong-A Pharmaceutical

Investigators

  • Principal Investigator: Choung-Soo Kim, MD, Department of Urology,Asan Medical Center, Seoul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

January 1, 2013

First Submitted That Met QC Criteria

January 2, 2013

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 9, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC-PC2012002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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