Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin 20mg
Sponsored by
About this trial
This is an interventional prevention trial for Prostatic Neoplasms focused on measuring Prostatectomy, Statins
Eligibility Criteria
Inclusion Criteria:
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
- Patients must have pathologically adenocarcinoma
- Patients must be enrolled within 60 days after radical prostatectomy
- Patients must be able to provide written informed consent
Exclusion Criteria:
- Patients who have received neoadjuvant androgen deprivation therapy
- Patients who have the participation of other clinical trial within the past 3 months
- Patients who have treated with statin
- Patients who have lymph node metastasis or distant metastasis
- Patients who have 10 year risk of cardiovascular disease over 10% based on NCEP ATP III guideline.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Atorvastatin 20mg
Placebo
Arm Description
Atorvastatin 20mg daily for 1 year
Placebo daily for 1 year
Outcomes
Primary Outcome Measures
Rate of biochemical recurrence
Secondary Outcome Measures
Biochemical recurrence free survival
Full Information
NCT ID
NCT01759836
First Posted
January 1, 2013
Last Updated
January 9, 2022
Sponsor
Asan Medical Center
Collaborators
Dong-A Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01759836
Brief Title
Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Dong-A Pharmaceutical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostatectomy, Statins
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
364 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin 20mg
Arm Type
Experimental
Arm Description
Atorvastatin 20mg daily for 1 year
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily for 1 year
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20mg
Intervention Description
Atorvastatin 20mg daily for 1 year
Primary Outcome Measure Information:
Title
Rate of biochemical recurrence
Time Frame
One year
Secondary Outcome Measure Information:
Title
Biochemical recurrence free survival
Time Frame
Five years
Other Pre-specified Outcome Measures:
Title
Clinical progression-free survival
Time Frame
Five years
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Patients must have pathologically adenocarcinoma
Patients must be enrolled within 60 days after radical prostatectomy
Patients must be able to provide written informed consent
Exclusion Criteria:
Patients who have received neoadjuvant androgen deprivation therapy
Patients who have the participation of other clinical trial within the past 3 months
Patients who have treated with statin
Patients who have lymph node metastasis or distant metastasis
Patients who have 10 year risk of cardiovascular disease over 10% based on NCEP ATP III guideline.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choung-Soo Kim, MD
Organizational Affiliation
Department of Urology,Asan Medical Center, Seoul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
34011557
Citation
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.
Results Reference
background
Learn more about this trial
Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer
We'll reach out to this number within 24 hrs