Impact of Adjuvant Statin Therapy in Patients Who Underwe... | NCT01759836

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

NCT01759836

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Jan 25, 2022Actual

Enrollment

364Actual

Phase

Phase 2

Conditions

Prostatic Neoplasms

Interventions

Atorvastatin 20mg

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Sep 30, 2021Actual

Completion Date

Sep 30, 2021Actual

First Submitted Date

Jan 1, 2013

First Submission Date that Met QC Criteria

Jan 2, 2013

First Posted Date

Jan 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2022

Last Update Posted Date

Jan 25, 2022Actual

Name	Class
Dong-A Pharmaceutical	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

364Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atorvastatin 20mg	Experimental	Atorvastatin 20mg daily for 1 year	Drug: Atorvastatin 20mg
Placebo	Placebo Comparator	Placebo daily for 1 year	Drug: Atorvastatin 20mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin 20mg	Drug	Atorvastatin 20mg daily for 1 year	Atorvastatin 20mg Placebo

Measure	Description	Time Frame
Rate of biochemical recurrence		One year

Measure	Description	Time Frame
Biochemical recurrence free survival		Five years

Measure	Description	Time Frame
Clinical progression-free survival		Five years

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Choung-Soo Kim, MD	Department of Urology,Asan Medical Center, Seoul	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul		138-736	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34011557	Background	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.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds