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

This study is currently recruiting participants.
Verified January 2013 by Asan Medical Center
Sponsor:
Collaborator:
Dong-A Pharmaceuticals. Inc
Information provided by (Responsible Party):
Choung-Soo Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01759836
First received: January 1, 2013
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
 Drug: Atorvastatin 20mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Rate of biochemical recurrence [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical recurrence free survival [ Time Frame: Five years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Clinical progression-free survival [ Time Frame: Five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 354
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759836

Contacts
Contact: Choung-Soo Kim, MD 82-2-3010-3734 ext No cskim@amc.seoul.kr
Contact: In Gab Jeong, MD 82-2-3010-5892 ext No igjeong@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Choung-Soo Kim, MD     82-2-3010-3734 ext No     cskim@amc.seoul.kr    
Contact: In Gab Jeong, MD     82-2-3010-5892 ext No     igjeong@amc.seoul.kr    
Principal Investigator: Choung-soo Kim, MD            
Sponsors and Collaborators
Asan Medical Center
Dong-A Pharmaceuticals. Inc
Investigators
Principal Investigator: Choung-Soo Kim, MD Department of Urology,Asan Medical Center, Seoul
  More Information

No publications provided

Responsible Party: Choung-Soo Kim, professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01759836     History of Changes
Other Study ID Numbers: AMC-PC2012002
Study First Received: January 1, 2013
Last Updated: January 9, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Prostatectomy
Statins

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013