Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer
NCT ID: NCT01759836
Last Updated: 2022-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
364 participants
INTERVENTIONAL
2012-10-31
2021-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Atorvastatin 20mg
Atorvastatin 20mg daily for 1 year
Atorvastatin 20mg
Atorvastatin 20mg daily for 1 year
Placebo
Placebo daily for 1 year
Atorvastatin 20mg
Atorvastatin 20mg daily for 1 year
Interventions
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Atorvastatin 20mg
Atorvastatin 20mg daily for 1 year
Eligibility Criteria
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Inclusion 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
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.
MALE
No
Sponsors
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Dong-A Pharmaceutical
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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In Gab Jeong, MD
professor
Principal Investigators
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Choung-Soo Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Urology,Asan Medical Center, Seoul
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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Jeong IG, Lim B, Yun SC, Lim JH, Hong JH, Kim CS. Adjuvant Low-dose Statin Use after Radical Prostatectomy: The PRO-STAT Randomized Clinical Trial. Clin Cancer Res. 2021 Sep 15;27(18):5004-5011. doi: 10.1158/1078-0432.CCR-21-0480. Epub 2021 May 19.
Other Identifiers
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AMC-PC2012002
Identifier Type: -
Identifier Source: org_study_id
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