NCT01759836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

9 years

First QC Date

January 1, 2013

Last Update Submit

January 9, 2022

Conditions

Prostatic Neoplasms

Keywords

ProstatectomyStatins

Outcome Measures

Primary Outcomes (1)

  • Rate of biochemical recurrence

    One year

Secondary Outcomes (1)

  • Biochemical recurrence free survival

    Five years

Other Outcomes (1)

  • Clinical progression-free survival

    Five years

Study Arms (2)

Atorvastatin 20mg

EXPERIMENTAL

Atorvastatin 20mg daily for 1 year

Drug: Atorvastatin 20mg

Placebo

PLACEBO COMPARATOR

Placebo daily for 1 year

Drug: Atorvastatin 20mg

Interventions

Atorvastatin 20mgDRUG

Atorvastatin 20mg daily for 1 year

Atorvastatin 20mgPlacebo

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 34011557BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Choung-Soo Kim, MD

    Department of Urology,Asan Medical Center, Seoul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 1, 2013

First Posted

January 3, 2013

Study Start

October 1, 2012

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

KR(1)